<h3>Job Description</h3>
Job Description
Job Title: Clinical Trial Manager
Job Location: Boston, MA, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
The Organization What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. Our Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA- and protein-based programs for the potential treatment of neuromuscular and ocular diseases, among others. Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1. We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families. The Perfect Addition to Our Team You are excited about the opportunity to spearhead clinical trial activities and support the continued growth of our clinical operations function here at Entrada. You are well organized and like to share best practices in clinical operations. You enjoy a fast-paced environment and juggling competing priorities and are willing to jump in and help wherever it is needed. You follow up and follow through, efficiently connecting problems with solutions. You work successfully in a team environment and have strong interpersonal skills, in order to effectively build working relationships inside and outside of the company. The Opportunity This individual will lead in the day-to-day operations, planning, set-up, execution, and closeout of assigned clinical trials. They will support and oversee the planning and management of the operational aspects, including CRO and vendor oversight, to achieve project milestones and clinical study timelines in alignment with company goals and in compliance with local, ICH, GCP, and company policies and procedures. Responsibilities 
<ul>
<li>Ownership of all operational aspects of designated clinical trial, including CRO and vendor management.</li>
<li>Support and manage various study activities, including vendor evaluation and selection, country and site selection, informed consent development and maintenance, eCRF design and implementation, protocols, study plans and manuals, IBs, CSRs</li>
<li>Proactively identify and support resolution/escalation of trial conduct-related issues.</li>
<li>Lead or support cross-functional trial teams, including collaborating with internal team members and external vendors for the planning and execution of clinical trials, through closeout.</li>
<li>Provide regular up-to-date trial information and regular updates on trial progress/performance to internal stakeholders (enrollment, eligibility, protocol deviations, AE reporting etc.).</li>
<li>Oversee clinical monitoring from site qualification to site closure visits to assure integrity of clinical data with respect to accuracy, accountability and documentation through review of case report forms, source documents, and medical records.</li>
<li>Support the review/cleaning and reconciliation of all clinical data, including EDC, PROs, and 3rd party labs to support timely database lock and the accurate analysis of clinical data.</li>
<li>Partner with relevant stakeholders to develop and implement appropriate study-specific training to all relevant study-related personnel (internal, CRO, Site staff, and other relevant 3rd parties).</li>
<li>Support development of department documentation, such as SOPs.</li>
<li>Help develop, organize, and maintain study budgets, working with business operations to ensure accurate forecasting.</li>
<li>Support monitoring activities and visit clinical study sites as needed. </li>
</ul>
The Necessities At Entrada, our passion for science, our devotion to patients and our values drives our behavior: 
<ul>
<li>Humanity - We genuinely care about patients and about one another.</li>
<li>Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.</li>
<li>Creativity - We are creative problem solvers.</li>
<li>Collaboration - We are more than the sum of our parts.</li>
<li>Curiosity - We have a growth mindset and push conventional thought and theory. </li>
</ul>
To thrive on our team, you will need to come with: 
<ul>
<li>BA/BS degree with 7 + years of combined experience supporting and independently managing clinical trial activities.</li>
<li>Strong knowledge of ICH/GCP and regulatory requirements, with a strong preference for experience with EU-CTR. </li>
<li>Strong experience in the drug development process, including trial design, trial planning and management, and CRO and vendor oversight.</li>
<li>Excellent verbal and written communication skills.</li>
<li>Proven ability to work effectively across functions.</li>
<li>Ability to travel approximately 20% of the time, as determined by the needs of the business.</li>
<li>This is a US based remote position, with preference given to local New England based candidates. This role will require minimum monthly or quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA. </li>
</ul>
The Perks By becoming a team member here at Entrada, you’ll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance. We value work life balance, you'll benefit from discretionary time off, paternity leave, and an excellent 401(k) package. We also offer a generous transportation stipend to commute as you wish. Our location in the vibrant and growing Seaport District is close to all the best that the city of Boston has to offer. Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law. Third Party Staffing Agencies Entrada does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Entrada from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Entrada and do not obligate Entrada to pay fees if we hire from those resumes. Privacy Statement Entrada Therapeutics, Inc. (the “Entrada,” “we,” “us,” or “our”) respects your privacy and we want you to be familiar with how we collect, use, share, or otherwise process, your Personal Information. Please reference our privacy statement here to understand how and when your data is being used. 
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Clinical Trial Manager

