The candidate must be self-motivated, able to work and lead in a remote team environment and be ... Strong knowledge and experience with TMF/eTMF, EDC systems and CTMS preferred. * Be an initiative ...
The candidate must be self-motivated, able to work and lead in a remote team environment and be ... Strong knowledge and experience with TMF/eTMF, EDC systems and CTMS preferred. * Be an initiative ...
Tmf Manager Remote information
What is the difference between Tmf Manager Remote vs Tmf Coordinator?
| Aspect | Tmf Manager Remote | Tmf Coordinator |
|---|---|---|
| Credentials | Typically requires advanced certifications and experience in TMF management | Usually requires basic TMF knowledge, often with entry-level certifications |
| Work Environment | Remote, strategic oversight, team management | Remote or onsite, focused on document review and data entry |
| Industry Usage | Used in clinical research, pharmaceutical companies, CROs | Common in clinical trial sites, CROs, and pharma companies |
The Tmf Manager Remote oversees TMF processes at a strategic level, managing teams and ensuring compliance, while the Tmf Coordinator handles day-to-day document management tasks. Both roles are essential in clinical research but differ in scope, responsibilities, and required experience.
What are some common challenges faced by a remote TMF Manager, and how can they be addressed?
As a remote TMF (Trial Master File) Manager, one common challenge is ensuring consistent communication and collaboration with global clinical teams, especially when working across different time zones. Maintaining TMF quality and compliance can also be more complex when overseeing dispersed teams and vendors. To address these challenges, it's important to establish clear processes, utilize robust electronic TMF systems, and schedule regular virtual check-ins to monitor progress and address issues proactively. Building strong relationships with team members and providing thorough training on regulatory requirements also helps maintain high standards and project alignment.
What are the key skills and qualifications needed to thrive as a TMF Manager (Remote), and why are they important?
To thrive as a TMF Manager (Remote), you need strong knowledge of clinical trial documentation, regulatory requirements (such as ICH-GCP), and experience with Trial Master File (TMF) management, typically supported by a degree in life sciences or a related field. Familiarity with electronic TMF (eTMF) systems, document management platforms, and relevant certifications like DIA’s TMF Practitioner are common requirements. Exceptional organizational skills, attention to detail, and effective remote communication abilities are crucial soft skills for this role. These competencies ensure regulatory compliance, the integrity of clinical trial documentation, and smooth collaboration across geographically dispersed teams.
What is a TMF Manager (Remote)?
A TMF (Trial Master File) Manager is a professional responsible for overseeing the collection, organization, and maintenance of essential documents related to clinical trials, ensuring compliance with regulatory requirements. Working remotely, a TMF Manager uses electronic systems to coordinate documentation across multiple sites and teams, monitor document quality, and ensure audit readiness. Their role is critical for maintaining the integrity and accessibility of clinical trial records, which are essential for regulatory submissions and inspections.
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Full-time
Posted 11 days ago
Job description
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.
The Manager, Clinical Operations is a seasoned professional with wide-ranging experience and a thorough understanding of clinical study management, biospecimen acquisition, FDA and ICH regulations and Good Clinical Practices (GCP). The candidate must be self-motivated, able to work and lead in a remote team environment and be able to establish strong, positive relationships with both internal departments, external clinical study sites and biospecimen vendors.
The successful candidate contributes to the development of Clinical Affairs processes and procedures at the project and company levels pertaining to Clinical Operations involvement in our clinical studies. The Manager, Clinical Operations will provide leadership and career development, mentoring and training for CRA, biorepository and clinical trial logistics staff as well as is responsible for Clinical Operations staff resourcing.
Tasks/Duties/Responsibilities:
- Manage and facilitate the personal development of CRAs, including fostering career growth, and providing relevant company-specific, ethical, and regulatory trainings. Serves as a mentor and guide to junior employees. In addition, oversee the personal development of clinical trial logistics and biorepository personnel.
- Partner with the Clinical Affairs Director to create and implement the strategic vision for the Clinical Operations team to ensure the high-quality end-to-end management of clinical trials, clinical trial logistics and internal/external biospecimen acquisition.
- Lead Clinical Operations level initiatives for the development, maintenance and implementation of processes, tools, templates and plans.
- Regularly monitor the overall health of the clinical studies from the study initiation to closure including regular evaluation of key metrics (enrollment, site activation), monitoring and escalation of project risks and mitigation plans when appropriate.
- Lead and prepare the content for internal meetings with leadership, internal cross functional teams and external collaborators.
- Functions as a working manager and takes on CRA responsibilities, as needed
- Oversee CRAs during site visits (site initiation visit, interim monitoring visits and close-out visits), as needed.
- Oversee the clinical operations aspects of timely data monitoring and partner with Clinical Affairs team leaders and study sites regarding generation and reconciliation of queries to ensure business timelines are met.
- Direct the creation and collection of required study documents both internally and with the investigational study sites.
- Responsible for all aspects of the biospecimen acquisition program, including forecasting and managing resources, timelines and budgets for external and internal biospecimen acquisition.
- Implement strategies and best practices for the Clinical Operations team to build and maintain relationships with investigational study sites and vendors.
- Responsible for resource allocation for the Clinical Operations team for assigned projects.
- Travel: 30%
- Other duties as assigned.
- B.S. in Biological/Health Sciences or related Scientific fields; master’s degree preferred
- Certificate of completion from a Clinical Research Associate program is preferred
- Minimum of 5 years of experience mentoring, managing, and leading a team
- Minimum of 5 years experience as a CRA and/or Lead CRA
- Minimum of 1-2 years experience with managing and/or working in clinical trial logistics and/or biorepository operations.
- Experience with internal sample collection is preferred.
- Basic knowledge in the areas of microbiology, immunology or molecular biology and biochemistry as related to infectious diseases.
- Thorough knowledge of FDA, ICH and GCP guidelines
- Strong knowledge and experience with TMF/eTMF, EDC systems and CTMS preferred.
- Be an initiative-taker, detail oriented, organized, and able to prioritize and balance workloads to meet strict critical deadlines along with performing under pressure in a fast- paced environment.
- Highly motivated, readily adapts to changing priorities.
- Excellent organizational skills with high attention to detail is required.
- Able to work successfully under tight timelines.
- Ability to manage, prioritize, and routinely report progress on multiple projects to cross functional teams and Clinical Management.
- Ability to read, understand and follow all company SOPs and guidelines and ensures compliance in direct reports.
About Meridian Bioscience
Sourced by ZipRecruiter
Industry
Medical equipment and supplies manufacturing
Company size
501 - 1,000 Employees
Headquarters location
Cincinnati, OH, US
Year founded
1977