<h3>Job Description</h3>
Job Description
About Vitalief Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. Our team combines deep clinical research expertise with results-driven consulting to help organizations operate more efficiently and grow sustainably. The Role Vitalief is seeking a highly organized and detail-oriented Mid-Level Project Manager to provide operational oversight and coordination for our client’s Pediatric Acute Leukemia clinical trials. This full-time, fully benefited role serves as the primary liaison between the pharmaceutical clinical research team and CROs, ensuring trials are executed efficiently, on budget, and in compliance with regulatory standards. The Project Manager bridges scientific and operational aspects of clinical research, leading cross-functional teams to deliver high-quality studies evaluating the safety and efficacy of pharmaceuticals. WHY VITALIEF?&nbsp;
<ul>
<li>Contribute to advancing scientific discoveries that improve patient lives.</li>
<li>PEOPLE FIRST culture with opportunities for growth and innovation.</li>
<li>Competitive benefits include 20 PTO days + 9 paid holidays; Company-paid life insurance and short/long-term disability; 401(k) retirement program; Comprehensive healthcare plans.</li>
<li>Salary Range:&nbsp; $70,000 to $80,000 &nbsp;(commensurate with experience).</li>
<li>Work Location: 100% Remote&nbsp; (seeking only candidates that live in the EST Zone).</li>
</ul>
 KEY RESPONSIBILITIES Trial Planning and Initiation
<ul>
<li>Support bid strategies and contract discussions with CROs, including site selection and patient enrollment.</li>
<li>Review and finalize trial protocols and related documents.</li>
<li>Build project plans, timelines, and vendor assessments.</li>
<li>Establish and maintain collaborative relationships with sponsors, CROs, vendors, investigators, and site staff.</li>
</ul>
Trial Execution and Management
<ul>
<li>Monitor study activities for compliance with protocols and regulatory requirements.</li>
<li>Identify potential delays or out-of-scope work and implement mitigations.</li>
<li>Manage study risks and escalate issues to leadership as needed.</li>
<li>Oversee study documentation, including case report forms, drug records, and regulatory filings.</li>
<li>Motivate team members and investigators to achieve trial objectives.</li>
</ul>
Stakeholder Management
<ul>
<li>Maintain regular communication with sponsors and internal teams.</li>
<li>Conduct status meetings and provide updates to leadership and stakeholders.</li>
<li>Develop realistic budgets and timelines.</li>
</ul>
Quality and Compliance
<ul>
<li>Ensure audit readiness and compliance with ICH/GCP, FDA, IRB/IEC, and SOP requirements.</li>
<li>Review monitoring reports and support development of study materials, processes, and committees.</li>
<li>Anticipate and mitigate project risks.</li>
</ul>
 QUALIFICATIONS Education and Experience
<ul>
<li>Bachelor’s degree in life sciences, nursing, pharmacy, medical sciences, or related field preferred.</li>
<li>5 or more years of clinical research experience, including oversight of multicenter or complex studies; oncology experience highly preferred.</li>
<li>2 or more years of experience in a clinical trials oversight capacity as a project manager, ideally working for a sponsor or a CRO. </li>
<li>Project management certification (CCPM or PMP) preferred.</li>
</ul>
<ul>
<li>Knowledge of clinical trial practices and project management principles.</li>
<li>Strong organizational, communication, and interpersonal skills.</li>
<li>Ability to manage multiple projects, deadlines, and budgets effectively.</li>
<li>Proven leadership and collaboration skills in multi-level team settings.</li>
<li>Problem-solving and decision-making abilities in fast-paced, dynamic environments.</li>
</ul>
 PHYSICAL DEMANDS: Prolonged periods sitting working on a computer, standing, walking, visual perception, talking and hearing. Lifting up to 20lbs.
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Clinical Trial Mid-Level Project Manager

<h3>Job Description</h3>
Job DescriptionSalary: $125,000 - $140,000 
We are looking for an experienced Associate Director of Operations to join our team!
 
Are you a self-driven leader who can provide excellent leadership and oversight to the Operations team while promoting team effort and accountability? Can you quickly respond to unexpected changes and make sound decisions? Someone who is able to see the bigger picture without losing sight of the day-to-day tasks? If so, keep reading!

This role is ideal for an individual who can motivate cross-functional teams to collaboratively work together to produce the best quality outcome and foster positive relationships. 
 
