<h3>Job Description</h3>
Job DescriptionPOSITION SUMMARY:The Clinical Trial Manager will be responsible for managing all aspects of clinical trials from start-up through close-out. The Clinical Trial Manager should have experience in managing all aspects of the trials independently, and is expected to provide functional expertise to ensure that study timelines, costs and quality metrics are met and the study is conducted in compliance with the study protocol, SOPs, and applicable regulatory requirements.PRIMARY RESPONSIBILITIES:
<ul>
<li>Manage the execution and conduct of all aspects of very complex clinical studies to ensure that timelines, cost, and quality metrics are met</li>
<li>Responsible for selection of vendors/CROs and provide effective ongoing management to vendors/CROs working on the project to ensure compliance and execution of project deliverables within the approved budget, study timeline, and study protocol. Works closely with investigative site personnel, CROs, and other study vendors</li>
<li>Manage study contracting, budget, forecasting, accruals and payment process for all clinical trial vendors including investigational sites</li>
<li>Lead study-related activities such as protocol and informed consent preparation, investigator selection, study training material development and delivery, monitoring plans development and execution, CRFs, design and completion, TMF maintenance, protocol amendment and clinical report preparation, as required</li>
<li>Collaborate with Clinical Data Management group to ensure correct CRFs content is collected, prepare comprehensive completion guidelines, and design effective data listings and study reports</li>
<li>Train CROs, vendors, investigators and study coordinators on implementation of study protocol</li>
<li>Hire, train and oversee Clinical trial staff, and serve as a resource for others within the company for clinical trials management expertise</li>
<li>Monitor and track clinical trial progress and provide status update to stakeholders</li>
<li>Support prospective sample testing for studies where Natera functions as a central testing facility</li>
<li>Partner with other research and development groups to create a culture of mutual respect and focus on delivery of high-quality project results</li>
<li>Hire, train and oversee Clinical trial staff, and mentor junior clinical operations staff.</li>
<li>Develop Clinical Department SOPs and participate in audits as needed</li>
<li>This role works with PHI on a regular basis both in paper and electronic form and have an access to various technologies to access PHI (paper and electronic) in order to perform the job. </li>
<li>Employee must provide records of current training or complete training relating to HIPAA/PHI privacy, Human Subjects Protection, and GCP training.</li>
<li>Must maintain a current status on Natera training requirements including General Policies and Procedure Compliance and security training.</li>
</ul>
QUALIFICATIONS:
<ul>
<li>Bachelor's degree in life sciences, or other relevant discipline required, Advanced degree preferred.</li>
<li>8 years of clinical research experience, including at least 4 years of experience in managing clinical trials as a leading role.</li>
<li>4-7 years of experience in supporting clinical trials in a regulated environment .</li>
<li>Experience in managing CROs is preferred.</li>
</ul>
KNOWLEDGE, SKILLS, AND ABILITIES:
<ul>
<li>Knowledge and understanding of Clinical Trial SOPs, FDA Regulations, and ICH-GCPs governing the conduct of clinical trials</li>
<li>Demonstrated analytical skills and ability to identify problems and solutions independently</li>
<li>Ability to collaborate with the study team, cross functional team members and external collaborators</li>
<li>Proficiency in MS Word, Excel and PowerPoint</li>
<li>Good organization and planning skills</li>
<li>Strong interpersonal skills and communication skills (both written and oral)</li>
<li>Strong leadership skills, self-motivated, adaptable to a dynamic and fast paced environment</li>
<li>Must have excellent organizational and time management skills.</li>
<li>Ability to prioritize and handle multiple tasks and projects in a fast-paced environment</li>
</ul>
The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years &amp; depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.Remote USA$135,300—$169,200 USD
OUR OPPORTUNITY
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you'll work hard and grow quickly. Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!
For more information, visit <a href="http://www.natera.com" target="_blank">www.natera.com</a>.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents. 