<h3>Job Description</h3>
Job Description
We are looking for a Clinical Trial Manager II to join our team!
APPLY DIRECTLY at <a href="https://cpcclinicalresearch.org/careers/" target="_blank">https://cpcclinicalresearch.org/careers/</a> 
Are you well organized and 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!
Clinical Trial Manager II serves as the primary point of contact for clinical trials site operations.
In this position you will:
<ul>
<li>Serve as the secondary contact to address site questions when the site Clinical Research Associate (CRA) or Research Assistant (RA) is unavailable.</li>
<li>Ensure CPC SOPs, Good Clinical Practice guidelines and applicable federal, state and local regulations are being followed.</li>
<li>Review monitoring visit reports and follow-up letters for Site Endpoint Evaluation Visits, Site Evaluation Visits, Site Initiation Visits, Routine Monitoring Visits, and Close-out Visits and Addendums and work with CRAs to clarify issues and finalize reports and follow-up letters.</li>
<li>Review site specific Informed Consent Forms (ICFs) to address site specific changes and escalate to internal or external parties for approval, as needed.</li>
<li>Provide the Project Manager with metrics and updates on sites including but not limited to: study related site enrollment, site activations, protocol deviations, monitoring reports and follow-up letters status.</li>
<li>Assure proper maintenance of site required records for monitoring activities and required regulatory documents per CPC requirements.</li>
<li>Create and/or review study-specific monitoring visit reports and, follow-up letter templates, and project specific site materials including Monitoring Plans, ICF templates, Study Procedure Manual, source document and site newsletter.</li>
<li>Work with CRAs, RAs and new Clinical Trial Managers on overall site management including identification, escalation and resolution of site related compliance issues.</li>
<li>Oversee Investigational Product (IP) release and once IP release has occurred, work with the RAs to collect all new or expiring Investigator regulatory documents.</li>
<li>Oversee and approve site activations and IP release.</li>
<li>Participate in project-related and other departmental/CPC meetings as required.</li>
<li>Oversee the selection of qualified sites and Investigators for participation in research protocols.</li>
<li>Work with sites to negotiate the study site budget. Oversee tracking, request and work with the Finance department on processing study site payments.</li>
<li>Oversee project specific training of site staff.</li>
<li>Train new Clinical Trial Managers on reviewing and processing monitoring visit reports and follow-up letters, completing metrics and updates, tracking site specific documents, and creating project specific documents.</li>
<li>Attend project team meetings as necessary and provide CRAs with updated study information to support their monitoring activities.</li>
<li>Work closely with other team members to ensure timely resolution of site issues.</li>
<li>Conduct drug tracking and disposition as required by project.</li>
<li>Overseeing remote monitoring.</li>
<li>Ensure Clinical Trial Management System (CTMS) remains up to date with all site trial activities including but not limited to site communications, document status, monitoring visits, protocol deviations.</li>
<li>Conduct site monitoring visits or co-monitoring visits, as needed.</li>
<li>Additional duties as required.</li>
</ul>
Here’s what you will need to bring to the table:
<ul>
<li>Nursing or bachelor’s degree preferred.</li>
<li>A minimum of 3 years of experience in clinical research setting required, experience in monitoring and clinical trial management preferred.</li>
<li>Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.</li>
<li>Thorough understanding of the drug development process.</li>
<li>Proficiency in Microsoft Office Suite (Excel, Word, Outlook, PowerPoint).</li>
<li>Experience with electronic data capture systems.</li>
<li>Excellent interpersonal communication skills, organizational skills and a great attention to detail. Ability to organize and instruct staff, while promoting group effort and achievement.</li>
<li>Ability to carry out multiple tasks simultaneously.</li>
<li>Ability to complete tasks in an accurate and timely manner.</li>
<li>Ability to manage conflicts and resolve problems effectively.</li>
<li>Ability to discern priorities with minimal direction to accomplish day-to-day tasks.</li>
<li>Willingness to travel up to 25% of the time.</li>
</ul>
Note: Viable applicants will be required to pass a background and education verification check.
Targeted Compensation: $72,000 - $88,000 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 Trial Manager II - remote