Responsibilities:

Strategic Input
<ul>
<li>Support the Director of Operations and Executive Director in defining and carrying forward strategic objectives at the organizational level.</li>
<li>Support the development and implementation of annual goals and performance metrics for the CPC Operations teams (Clinical Operations, Site Operations, and Endpoint &amp; Specialty Services [ESS]) in collaboration with functional area leaders and the Leadership Committee.</li>
<li>Ensure proactive assessment and identification of project issues by functional area leaders and support teams in developing and implementing risk mitigation strategies.</li>
</ul>
Leadership and Management
<ul>
<li>Provide oversight, management, and leadership for Operations. </li>
<li>Supervise, coach, and mentor team members, setting clear job expectations, assessing training needs, and ensuring team members receive necessary training.</li>
</ul>
Quality and Compliance
<ul>
<li>Oversee the quality, accuracy, and timeliness of deliverables from the Operations teams. </li>
<li>Ensure CPC Operations teams compliance with applicable policies, standard operating procedures (SOPs), work instructions (WIs), and relevant regulations and guidelines.</li>
<li>Review, and approve applicable policies, SOPs, and WIs. Work closely with team members to create and improve these documents.</li>
</ul>
Project Management
<ul>
<li>Function as an Executive Clinical Operations Manager or Project Manager for projects, as needed.</li>
<li>Provide mentoring, support, and backup for all relevant project activities.</li>
<li>Provide regular updates to supervisors on staff, key performance indicators, timelines, and deliverables.</li>
<li>Work with the team to identify and implement best practices for optimizing performance and increasing efficiencies.</li>
</ul>
Resource Allocation
<ul>
<li>Ensure appropriate resourcing and personnel allocation for evolving business and project needs within Operations.</li>
</ul>
Business Development
<ul>
<li>Assist Business Development with benchmarking for budgets and development of proposals and service agreements. </li>
</ul>
Executive Management
<ul>
<li>Support the Director of Operations, Director of Informatics, Biostatistics and Data Management and Leadership Committee to ensure optimal procurement, implementation, and adoption of systems used to support the CPC Operations team; identify and support system owners.</li>
<li>Oversee the accurate and timely recognition of project specific revenue; ensure accurate revenue forecasting for all assigned projects. </li>
</ul>
Perform additional activities as required.

Qualifications:
 
<ul>
<li>BA/BS in a scientific field. Advanced degree preferred. </li>
<li>A minimum of 10 years of experience clinical research (or equivalent) experience</li>
<li>A minimum of 5 years in clinical trial management (or equivalent) experience</li>
<li>A minimum of 3 years of supervisory experience</li>
<li>Thorough knowledge of Good Clinical Practice guidelines and applicable FDA and ICH regulations for conducting clinical drug trials</li>
<li>Proficiency in MS Office including Project, PowerPoint, Word, and Excel</li>
<li>Excellent interpersonal communication skills</li>
<li>Strong analytical and reasoning skills</li>
<li>Ability to work as a member of a team and to organize, instruct, and supervise staff while promoting group effort and achievement</li>
<li>Ability to manage conflicts and resolve problems effectively</li>
<li>Commitment to accountability and passion for the organization's mission, vision, and values</li>
<li>Ability and willingness to travel up to 15%</li>
</ul>
 
Targeted Compensation:$125,000 - $140,000 annually 
 
Deadline to Apply: November1, 2025
 
About CPC: 

CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas.With over 35 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more. 
 
CPC has expertise in managing clinical trials from a variety of funding sources including industry, NIH, and Investigator Initiated trials. 
 
CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy.<a href="http://www.cpccommunityhealth.org/" target="_blank">http://www.cpccommunityhealth.org/</a> 

CPC offers: 

 Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.) 
 Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately) 
 11 paid holidays 
 15 - 25 vacation days based on years of service 
 Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) 
 In-suite exercise and relaxation room 
 Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics) 
 Flexible and remote work schedules 
 
An Equal Opportunity Employer

CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.

Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at <a href="mailto:careers@cpcmed.org" target="_blank">careers@cpcmed.org</a>.

Associate Director of Clinical Trial Operations

<h3>Job Description</h3>
Job DescriptionSalary: $125,000 - $140,000 
We are looking for an experienced Associate Director of Operations to join our team!
 
Are you a self-driven leader who can provide excellent leadership and oversight to the Operations team while promoting team effort and accountability? Can you quickly respond to unexpected changes and make sound decisions? Someone who is able to see the bigger picture without losing sight of the day-to-day tasks? If so, keep reading!

This role is ideal for an individual who can motivate cross-functional teams to collaboratively work together to produce the best quality outcome and foster positive relationships. 
 
Responsibilities:

Strategic Input
<ul>
<li>Support the Director of Operations and Executive Director in defining and carrying forward strategic objectives at the organizational level.</li>
<li>Support the development and implementation of annual goals and performance metrics for the CPC Operations teams (Clinical Operations, Site Operations, and Endpoint &amp; Specialty Services [ESS]) in collaboration with functional area leaders and the Leadership Committee.</li>
<li>Ensure proactive assessment and identification of project issues by functional area leaders and support teams in developing and implementing risk mitigation strategies.</li>
</ul>
Leadership and Management
<ul>
<li>Provide oversight, management, and leadership for Operations. </li>
<li>Supervise, coach, and mentor team members, setting clear job expectations, assessing training needs, and ensuring team members receive necessary training.</li>
</ul>
Quality and Compliance
<ul>
<li>Oversee the quality, accuracy, and timeliness of deliverables from the Operations teams. </li>
<li>Ensure CPC Operations teams compliance with applicable policies, standard operating procedures (SOPs), work instructions (WIs), and relevant regulations and guidelines.</li>
<li>Review, and approve applicable policies, SOPs, and WIs. Work closely with team members to create and improve these documents.</li>
</ul>
Project Management
<ul>
<li>Function as an Executive Clinical Operations Manager or Project Manager for projects, as needed.</li>
<li>Provide mentoring, support, and backup for all relevant project activities.</li>
<li>Provide regular updates to supervisors on staff, key performance indicators, timelines, and deliverables.</li>
<li>Work with the team to identify and implement best practices for optimizing performance and increasing efficiencies.</li>
</ul>
Resource Allocation
<ul>
<li>Ensure appropriate resourcing and personnel allocation for evolving business and project needs within Operations.</li>
</ul>
Business Development
<ul>
<li>Assist Business Development with benchmarking for budgets and development of proposals and service agreements. </li>
</ul>
Executive Management
<ul>
<li>Support the Director of Operations, Director of Informatics, Biostatistics and Data Management and Leadership Committee to ensure optimal procurement, implementation, and adoption of systems used to support the CPC Operations team; identify and support system owners.</li>
<li>Oversee the accurate and timely recognition of project specific revenue; ensure accurate revenue forecasting for all assigned projects. </li>
</ul>
Perform additional activities as required.

Qualifications:
 
<ul>
<li>BA/BS in a scientific field. Advanced degree preferred. </li>
<li>A minimum of 10 years of experience clinical research (or equivalent) experience</li>
<li>A minimum of 5 years in clinical trial management (or equivalent) experience</li>
<li>A minimum of 3 years of supervisory experience</li>
<li>Thorough knowledge of Good Clinical Practice guidelines and applicable FDA and ICH regulations for conducting clinical drug trials</li>
<li>Proficiency in MS Office including Project, PowerPoint, Word, and Excel</li>
<li>Excellent interpersonal communication skills</li>
<li>Strong analytical and reasoning skills</li>
<li>Ability to work as a member of a team and to organize, instruct, and supervise staff while promoting group effort and achievement</li>
<li>Ability to manage conflicts and resolve problems effectively</li>
<li>Commitment to accountability and passion for the organization's mission, vision, and values</li>
<li>Ability and willingness to travel up to 15%</li>
</ul>
 
Targeted Compensation:$125,000 - $140,000 annually 
 
Deadline to Apply: August1, 2025
 
About CPC: 

CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas.With over 35 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more. 
 
CPC has expertise in managing clinical trials from a variety of funding sources including industry, NIH, and Investigator Initiated trials. 
 
CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy.<a href="http://www.cpccommunityhealth.org/" target="_blank">http://www.cpccommunityhealth.org/</a> 

CPC offers: 

 Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.) 
 Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately) 
 11 paid holidays 
 15 - 25 vacation days based on years of service 
 Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) 
 In-suite exercise and relaxation room 
 Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics) 
 Flexible and remote work schedules 
 
An Equal Opportunity Employer

CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.

Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at <a href="mailto:careers@cpcmed.org" target="_blank">careers@cpcmed.org</a>.
 remote work

<h3>Job Description</h3>
Job DescriptionSystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. We are seeking a highly skilled and motivated Clinical Project Manager (CPM) to join our dynamic team. The successful candidate will oversee and coordinate clinical trials from initiation through to completion. This role involves ensuring compliance with regulatory requirements, managing study timelines and budgets, and fostering effective communication among stakeholders.&nbsp; The CPM will play a critical role in delivering high-quality data and ensuring the success of clinical studies. Responsibilities
<ul>
<li>Oversee the planning and execution of clinical trials</li>
<li>Develop and implement study protocols, timelines, and budgets.</li>
<li>Manage all aspects of clinical trial operations, including site selection, initiation, monitoring, and closeout.</li>
<li>Ensure compliance with Good Clinical Practice (GCP) and regulatory guidelines.</li>
<li>Coordinate with cross-functional teams, including investigators, vendors, and regulatory bodies.</li>
<li>Monitor trial progress and manage data collection to ensure accuracy and integrity.</li>
<li>Identify and mitigate project risks</li>
<li>Prepare and submit regulatory documents and maintain trial documentation.</li>
<li>Conduct regular meetings with study teams and provide updates to stakeholders.</li>
<li>Coordinate with external vendors and partners involved in the trial</li>
<li>Support development of key process initiatives and SOPs internally</li>
<li>Conduct site visits to ensure compliance with protocols</li>
</ul>
Qualifications
<ul>
<li>Bachelor’s degree in Life Sciences, Nursing, or a related field.</li>
<li>Minimum of 5 years of experience in Clinical Trial Management</li>
<li>Strong understanding of GCP and regulatory requirements.</li>
<li>Excellent organizational and project management skills.</li>
<li>Proven ability to lead cross-functional teams and manage multiple priorities.</li>
<li>Strong communication and interpersonal skills.</li>
<li>Ability to work collaboratively in a team-oriented environment</li>
<li>Flexibility and adaptability to changing priorities and workload</li>
</ul>
Preferred Qualifications:
<ul>
<li>Master’s degree in a related field or clinical research certification (e.g., ACRP or SOCRA).</li>
<li>Experience with electronic data capture (EDC) systems and clinical trial management software.</li>
<li>Prior experience in running or supporting Oncology clinical trials a plus.</li>
<li>Previous experience in a sponsor or CRO environment.</li>
</ul>
Location/Travel:
<ul>
<li>Princeton Hybrid 3days/week.&nbsp; Remote also considered with quarterly visits to Princeton.</li>
<li>Overnight travel ~25%</li>
</ul>
 Compensation and Benefits: The expected base salary range for this position is $110,000 - $150,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills. While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role. &nbsp; SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE. &nbsp; We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. &nbsp; SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
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OlyUJGe7AM

