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Contractor - eTMF manager

Mountain View, CA 94043

Posted: 12/19/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 616450 Is job remote?: Yes Country: United States

Job Description

As part of the Clinical Operations team, the temporary eTMF Manager oversees and manages the development and implementation of eTMF procedures, processes, systems, and training over the study lifecycle in compliance with SOPs and regulatory requirements. The eTMF Manager must have an in-depth knowledge of Inspection Readiness/Preparedness practices and procedures. In addition, the eTMF Manager must actively collaborate with clinical stakeholders and external stakeholders (CROs).
 
Qualifications:
 
· Bachelor’s degree or equivalent is required.
· Ideal candidate will have at least 5 years of relevant experience in either sponsor or CRO (at least 3 years eTMF management experience).
· Sound knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations.
· Excellent planning, organizational and time management skills, including the ability to support and prioritize multiple projects.
· Experience managing and maintaining eTMF system
· Must have extensive experience with Veeva Vault system (eTMF and CTMS)
· Extensive knowledge of clinical documents that are maintained in the eTMF
· Prior inspection readiness experience is highly desired.
 
Responsibilities:
· Oversee and manage the set-up, maintenance, and archival of the Trial Master File (TMF), including the tracking, reporting and analysis of metrics related to clinical trial documentation and administration of the electronic TMF (eTMF).
· Maintain inspection/audit readiness while driving completion of the eTMF.
· Serve as a business administrator of the eTMF.
· Support TMF operations during eTMF implementation, audits, and/or regulatory inspections
· Primary point of accountability for the TMF processes and systems; ownership of the eTMF system, including managing and maintaining the system.
· Provide adequate training to study teams, including external partners and CRO staff, to ensure that TMF documents are processed in a timely manner and per SOP.
· Represent TMF operations at study team meetings, participate in collaborative efforts, and play an important cross-functional role in TMF document retrieval and management.
· Coordinate the long-term storage archival of original documents and maintain document integrity, per mandatory retention policies.
· Ability to maintain a high level of accuracy and attention to detail in fast-paced environment with shifting priorities.
· Demonstrate understanding of the TMF Reference Model filing structure, and clinical electronic document management systems (EDMS)
· Self-motivated and able to thrive in a fast-paced, start-up environment.
 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Mountain View, CA

Explore exciting job opportunities in the vibrant area around Mountain View, California! Known for being the heart of Silicon Valley, this region offers unparalleled growth prospects and an innovative tech-driven environment that is perfect for career advancement. With landmarks like the iconic Googleplex and the Computer History Museum, and nearby attractions such as Shoreline Amphitheatre and NASA Ames Research Center, there's no shortage of inspiration in this dynamic area. Enjoy the diverse cuisine, thriving art scene showcased at the Mountain View Center for the Performing Arts, and the beauty of nearby parks like Shoreline Park and Stevens Creek Trail. Join us in discovering the endless possibilities for professional and personal growth in Mountain View!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.