Link: <a href="https://www.natera.com/notice-of-data-collection-california-residents/" target="_blank">https://www.natera.com/notice-of-data-collection-california-residents/</a>
Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information: - BBB announcement on job scams - FBI Cyber Crime resource page

Clinical Trial Manager

<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: July 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
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?&nbsp;MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit <a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on LinkedIn.
Responsibilities:
<ul>
<li>Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client.</li>
<li>Demonstrated ability to lead/ manage multiple individuals and/or groups.</li>
<li>Cross-functionally collaborates and coordinates Transparency deliverables ensuring that timelines and milestones remain on-track and within target.</li>
<li>Strategically assesses resource utilization and forecasting to ensure companywide goals are met</li>
<li>Effectively communicates complex strategic concepts with ability to tailor message to targeted audience.</li>
<li>Demonstrate thought leadership with customers by developing and presenting client industry trends, benchmarking, and other pertinent information. May participate in industry events for this purpose.</li>
<li>Demonstrated ability to lead / manage multiple individuals and/or groups in a global environment.</li>
<li>Directs strategic planning and proactively prepares contingency plans to address unforeseen challenges within group, and cross functionally to ensure uninterrupted delivery and maintain compliance.</li>
<li>Ability to facilitate positive group morale and productivity by appropriately including others in decisions/plans.</li>
<li>Manages staff, makes decisions and advises others on complex problems; understands intra- and inter-departmental implications of decisions and can develop strategic solutions with minimal input.</li>
<li>Direct, manage, and oversee the daily activities and workload of the transparency, PLS, and redaction teams.</li>
<li>Proactively identifies areas for improvement before issues arise and provides strategic proposal/resolution for consideration.</li>
<li>Develops and leads teams with diverse experience and skill sets to achieve intra and inter departmental goals.&nbsp;</li>
</ul>
Requirements:&nbsp;
<ul>
<li>Graduate degree in scientific, medical, clinical discipline or related field, or related experience, Masters preferred.</li>
<li>Minimum of 6 years’ experience in clinical trial transparency, disclosure, or medical writing role</li>
<li>At least 5 years of experience in a CRO environment.</li>
<li>Demonstrated managerial skills and experience preferred.</li>
<li>High level knowledge of drug development process, clinical development, and operations, with a strong understanding of regulatory guidelines.</li>
<li>Excellent scientific writing skills.</li>
<li>Excellent analytical, organizational, and problem-solving skills.</li>
<li>Proficiency with MS Office applications.</li>
<li>Strong communication and presentation skills.</li>
<li>Knowledge of ISO 9001, ISO 27001, 21 CFR Part 11, FDA, and GCP requirements</li>
<li>Understanding of CROs and scientific &amp; clinical data/ terminology, &amp; the drug development process.</li>
</ul>
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2vzTw7PPAe

Senior Manager, Clinical Trial Transparency & Disclosure (Remote)

<h3>Job Description</h3>
Job Description
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?&nbsp;MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit <a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on LinkedIn.