Clinical Project Manager

<h3>Job Description</h3>
Job Description
We are looking for a Clinical Trials Project Manager II to join our team!
APPLY DIRECTLY at <a href="https://cpcclinicalresearch.org/careers/" target="_blank">https://cpcclinicalresearch.org/careers/</a> (internal title Clinical Operations Manager II)
Are you well organized, but adaptable to unexpected changes? Someone who is able to see the bigger picture, without losing sight of the day-to-day tasks? If the answer is yes, keep reading!
This role serves as the primary point of contact for industry sponsored clinical trials and Endpoint and Specialty Services activities.
In this position you will:
<ul>
<li>Oversee clinical operations management activities</li>
<li>Define and monitor project scope, timelines and deliverables from project initiation to close-out.</li>
<li>Identify project-specific training for team members and notify appropriate designee to ensure completion and filing of training documentation.</li>
<li>Oversee trial-related activities.</li>
<li>Track and approve vendor payments.</li>
<li>Provide expert advice in the design, writing and/or review of all project-related essential documents including protocols, project management plans, case report forms, statistical analysis plans, project management plans, ICF templates, study procedure manuals, source documents, site newsletters, study reports, resource tools, essential documents, monitoring plans and report templates.</li>
<li>Develop and manage multidisciplinary project team members. Organize, plan for, and produce minutes for project team meetings.</li>
<li>Ensure the overall quality of project services and deliverables.</li>
<li>Provide necessary updates and reports to the sponsor as outlined by the contract.</li>
<li>Plan and oversee the execution of investigator meetings as contracted.</li>
<li>Work with the Business Development team on budgets, proposals and change orders.</li>
<li>Ensure both CPC and sponsor are aware of and in agreement on any change in project scope that has a financial or resource impact.</li>
<li>Provide Head of Trial Master File scope of services to enable him/her to establish and maintain Trial Master Files (TMFs) and project document files, both electronic and paper.</li>
<li>Adhere to local, federal and international regulations, guidelines and CPC Policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs). Use appropriate discretion to proactively identify when there is a need to deviate from policies, procedures or plans and ensure deviations are appropriately documented.</li>
<li>Define and monitor Endpoint and Specialty Services scope, timelines and deliverables from project initiation to closeout with assistance from study assigned Clinical Operations Manager and the Head of Endpoint and Specialty Services.</li>
<li>Manage contracted deliverables for external committees (e.g. data safety monitoring boards, clinical endpoint committees), including but not limited to meeting scheduling, generation of meeting minutes and distribution of meeting materials.</li>
<li>Oversee SAE process and assure execution of safety plans.</li>
<li>Accurately track receipt, entry, upload and the processing of photos, acetate tracings, and other source documents submitted from sites.</li>
<li>Contact appropriate individuals (e.g., study site staff or study site Clinical Research Associate) regarding incomplete, inaccurate, or missing photos, acetate tracings, and other Endpoint and Specialty Services Core Lab documents as required by the project.</li>
<li>Oversee timely and accurate entry and cleaning of data for all study databases; maintain and file data management documentation as required.</li>
<li>Provide feedback to study sites on tracing and quality issues, as required by project.</li>
<li>Manage and conduct Endpoint and Specialty Services CPC Core Lab activities.</li>
<li>Provide operational support for the biostatistics and programming deliverables.</li>
</ul>
Here’s what you will need to bring to the table:
<ul>
<li>Nursing or BA/BS in a scientific field (or equivalent knowledge/experience).</li>
<li>4 years of experience in a clinical research setting, including a minimum of 2 years of project/operations management experience in clinical research (required).</li>
<li>Demonstrated ability to adequately manage all facets of a clinical trial with minimal direction.</li>
<li>Thorough knowledge of the Good Clinical Practice guidelines and applicable FDA and ICH regulations for conducting clinical drug trials.</li>
<li>Proficiency in Microsoft Office, particularly Outlook, Word and Excel.</li>
<li>Excellent communication and organizational skills.</li>
<li>Great attention to detail.</li>
<li>Exemplary skills leading and managing multi-disciplinary teams in a clinical research setting.</li>
<li>Ability to organize, instruct and oversee project staff, while promoting group effort and achievement.</li>
<li>Ability to adapt quickly to new situations, manage conflicts and resolve problems effectively.</li>
<li>Willingness to travel 20-25%.</li>
</ul>
Note: Viable applicants will be required to pass a background and education verification check.
Targeted Compensation: $72,000 – $95,000 annually
Company DescriptionAbout CPC: CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 35 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more. CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials. CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. <a href="http://www.cpccommunityhealth.org/" target="_blank">http://www.cpccommunityhealth.org/</a> CPC offers: * Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.) * Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately) * 11 paid holidays * 15 - 25 vacation days based on years of service * Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) * Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics) * Flexible and remote work schedules available for certain positions Visit our web site to learn more about us and values we embrace: <a href="https://cpcclinicalresearch.org/" target="_blank">https://cpcclinicalresearch.org/</a>. An Equal Opportunity Employer CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors. Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at <a href="mailto:careers@cpcmed.org" target="_blank">careers@cpcmed.org</a>. 
<h3>Company Description</h3>
About CPC:\r\nCPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 35 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more. \r\n\r\nCPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.\r\n\r\nCPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. <a href="http://www.cpccommunityhealth.org/" target="_blank">http://www.cpccommunityhealth.org/</a> \r\n\r\nCPC offers:\r\n* Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)\r\n* Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)\r\n* 11 paid holidays\r\n* 15 - 25 vacation days based on years of service\r\n* Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) \r\n* Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)\r\n* Flexible and remote work schedules available for certain positions\r\n\r\nVisit our web site to learn more about us and values we embrace: <a href="https://cpcclinicalresearch.org/" target="_blank">https://cpcclinicalresearch.org/</a>.\r\n\r\nAn Equal Opportunity Employer\r\nCPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.\r\n\r\nApplicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at <a href="mailto:careers@cpcmed.org" target="_blank">careers@cpcmed.org</a>.

