Precision for Medicine is hiring an experienced TMF Lead/Senior TMF lead to join our team, candidates can work remotely in Serbia, Poland, Hungary, Romania or Slovakia.
The TMF Lead/Senior TMF Lead is responsible for oversight, creation, management, and delivery of the eTMF in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Precision Standard Operating Procedures (SOPs) as appropriate. The Senior TMF Lead may take on responsibility for the complex and/or challenging studies. Additionally, the Senior TMF lead supports the development and implementation of TMF-related processes and systems.
Essential Functions of the job include but are not limited to:
· Creates and executes the study TMF Plan and project TMF Document Index. Ensures entire study team understands expectations, project-specific aspects of the TMF, and manages communication of any changes in the TMF.
· Attends and contributes to project kick-off meetings, project internal or external meetings, and ad hoc meetings as needed to ensure the project team is aware of the status of the eTMF, gaps, and escalations.
· Ensures the eTMF system is updated with the information related to countries, sites, contacts and applicable TMF document requirements.
· Engages and collaborates with the Project Manager and Functional Leads to ensure TMF documentation is submitted in a timely manner and with high quality to maintain the TMF in an inspection-ready state. Anticipates challenges to TMF compliance and identifies early signals of risk. Develops and implements plans to increase compliance and follows-up on non-compliance.
· Monitors and reports on TMF Health to internal team and sponsor. Identifies trends, risks, and overall status of the TMF.
· Serves as point of contact and Subject Matter Expert (SME) for project audits or inspections and supports in the report responses. Escalates to TMF management in cases of significant risk to Precision.
· Initiates and performs Quarterly Completeness/Compliance checks for assigned projects and ensures proper documentation.
· Identifies project team TMF training needs and provides or supports team re-education.
· Manages the close-out activities of assigned studies, including defining the timeline for final document submission, final document processing, close out of all outstanding queries, requesting the eTMF export from the vendor, transfers to the sponsor and collects the Acknowledgement of Receipt.
· Provides training and education to the Clinical Solutions functions to build knowledge and awareness of the good documentation practices and TMF on clinical trials.
· Manages projects within the Sponsor eTMF Systems and actively listens to deliver insightful solutions for challenges.
· Support process development or improvement initiatives within the Records Management department. Train and mentor junior Records Management team members for their TMF responsibilities
· Serves as a System Superuser and carrying out the activities assigned to them within tickets.
Qualifications:
Minimum Required:
- 4-year college degree or equivalent combination of education and experience, ideally in a business, scientific or healthcare discipline.
- At least 3 to 4 years of experience with TMF and/or eTMF with at least 1 year's + experience working as a TMF Lead.
Other Required:
- Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint)
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Ability to speak English proficiently (professional level)
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Ideally have experience using Veeva Vault to process documents
Skills:
- Demonstrates solid interpersonal skills.
- Demonstrates, or can be trained and retain a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance.
- Manage competing priorities effectively.
Competencies:
- Exhibits strong self-motivation.
- Detail-oriented and able to work and plan independently as well as in a team environment.
- Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, and maintain positive interactions with internal and external stakeholders
- Communicates both verbally and in written form in an efficient and professional manner
- Demonstrates values and a work ethic consistent with Precision Values and Company Principles
- Identify when escalations are necessary as well as identify and execute/communicate resolution with leadership support.
#LI-NC1 #LI-Remote
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