Responsibilities:
<ul>
<li>Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client.</li>
<li>Demonstrated ability to lead/ manage multiple individuals and/or groups.</li>
<li>Cross-functionally collaborates and coordinates Transparency deliverables ensuring that timelines and milestones remain on-track and within target.</li>
<li>Strategically assesses resource utilization and forecasting to ensure companywide goals are met</li>
<li>Effectively communicates complex strategic concepts with ability to tailor message to targeted audience.</li>
<li>Demonstrate thought leadership with customers by developing and presenting client industry trends, benchmarking, and other pertinent information. May participate in industry events for this purpose.</li>
<li>Demonstrated ability to lead / manage multiple individuals and/or groups in a global environment.</li>
<li>Directs strategic planning and proactively prepares contingency plans to address unforeseen challenges within group, and cross functionally to ensure uninterrupted delivery and maintain compliance.</li>
<li>Ability to facilitate positive group morale and productivity by appropriately including others in decisions/plans.</li>
<li>Manages staff, makes decisions and advises others on complex problems; understands intra- and inter-departmental implications of decisions and can develop strategic solutions with minimal input.</li>
<li>Direct, manage, and oversee the daily activities and workload of the transparency, PLS, and redaction teams.</li>
<li>Proactively identifies areas for improvement before issues arise and provides strategic proposal/resolution for consideration.</li>
<li>Develops and leads teams with diverse experience and skill sets to achieve intra and inter departmental goals.&nbsp;</li>
</ul>
Requirements:&nbsp;
<ul>
<li>Graduate degree in scientific, medical, clinical discipline or related field, or related experience, Masters preferred.</li>
<li>Minimum of 6 years’ experience in clinical trial transparency, disclosure, or medical writing role</li>
<li>At least 5 years of experience in a CRO environment.</li>
<li>Demonstrated managerial skills and experience preferred.</li>
<li>High level knowledge of drug development process, clinical development, and operations, with a strong understanding of regulatory guidelines.</li>
<li>Excellent scientific writing skills.</li>
<li>Excellent analytical, organizational, and problem-solving skills.</li>
<li>Proficiency with MS Office applications.</li>
<li>Strong communication and presentation skills.</li>
<li>Knowledge of ISO 9001, ISO 27001, 21 CFR Part 11, FDA, and GCP requirements</li>
<li>Understanding of CROs and scientific &amp; clinical data/ terminology, &amp; the drug development process.</li>
</ul>
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0nzcKKEdR0

<h3>Job Description</h3>
Job Description
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?&nbsp;MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit <a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on LinkedIn.
Responsibilities:
<ul>
<li>Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client.</li>
<li>Demonstrated ability to lead/ manage multiple individuals and/or groups.</li>
<li>Cross-functionally collaborates and coordinates Transparency deliverables ensuring that timelines and milestones remain on-track and within target.</li>
<li>Strategically assesses resource utilization and forecasting to ensure companywide goals are met</li>
<li>Effectively communicates complex strategic concepts with ability to tailor message to targeted audience.</li>
<li>Demonstrate thought leadership with customers by developing and presenting client industry trends, benchmarking, and other pertinent information. May participate in industry events for this purpose.</li>
<li>Demonstrated ability to lead / manage multiple individuals and/or groups in a global environment.</li>
<li>Directs strategic planning and proactively prepares contingency plans to address unforeseen challenges within group, and cross functionally to ensure uninterrupted delivery and maintain compliance.</li>
<li>Ability to facilitate positive group morale and productivity by appropriately including others in decisions/plans.</li>
<li>Manages staff, makes decisions and advises others on complex problems; understands intra- and inter-departmental implications of decisions and can develop strategic solutions with minimal input.</li>
<li>Direct, manage, and oversee the daily activities and workload of the transparency, PLS, and redaction teams.</li>
<li>Proactively identifies areas for improvement before issues arise and provides strategic proposal/resolution for consideration.</li>
<li>Develops and leads teams with diverse experience and skill sets to achieve intra and inter departmental goals.&nbsp;</li>
</ul>
Requirements:&nbsp;
<ul>
<li>Graduate degree in scientific, medical, clinical discipline or related field, or related experience, Masters preferred.</li>
<li>Minimum of 6 years’ experience in clinical trial transparency, disclosure, or medical writing role</li>
<li>At least 5 years of experience in a CRO environment.</li>
<li>Demonstrated managerial skills and experience preferred.</li>
<li>High level knowledge of drug development process, clinical development, and operations, with a strong understanding of regulatory guidelines.</li>
<li>Excellent scientific writing skills.</li>
<li>Excellent analytical, organizational, and problem-solving skills.</li>
<li>Proficiency with MS Office applications.</li>
<li>Strong communication and presentation skills.</li>
<li>Knowledge of ISO 9001, ISO 27001, 21 CFR Part 11, FDA, and GCP requirements</li>
<li>Understanding of CROs and scientific &amp; clinical data/ terminology, &amp; the drug development process.</li>
</ul>
Powered by JazzHR
qTczEWqPzx

<h3>Job Description</h3>
Job Description
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?&nbsp;MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit <a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on LinkedIn.