Clinical Trials Project Manager II - remote

<h3>Job Description</h3>
Job Description
This is a remote position.
The Clinical Research Manager (CRM) is responsible for the strategic and operational oversight of clinical trials conducted across various phases. This role ensures that studies are executed in compliance with regulatory requirements, GCP/ICH guidelines, and internal SOPs. The CRM manages cross-functional teams, monitors timelines and budgets, and acts as the primary liaison between investigators, CROs, vendors, and internal stakeholders. Key Responsibilities: Lead the planning, execution, and management of clinical trials across multiple therapeutic areas and phases. Oversee site selection, study start-up, patient recruitment, data collection, and close-out activities. Ensure compliance with FDA, ICH-GCP, and other applicable regulatory standards. Develop and maintain project timelines, budgets, and resource plans. Supervise and mentor Clinical Research Associates (CRAs), Clinical Trial Assistants (CTAs), and study coordinators. Review and approve study documentation including protocols, CRFs, informed consent forms, and monitoring reports. Coordinate with cross-functional teams including regulatory affairs, data management, biostatistics, and medical writing. Manage vendor and CRO relationships, including contract negotiations and performance monitoring. Track and report on study metrics and provide regular updates to senior leadership. Oversee the preparation and conduct of audits and regulatory inspections. Minimum Qualifications: Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field (Master’s or Ph.D. preferred). Minimum of 5–7 years of experience in clinical research, including 2+ years in a managerial or supervisory role. In-depth knowledge of clinical trial processes, ICH-GCP guidelines, and regulatory requirements. Proven experience managing Phase I-IV trials across multiple therapeutic areas. Strong project management, leadership, and team coordination skills. Excellent written and verbal communication abilities. Proficiency with clinical trial software (e.g., CTMS, EDC, eTMF platforms). Ability to travel up to 20% as needed. In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well-being. Our benefits include paid holidays, Paid Time Off (PTO) policy, and medical insurance to ensure our team members have the flexibility and coverage they need. We believe in fostering a healthy work-life balance while providing the necessary support for professional and personal growth. Be part of our network of Subject Matter Experts. 
E-Verify Participation: 
Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888-897-7781 or through their website at dhs.gov/e-verify.