<h3>Job Description</h3>
Job Description
We are looking for a Clinical Trial Manager II to join our team!
APPLY DIRECTLY at <a href="https://cpcclinicalresearch.org/careers/" target="_blank">https://cpcclinicalresearch.org/careers/</a> 
Are you well organized and 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!
Clinical Trial Manager II serves as the primary point of contact for clinical trials site operations.
In this position you will:
<ul>
<li>Serve as the secondary contact to address site questions when the site Clinical Research Associate (CRA) or Research Assistant (RA) is unavailable.</li>
<li>Ensure CPC SOPs, Good Clinical Practice guidelines and applicable federal, state and local regulations are being followed.</li>
<li>Review monitoring visit reports and follow-up letters for Site Endpoint Evaluation Visits, Site Evaluation Visits, Site Initiation Visits, Routine Monitoring Visits, and Close-out Visits and Addendums and work with CRAs to clarify issues and finalize reports and follow-up letters.</li>
<li>Review site specific Informed Consent Forms (ICFs) to address site specific changes and escalate to internal or external parties for approval, as needed.</li>
<li>Provide the Project Manager with metrics and updates on sites including but not limited to: study related site enrollment, site activations, protocol deviations, monitoring reports and follow-up letters status.</li>
<li>Assure proper maintenance of site required records for monitoring activities and required regulatory documents per CPC requirements.</li>
<li>Create and/or review study-specific monitoring visit reports and, follow-up letter templates, and project specific site materials including Monitoring Plans, ICF templates, Study Procedure Manual, source document and site newsletter.</li>
<li>Work with CRAs, RAs and new Clinical Trial Managers on overall site management including identification, escalation and resolution of site related compliance issues.</li>
<li>Oversee Investigational Product (IP) release and once IP release has occurred, work with the RAs to collect all new or expiring Investigator regulatory documents.</li>
<li>Oversee and approve site activations and IP release.</li>
<li>Participate in project-related and other departmental/CPC meetings as required.</li>
<li>Oversee the selection of qualified sites and Investigators for participation in research protocols.</li>
<li>Work with sites to negotiate the study site budget. Oversee tracking, request and work with the Finance department on processing study site payments.</li>
<li>Oversee project specific training of site staff.</li>
<li>Train new Clinical Trial Managers on reviewing and processing monitoring visit reports and follow-up letters, completing metrics and updates, tracking site specific documents, and creating project specific documents.</li>
<li>Attend project team meetings as necessary and provide CRAs with updated study information to support their monitoring activities.</li>
<li>Work closely with other team members to ensure timely resolution of site issues.</li>
<li>Conduct drug tracking and disposition as required by project.</li>
<li>Overseeing remote monitoring.</li>
<li>Ensure Clinical Trial Management System (CTMS) remains up to date with all site trial activities including but not limited to site communications, document status, monitoring visits, protocol deviations.</li>
<li>Conduct site monitoring visits or co-monitoring visits, as needed.</li>
<li>Additional duties as required.</li>
</ul>
Here’s what you will need to bring to the table:
<ul>
<li>Nursing or bachelor’s degree preferred.</li>
<li>A minimum of 3 years of experience in clinical research setting required, experience in monitoring and clinical trial management preferred.</li>
<li>Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.</li>
<li>Thorough understanding of the drug development process.</li>
<li>Proficiency in Microsoft Office Suite (Excel, Word, Outlook, PowerPoint).</li>
<li>Experience with electronic data capture systems.</li>
<li>Excellent interpersonal communication skills, organizational skills and a great attention to detail. Ability to organize and instruct staff, while promoting group effort and achievement.</li>
<li>Ability to carry out multiple tasks simultaneously.</li>
<li>Ability to complete tasks in an accurate and timely manner.</li>
<li>Ability to manage conflicts and resolve problems effectively.</li>
<li>Ability to discern priorities with minimal direction to accomplish day-to-day tasks.</li>
<li>Willingness to travel up to 25% of the time.</li>
</ul>
Note: Viable applicants will be required to pass a background and education verification check.
Targeted Compensation: $72,000 - $88,000 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) * In-suite exercise and relaxation room * 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* In-suite exercise and relaxation room\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>.