Responsibilities:
<ul>
<li>Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client.</li>
<li>Demonstrated ability to lead/ manage multiple individuals and/or groups.</li>
<li>Cross-functionally collaborates and coordinates Transparency deliverables ensuring that timelines and milestones remain on-track and within target.</li>
<li>Strategically assesses resource utilization and forecasting to ensure companywide goals are met</li>
<li>Effectively communicates complex strategic concepts with ability to tailor message to targeted audience.</li>
<li>Demonstrate thought leadership with customers by developing and presenting client industry trends, benchmarking, and other pertinent information. May participate in industry events for this purpose.</li>
<li>Demonstrated ability to lead / manage multiple individuals and/or groups in a global environment.</li>
<li>Directs strategic planning and proactively prepares contingency plans to address unforeseen challenges within group, and cross functionally to ensure uninterrupted delivery and maintain compliance.</li>
<li>Ability to facilitate positive group morale and productivity by appropriately including others in decisions/plans.</li>
<li>Manages staff, makes decisions and advises others on complex problems; understands intra- and inter-departmental implications of decisions and can develop strategic solutions with minimal input.</li>
<li>Direct, manage, and oversee the daily activities and workload of the transparency, PLS, and redaction teams.</li>
<li>Proactively identifies areas for improvement before issues arise and provides strategic proposal/resolution for consideration.</li>
<li>Develops and leads teams with diverse experience and skill sets to achieve intra and inter departmental goals.&nbsp;</li>
</ul>
Requirements:&nbsp;
<ul>
<li>Graduate degree in scientific, medical, clinical discipline or related field, or related experience, Masters preferred.</li>
<li>Minimum of 6 years’ experience in clinical trial transparency, disclosure, or medical writing role</li>
<li>At least 5 years of experience in a CRO environment.</li>
<li>Demonstrated managerial skills and experience preferred.</li>
<li>High level knowledge of drug development process, clinical development, and operations, with a strong understanding of regulatory guidelines.</li>
<li>Excellent scientific writing skills.</li>
<li>Excellent analytical, organizational, and problem-solving skills.</li>
<li>Proficiency with MS Office applications.</li>
<li>Strong communication and presentation skills.</li>
<li>Knowledge of ISO 9001, ISO 27001, 21 CFR Part 11, FDA, and GCP requirements</li>
<li>Understanding of CROs and scientific &amp; clinical data/ terminology, &amp; the drug development process.</li>
</ul>
Powered by JazzHR
VU02WEQDgI

<h3>Job Description</h3>
Job Description
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?&nbsp;MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit <a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on LinkedIn.