Clinical Research Manager

<h3>Job Description</h3>
Job Description
Job Title: Manager, Clinical Research Finance
Job Description
The Manager of Clinical Research Finance is responsible for ensuring the strategic vision, direction, and operations of the clinical research finance department are successfully implemented. Under the supervision of the Director, this role involves overseeing day-to-day operations, ensuring regulatory compliance, and fostering communication between ministries, stakeholders, and leadership. The manager will also assist in developing and maintaining policies, as well as providing both formal and informal training for research staff.
Responsibilities
<ul>
<li>Oversee the development of research contracting and budgeting standards.</li>
<li>Direct the negotiation of contracts for clinical trials and the determination of internal costs.</li>
<li>Develop internal budgets for negotiations of sponsored and investigator-initiated clinical trials, ensuring compliance with applicable state and federal laws and regulations.</li>
<li>Lead the development and implementation of study builds in the Clinical Trial Management System (CTMS).</li>
<li>Manage human resource functions, including recruitment, hiring, career development, performance evaluations, disciplinary actions, and day-to-day HR functions.</li>
<li>Ensure good communication and compliance with regulations across various ministries and stakeholders.</li>
</ul>
Essential Skills
<ul>
<li>Bachelor’s degree in Healthcare or related field is required.</li>
<li>A minimum of 7 years of clinical research experience.</li>
<li>At least 5 years of experience in management or supervision of clinical trials.</li>
<li>5 years of experience in clinical research finance.</li>
<li>Proficiency in negotiating contracts and understanding industry budget terms.</li>
<li>Knowledge of accounting and budgeting processes.</li>
<li>Experience with CTMS, particularly Verily/Signal Path or similar systems.</li>
<li>Familiarity with FDA (GCP, ICH guidelines) and other federal, state, and local regulations on human research.</li>
<li>Experience in working with pharmaceutical and FDA agency representatives.</li>
</ul>
Additional Skills &amp; Qualifications
<ul>
<li>Master's degree in Healthcare, Business, or related field is preferred.</li>
<li>Experience in managing data collection, reporting, outcomes, quality improvement, and standards/pathways.</li>
</ul>
Work Environment
This is a hybrid role with a schedule starting around 8 a.m., as long as it is before 9 a.m. The role is remote for four days a week and in-office one day a week at the Anaheim location, with Wednesdays designated as the team day in the office. Initially, more onsite presence is required for training. The team consists of seven staff members, including financial analysts, CTMS specialists, and administrative personnel. The manager will guide and support the team, ensuring tasks are completed accurately and on schedule. The central team covers all Southern California sites, managing a diverse portfolio with a focus on oncology, cardio, rheumatology, and endocrine therapeutic areas. The team handles approximately 130 open trials with 60-70 new studies initiated each year.
Job Type &amp; Location
This is a Contract to Hire position based out of Anaheim, CA.
Pay and Benefits
The pay range for this position is $58.79 - $92.82/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental &amp; vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life &amp; AD&amp;D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in Anaheim,CA.
Application Deadline
This position is anticipated to close on Jan 18, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email <a href="mailto:actalentaccommodation@actalentservices.com" target="_blank">actalentaccommodation@actalentservices.com</a> for other accommodation options.

Manager Clinical Research Finance

<h3>Job Description</h3>
Job DescriptionDescription:
 
The Clinical Study Manager is responsible for the successful execution of clinical trials from protocol conception through to clinical study report. The Clinical Study Manager ensures completion of study deliverables and proactively identifies and resolves clinical project issues. This role is accountable for leading the extended clinical study team and supporting the strategic planning and execution of clinical trials ensuring compliance with regulatory and legal requirements, ensuring high quality execution, clinical trial participant safety and data integrity.
 
Candidates can be hybrid to Norwood, MA or remote on east coast with monthly travel to Norwood, Ma.
 
Primary Responsibilities:
<ul>
<li>Clinical operations leader who drives the successful execution of all operational components of a study, using strong project management, leadership and organizational skills. </li>
<li>Develop comprehensive study timelines and metrics</li>
<li>Develop and manage study budget within financial goals</li>
<li>Management of risk associated with KPI and issue escalation</li>
<li>Prepare and present project briefings, as required; plan, execute, and lead or participate in study-specific meetings</li>
<li>Coordinates and participates in periodic data quality review and may contribute to interpretation of clinical trial results</li>
<li>Coordinates with Data Management, Statistics, Medical and other functions for full life cycle management of clinical trial activities</li>
<li>Identify and assist in selection of external vendors required and the development of vendor specifications. Review and prepare vendor reports related to vendor proposals with recommendations</li>
<li>Assist in the selection and evaluation of study personnel (contract and internal)</li>
<li>Provide or facilitate study-specific training to clinical research staff, and other contract personnel</li>
<li>Manage study-related vendors and serve as the primary point of contact for all contracted vendors (CROs, SMOs, Labs, Meeting Planner, etc)</li>
<li>Identify potential risks and resolve issues with CROs while establishing vendor management plans and reviewing quality metrics</li>
<li>Participate in site and country selection. Review completed feasibility questionnaires to assist with site selection. Develop relationships with investigators and site staff</li>
<li>Prepare and review site study documents: site-specific informed consent, study tools/worksheets, investigator contracts and site payments</li>
<li>Oversee clinical monitoring activities, ensuring compliance with (GCP) and applicable regulations</li>
<li>Participate in site co-monitoring visits as appropriate</li>
<li>Support the design of clinical trial protocols along with the study team and consistent with the clinical development plan</li>
<li>In collaboration with the Clinical Scientist, develop ongoing data review plan to ensure data trend detection and study objectives are met</li>
<li>Prepare study-related documentation; provide input for the design of ICF template, CRFs, monitoring conventions, edit checks, etc.</li>
<li>Prepare and/or review study-related documents including the Site Performance Plan, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, CRF Completion Guidelines and Risk Mitigation Plan</li>
<li>Provide input and support documentation for adverse event safety monitoring while collaborating on FDA and regulatory authorities report submissions</li>
<li>Coordinate with CMC or Clinical Supply to facilitate study drug manufacture, packaging, labeling and distribution</li>
<li>Participate in planning of QA activities and coordinate resolution of audit findings</li>
<li>Ensure audit-ready clinical trial documentation including central clinical files. Review monitoring reports, ensuring quality and resolution of site-related issues</li>
<li>Coordinate and assist regulatory or ethics committee activities planning</li>
<li>Provide oversight to maintain clinical trial master files and ensure appropriate compliance and completeness</li>
<li>For any study CAPA raised perform a root cause analysis, as well as drive all actions to completion, within the expected timeframe</li>
<li>Lead and consistently be present for the Cross-Functional Study Team as well as for internal and external personnel (e.g., Regulatory Affairs, investigators, CROs, vendors, etc.)</li>
<li>May represent Clinical Operations in other cross-functional activities or participate in functional initiatives in support of departmental objectives</li>
<li>This role reports directly to the Senior Director, Clinical Operations.</li>
</ul>
Requirements:
<ul>
<li>Bachelor’s Degree (health, biologic science or related field) required</li>
<li>Minimum of 8 years clinical study management experience in biopharmaceutical industry, including at least 5 years as a clinical study lead/project manager, required</li>
<li>Prior experience managing contracted resources/CRO required</li>
<li>Experience managing metabolic clinical programs through phase 1-4, experience with obesity trials would be ideal</li>
<li>Site monitoring and clinical data review experience highly preferred</li>
<li>Clinical quality compliance experience highly preferred</li>
<li>Advanced knowledge of GCP and current knowledge of US, EU and UK regulations</li>
<li>Knowledge of ICH and other country regulatory requirements is preferred</li>
<li>Excellent communication, organizational, problem-solving, conflict resolution, leadership and team-building skills required</li>
</ul>
Corbus Culture:
 