<h3>Job Description</h3>
Job DescriptionSalary: 
Shoulder Innovations is a venture-backed medical device startup that is revolutionizing shoulder replacements. Led by a seasoned team with over a century of orthopedic expertise, weve developed a disruptive shoulder replacement system and secured substantial funding to drive rapid growth. 
 Were seeking entrepreneurial talent to join us on this exciting journey. Our culture is built on: 
<ul>
<li>People First: Authentically human.</li>
<li>One Team: Empowered and aligned.</li>
<li>Innovation: Bold, creative, and daring.</li>
<li>Growth Mindset: Always curious.</li>
</ul>
Ready to make an impact in orthopedics? Lets grow together! 
We are seeking a Clinical Trial Manager who wants to use their knowledge to help grow our venture capital-backed business. Someone who is experienced in clinical trials, registry, very organized, and a strong self-starter would be a perfect fit. 
As a Clinical Trial Manager, some of your job duties will include:
<ul>
<li>Manage the planning, execution and monitoring of clinical trials to ensue adherence to timelines</li>
<li>Develop and maintain trial documentation including protocols, informed consent forms, and study reports.</li>
<li>Ensure clinical studies are compliant with ICH/GCP, FDA regulations and other regulations, as appropriate, throughout the trial process</li>
<li>Oversees data collection processes to ensure accuracy and integrity of trial data</li>
<li>Participates in site selection, monitoring and close-out visits as necessary</li>
<li>Provide training and support to site staff on study protocols and procedures</li>
<li>Analyze trial data and prepare reports for stakeholders</li>
<li>Participate in continuous improvement activities</li>
</ul>
To be successful as a Clinical Trial Manager, you will have the following experiences and skills
<ul>
<li>Minimum Bachelors degree in scientific discipline and 7+ years of related work experience or an equivalent combination of education and work experience</li>
<li>Minimum 2+ years of Independent Clinical Trial Management preferred</li>
<li>Proven experience with registries preferred</li>
<li>Proven experience with shoulder arthroplasty or orthopedics preferred</li>
<li>Familiarity with clinical development standards and regulatory requirements (GCP, FDA)</li>
<li>Strong knowledge of clinical trials management principles and practices</li>
<li>Proficiency in data collection methodologies and data management</li>
<li>Detail-orientated with the ability to multi-task</li>
<li>Exceptional drive, work ethic and initiative</li>
<li>Energetic and enthusiastic personality who thrives on diversity and challenge in a role</li>
<li>Must be able to work collaboratively and operate in a fast-paced environment</li>
<li>Strong working knowledge of MS Office</li>
<li>Excellent analytical and problem-solving skills</li>
<li>Proficient written and verbal communication skills</li>
</ul>
If you believe that you are a perfect fit to join our team as a Clinical Trial Manager, please consider applying today. To learn more about what Shoulder Innovations does, please visit us at <a href="http://www.shoulderinnovations.com" target="_blank">www.shoulderinnovations.com</a>.
 remote work

<h3>Job Description</h3>
Job DescriptionSalary: $72,000 - $88,000 
We are looking for a Clinical Trial Manager II to join our team!
Are you well organized and 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!
Clinical Trial Manager II serves as the primary point of contact for clinical trials site operations.
 