Responsibilities:
<ul>
<li>Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client.</li>
<li>Demonstrated ability to lead/ manage multiple individuals and/or groups.</li>
<li>Cross-functionally collaborates and coordinates Transparency deliverables ensuring that timelines and milestones remain on-track and within target.</li>
<li>Strategically assesses resource utilization and forecasting to ensure companywide goals are met</li>
<li>Effectively communicates complex strategic concepts with ability to tailor message to targeted audience.</li>
<li>Demonstrate thought leadership with customers by developing and presenting client industry trends, benchmarking, and other pertinent information. May participate in industry events for this purpose.</li>
<li>Demonstrated ability to lead / manage multiple individuals and/or groups in a global environment.</li>
<li>Directs strategic planning and proactively prepares contingency plans to address unforeseen challenges within group, and cross functionally to ensure uninterrupted delivery and maintain compliance.</li>
<li>Ability to facilitate positive group morale and productivity by appropriately including others in decisions/plans.</li>
<li>Manages staff, makes decisions and advises others on complex problems; understands intra- and inter-departmental implications of decisions and can develop strategic solutions with minimal input.</li>
<li>Direct, manage, and oversee the daily activities and workload of the transparency, PLS, and redaction teams.</li>
<li>Proactively identifies areas for improvement before issues arise and provides strategic proposal/resolution for consideration.</li>
<li>Develops and leads teams with diverse experience and skill sets to achieve intra and inter departmental goals.&nbsp;</li>
</ul>
Requirements:&nbsp;
<ul>
<li>Graduate degree in scientific, medical, clinical discipline or related field, or related experience, Masters preferred.</li>
<li>Minimum of 6 years’ experience in clinical trial transparency, disclosure, or medical writing role</li>
<li>At least 5 years of experience in a CRO environment.</li>
<li>Demonstrated managerial skills and experience preferred.</li>
<li>High level knowledge of drug development process, clinical development, and operations, with a strong understanding of regulatory guidelines.</li>
<li>Excellent scientific writing skills.</li>
<li>Excellent analytical, organizational, and problem-solving skills.</li>
<li>Proficiency with MS Office applications.</li>
<li>Strong communication and presentation skills.</li>
<li>Knowledge of ISO 9001, ISO 27001, 21 CFR Part 11, FDA, and GCP requirements</li>
<li>Understanding of CROs and scientific &amp; clinical data/ terminology, &amp; the drug development process.</li>
</ul>
Powered by JazzHR
Z3kojtgwB3

<h3>Job Description</h3>
Job Description
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?&nbsp;MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit <a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on LinkedIn.
Responsibilities:
<ul>
<li>Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client.</li>
<li>Demonstrated ability to lead/ manage multiple individuals and/or groups.</li>
<li>Cross-functionally collaborates and coordinates Transparency deliverables ensuring that timelines and milestones remain on-track and within target.</li>
<li>Strategically assesses resource utilization and forecasting to ensure companywide goals are met</li>
<li>Effectively communicates complex strategic concepts with ability to tailor message to targeted audience.</li>
<li>Demonstrate thought leadership with customers by developing and presenting client industry trends, benchmarking, and other pertinent information. May participate in industry events for this purpose.</li>
<li>Demonstrated ability to lead / manage multiple individuals and/or groups in a global environment.</li>
<li>Directs strategic planning and proactively prepares contingency plans to address unforeseen challenges within group, and cross functionally to ensure uninterrupted delivery and maintain compliance.</li>
<li>Ability to facilitate positive group morale and productivity by appropriately including others in decisions/plans.</li>
<li>Manages staff, makes decisions and advises others on complex problems; understands intra- and inter-departmental implications of decisions and can develop strategic solutions with minimal input.</li>
<li>Direct, manage, and oversee the daily activities and workload of the transparency, PLS, and redaction teams.</li>
<li>Proactively identifies areas for improvement before issues arise and provides strategic proposal/resolution for consideration.</li>
<li>Develops and leads teams with diverse experience and skill sets to achieve intra and inter departmental goals.&nbsp;</li>
</ul>
Requirements:&nbsp;
<ul>
<li>Graduate degree in scientific, medical, clinical discipline or related field, or related experience, Masters preferred.</li>
<li>Minimum of 6 years’ experience in clinical trial transparency, disclosure, or medical writing role</li>
<li>At least 5 years of experience in a CRO environment.</li>
<li>Demonstrated managerial skills and experience preferred.</li>
<li>High level knowledge of drug development process, clinical development, and operations, with a strong understanding of regulatory guidelines.</li>
<li>Excellent scientific writing skills.</li>
<li>Excellent analytical, organizational, and problem-solving skills.</li>
<li>Proficiency with MS Office applications.</li>
<li>Strong communication and presentation skills.</li>
<li>Knowledge of ISO 9001, ISO 27001, 21 CFR Part 11, FDA, and GCP requirements</li>
<li>Understanding of CROs and scientific &amp; clinical data/ terminology, &amp; the drug development process.</li>
</ul>
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