Corbus is a close-knit global team of high-achieving, innovative, creative and, above all else, passionate employees. We hire for personality as well as for skill. At Corbus, we take pride in our “family” atmosphere where each person’s contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here.
 
About Corbus:
 
Corbus is an oncology and obesity company committed to helping people defeat serious illness by bringing innovative scientific approaches to well understood biological pathways. Corbus’ internal development pipeline includes CRB-701, a next generation antibody drug conjugate (ADC) that targets the expression of Nectin 4-on cancer cells to release a cytotoxic payload and CRB-601, and anti-integrin monoclonal antibody which blocks the activation of TGFß expressed on cancer cells. Additionally, we are developing a cannabinoid receptor-1 (CB-1) inverse agonist as potential treatment for obesity. Corbus is headquarters in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook.
Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer

Clinical Study Manager

<h3>Job Description</h3>
Job Description
Orso Health is a leading organization in clinical research, dedicated to advancing healthcare through innovative studies. We are committed to excellence in research and invite you to be part of our dynamic team. California and the Arizona market. Known for our high standards of excellence, we are committed to providing compassionate, patient-centered care for both pediatric and adult patients. Our dedicated team strives to improve lives through the expert diagnosis and treatment of a wide range of allergy and asthma conditions. We are looking for high-energy, kind, and collaborative individuals who are eager to grow personally and professionally to join our team.  
Position Summary
We are seeking an experienced Clinical Research Site Manager to lead operations across multiple clinical research sites, with primary responsibility for our La Jolla, CA location. This role provides leadership to Clinical Research Coordinators at more than one site and ensures consistent, high-quality, compliant execution of clinical studies. The Site Manager will oversee staff development, operational efficiency, regulatory compliance, and data quality, while ensuring data integrity and high standards of research conduct across all assigned sites. 
This position requires travel, with occasional support at our Los Angeles clinic sites in Torrance, Long Beach, Scottsdale AZ. This role is an exempt, full-time role, working standard business hours with flexibility for early or late visits as needed for study conduct. 40 hours per week, Monday through Friday, onsite in our La Jolla Clinic.
Key Responsibilities
Multi-Site Leadership &amp; Operational Oversight:
<ul>
<li>Provide operational leadership and management across multiple clinical research sites, ensuring consistency in workflow, quality, and compliance. </li>
</ul>
<ul>
<li>Hire, onboard, train, and evaluate Clinical Research Coordinators and support staff across sites. </li>
</ul>
<ul>
<li>Monitor staffing levels and coordinate resource allocation across all active trials and locations. </li>
</ul>
<ul>
<li>Oversee day-to-day clinical operations, visit scheduling, and subject care across sites. </li>
</ul>
<ul>
<li>Ensure research staff at all locations follow protocols, SOPs, GCP, and institutional policies. </li>
</ul>
<ul>
<li>Maintain and document training standards across all assigned sites. </li>
</ul>
<ul>
<li>Contribute to patient recruitment and retention strategies across the site network. </li>
</ul>
<ul>
<li>Foster a culture of teamwork, accountability and "Quality Without Compromise" </li>
</ul>
Protocol Compliance &amp; Site Execution:
<ul>
<li>Supervise the implementation and adherence to study protocols across multiple sites. </li>
</ul>
<ul>
<li>Ensure timely and accurate source documentation and data entry at each location. </li>
</ul>
<ul>
<li>Ensure all sites meet electronic regulatory requirements and maintain audit-ready regulatory documentation. </li>
</ul>
<ul>
<li>Support internal and external audits across all assigned research sites. </li>
</ul>
Data Quality, Monitoring, &amp; Documentation:
<ul>
<li>Monitor data quality across locations to ensure accuracy, completeness, consistency, and data integrity. </li>
</ul>
<ul>
<li>Conduct remote or onsite monitoring visits at various sites to review source documents, CRFs, and regulatory materials. </li>
</ul>
<ul>