Remote candidates are welcome to apply.
In this position you will:
 
<ul>
<li>Serve as the secondary contact to address site questions when the site Clinical Research Associate (CRA) or Research Assistant (RA) is unavailable.</li>
<li>Ensure CPC SOPs, Good Clinical Practice guidelines and applicable federal, state and local regulations are being followed.</li>
<li>Review monitoring visit reports and follow-up letters for Site Endpoint Evaluation Visits, Site Evaluation Visits, Site Initiation Visits, Routine Monitoring Visits, and Close-out Visits and Addendums and work with CRAs to clarify issues and finalize reports and follow-up letters.</li>
<li>Review site specific Informed Consent Forms (ICFs) to address site specific changes and escalate to internal or external parties for approval, as needed.</li>
<li>Provide the Project Manager with metrics and updates on sites including but not limited to: study related site enrollment, site activations, protocol deviations, monitoring reports and follow-up letters status.</li>
<li>Assure proper maintenance of site required records for monitoring activities and required regulatory documents per CPC requirements.</li>
<li>Create and/or review study-specific monitoring visit reports and, follow-up letter templates, and project specific site materials including Monitoring Plans, ICF templates, Study Procedure Manual, source document and site newsletter.</li>
<li>Work with CRAs, RAs and new Clinical Trial Managers on overall site management including identification, escalation and resolution of site related compliance issues.</li>
<li>Oversee Investigational Product (IP) release and once IP release has occurred, work with the RAs to collect all new or expiring Investigator regulatory documents.</li>
<li>Oversee and approve site activations and IP release.</li>
<li>Participate in project-related and other departmental/CPC meetings as required.</li>
<li>Oversee the selection of qualified sites and Investigators for participation in research protocols.</li>
<li>Work with sites to negotiate the study site budget. Oversee tracking, request and work with the Finance department on processing study site payments.</li>
<li>Oversee project specific training of site staff.</li>
<li>Train new Clinical Trial Managers on reviewing and processing monitoring visit reports and follow-up letters, completing metrics and updates, tracking site specific documents, and creating project specific documents.</li>
<li>Attend project team meetings as necessary and provide CRAs with updated study information to support their monitoring and SEEV activities.</li>
<li>Work closely with other team members to ensure timely resolution of site issues.</li>
<li>Conduct drug tracking and disposition as required by project.</li>
<li>Overseeing remote monitoring.</li>
<li>Ensure Clinical Trial Management System (CTMS) remains up to date with all site trial activities including but not limited to site communications, document status, monitoring visits, protocol deviations.</li>
<li>Conduct site monitoring visits or co-monitoring visits, as needed.</li>
</ul>
 
Heres what you will need to bring to the table:
 
<ul>
<li>Nursing or bachelors degree preferred.</li>
<li>A minimum of 3 years of experience in clinical research setting required.</li>
<li>Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.</li>
<li>Thorough understanding of the drug development process.</li>
<li>Proficiency in Microsoft Office Suite (Excel, Word, Outlook, PowerPoint).</li>
<li>Experience with electronic data capture systems.</li>
<li>Excellent interpersonal communication skills, organizational skills and a great attention to detail. Ability to organize and instruct staff, while promoting group effort and achievement.</li>
<li>Ability to carry out multiple tasks simultaneously.</li>
<li>Ability to complete tasks in an accurate and timely manner.</li>
<li>Ability to manage conflicts and resolve problems effectively.</li>
<li>Ability to discern priorities with minimal direction to accomplish day-to-day tasks.</li>
<li>Willingness to travel up to 25% of the time.</li>
</ul>
 
Note:Viable applicants will be required to pass a background and education verification check.
Targeted Compensation:$72,000 - $88,000 annually
 
Deadline to Apply: August 1, 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:
 
<ul>
<li>Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)</li>
<li>Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)</li>
<li>11 paid holidays</li>
<li>15 - 25 vacation days based on years of service</li>
<li>Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)</li>
<li>In-suite exercise and relaxation room</li>
<li>Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)</li>
<li>Flexible and remote work schedules</li>
</ul>
 
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

Clinical Trial Manager II

<h3>Job Description</h3>
Job Description
Job Description:
We are seeking a highly motivated and qualified individual to join our Clinical Department as a Clinical Trial Manager (CTM) and work as part of a team to drive success. Ideal candidates will be self-motivated, independent, committed to the generation of high-quality data within a fast-paced and innovative research team. The CMT will support ongoing RNA-based drug discovery projects in several therapeutic areas. 
The Clinical Trial Manager (CTM) is responsible for supporting the effective planning and conduct of one or more ADARx Pharmaceuticals clinical trials in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and applicable regulatory requirements.
Essential Responsibilities:
<ul>
<li>Communicate directly with trial site staff and investigators to support the relationship between the sponsor and site. Depending on experience, you may co-monitor or participate in Sponsor oversight visits.</li>
<li>Plan and participate in Monitor and Investigator Meetings.</li>
<li>Generate and utilizes metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to Clinical Team Members as appropriate.</li>
<li>Maintain and report metrics for trial tracking and clinical site performance, including patient recruitment and retention.</li>
<li>May perform clinical data review of patient profiles, data listings and summary tables, including query generation.</li>
<li>Develop and/or provide input to trial plans, such as Project Management Plan, Enrollment Plan, Monitoring Plan, Protocol Deviation Plan, etc.</li>
<li>Develop or provide input to patient information/consent, eCRF forms and completion guidelines, site instructions for specimen collections, study drug order forms, etc.</li>
<li>Review and/or approve of IP release packages.</li>
<li>Review monitoring reports for compliance with study protocols and GCP.</li>
<li>Review protocol deviations and data listings.</li>
<li>Support safety reporting.</li>
<li>Support the management, tracking and oversight of clinical site budgets/payments in relation to conduct of a clinical trial.</li>
<li>Manage IRB/IEC and regulatory submissions, as needed.</li>
<li>CRO management and oversight.</li>
<li>Establish vendor management plans and review quality metrics.</li>
<li>May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with Clinical Team Members.</li>
<li>Contribute to the preparation of research reports and presentations for internal project teams, leadership team, and external audience.</li>
<li>Establish and maintain excellent working relationships with critical collaborative partners throughout the company.</li>
<li>Maintain all corporate standards for lab safety and hazardous material management.</li>
<li>Other duties as assigned.</li>
</ul>
Essential Physical Characteristics:
Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis.
On-Site Protocol:
Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
Qualifications:
<ul>
<li>BS/MS in life and health sciences (biology, pharmacology, pharmaceutical sciences or equivalent).</li>
<li>5+ years of combined managing/monitoring Phase 1, 2, or 3 clinical trials.</li>
<li>Ability to work across global time zones (including EU, APAC).</li>
<li>Experience in performing clinical site monitoring visits, including remote visits.</li>
<li>Experience in CRO/Vendor management (domestic/international) monitoring of budget scope.</li>
<li>Comprehensive knowledge of ICH, GCP, IRB/IEC, and local regulatory authority requirements.</li>
<li>Proficiency working with Microsoft Office Suite Products, EDC, IRT.</li>
<li>Ability to travel domestically and internationally if necessary.</li>
</ul>
Preferred Qualifications:
<ul>
<li>Global clinical trial experience preferred.</li>
</ul>
Required Key Attributes:
<ul>
<li>Must be able to work independently with supervision as needed.</li>
<li>Excellent written and verbal communication skills and effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role.</li>
<li>Strong problem-solving skills and a proactive attitude towards exploring new approaches.</li>
<li>Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders.</li>
<li>Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.</li>
<li>Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment.</li>
</ul>
Compensation:
<ul>
<li>This is a full-time position, Monday-Friday, occasional overtime.</li>
<li>Pay is commensurate with experience.</li>
<li>Equity-based compensation</li>
<li>Performance-based bonuses</li>
<li>401(k) with Company Match</li>
<li>Medical, Dental, Vision</li>
<li>Flexible Spending Account</li>
<li>Life Insurance</li>
<li>Employee Assistance Program</li>
<li>Employee Discounts </li>
<li>Gym Membership</li>
<li>Paid Vacation</li>
<li>Paid Holidays</li>
<li>Paid Sick, Jury Duty, Bereavement</li>
</ul>
Work Authorization:
<ul>
<li>United States (Required)</li>
<li>Background Check</li>
<li>As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check.</li>
</ul>
Company Overview:
ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system.
ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of renowned VC firms.
ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

Disclosure Statement:
<ul>
<li>The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.</li>
<li>Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.</li>
<li>The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law.</li>
<li>Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses.</li>
<li>Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.</li>
</ul>

186 Remote Clinical Trial Manager Jobs