<li>Maintain data integrity and research conduct through ongoing oversight and timely resolution of data discrepancies. </li>
</ul>
<ul>
<li>Coordinate and support external monitoring visits across locations, including preparation, communication, and follow-up. </li>
</ul>
<ul>
<li>Document monitoring activities in compliance with SOPs, GCP, and ICH guidelines. </li>
</ul>
<ul>
<li>Implement and support quality assurance initiatives that enhance operational consistency and research conduct across all sites. </li>
</ul>
Regulatory, Audit, &amp; Quality Assurance Support:
<ul>
<li>Assist in audit preparation and regulatory inspections across multiple sites. </li>
</ul>
<ul>
<li>Maintain compliant regulatory files and electronic systems for each assigned location. </li>
</ul>
<ul>
<li>Identify operational or documentation gaps across sites and support corrective and preventive action plans. </li>
</ul>
<ul>
<li>
<ul>
<li>Perform additional responsibilities as needed to support multi-site clinical operations. </li>
</ul>
</li>
</ul>
Skills &amp; Qualifications
<ul>
<li>Education: Bachelor's degree in life sciences, healthcare, or related field.</li>
<li>Experience:
<ul>
<li>Minimum of 5 years of experience in clinical research, preferably involving multi-site management, monitoring, or data oversight. </li>
</ul>
<ul>
<li>Prior supervisory or team leadership experience strongly preferred. </li>
</ul>
<ul>
<li>Strong working knowledge of FDA regulations, ICH-GCP, and clinical trial operations </li>
</ul>
</li>
<li>Skills &amp; Abilities:
<ul>
<li>Strong understanding of GCP, ICH guidelines, and end-to-end clinical trial operations across multiple sites. </li>
</ul>
<ul>
<li>Excellent attention to detail and organizational skills, particularly in multi-site environments. </li>
</ul>
<ul>
<li>Strong communication skills to effectively support and coordinate cross-site teams. </li>
</ul>
<ul>
<li>Proficiency with CTMS, EDC platforms, electronic regulatory systems, and Microsoft Office Suite. </li>
</ul>
<ul>
<li>Analytical mindset with strong problem-solving capabilities. </li>
</ul>
<ul>
<li>Ability to manage priorities effectively across multiple locations. </li>
</ul>
<ul>
<li>Commitment to quality, data integrity, ethical research conduct, and regulatory compliance. </li>
</ul>
<ul>
<li>Core Values and Culture: The Clinical Research Manager is expected to embody our organization's commitment to integrity, quality, collaboration, and continuous improvement. We value leaders who promote teamwork, foster innovation, and ensure excellence in research execution. </li>
</ul>
</li>
</ul>
Compensation
The annual salary range for this position is $85k - $105k. The actual compensation for this role will be determined by a variety of factors, including but not limited to the candidate's skills, education, and experience.

Physical Requirements
Ability to stand, walk, and move throughout the clinic, if applicable, for extended periods; occasionally lift objects up to 25 lbs., bend, stoop, or reach as needed. Frequent use of hands and fingers for patient care and equipment operation. Must have normal (or corrected) vision and hearing and be able to respond quickly in a fast-paced clinical environment, if applicable.
What We Offer
<ul>
<li>Competitive salary and benefits package, including medical, dental &amp; vision insurance, 401(k) retirement plan with employer matching, and professional development opportunities
<ul>
<li>In addition, we offer paid time Off (PTO), sick time, floating holiday and holiday pay </li>
</ul>
</li>
<li>Opportunity to shape the future of cutting-edge clinical research in beautiful San Diego (and across our expanding network)</li>
<li>An opportunity to play an active role in medical advancement</li>
</ul>
If this role excites you, please submit your resume and a cover letter outlining your relevant experience and why you're passionate about joining our team. We look forward to hearing from enthusiastic candidates ready to drive our success!
California Consumer Privacy Act (CCPA) Notice Orso Health ("OH") complies with the California Consumer Privacy Act ("CCPA"). Personal information provided in the job application process will be collected, used, and retained in accordance with applicable privacy laws. Candidates may request additional information regarding the categories of personal information collected and the purposes for which it is used during the hiring process.

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