Remote - Part-Time - Clinical Tmf Documentation Operations Manager

A highly reputable clinical research organization is currently hiring a qualified Remote Part-Time Clinical TMF Documentation Operations Manager.

eTMF Senior Manager

eTMF Manager will provide subject matter expertise and support required to ensure that the electronic Trial Master File (eTMF) documents are audit and inspection ready.

Ensure the eTMF is managed in accordance with relevant regulations, ICH-GCP guidelines and CRO SOPs.

eTMF Manager provides training and supervision of eTMF staff as needed.

Essential Duties & Responsibilities :

• Maintain expert level knowledge of regulations, guidelines, policies, and practices for TMFManagement (global/international)
• Review the Identification and categorization of clinical documents processed by the eTMF team.
• Ensure scope of work is performed according to eTMF Plans for assigned studies
• Provide or oversee eTMF system training for Sponsor, CRO, or Vendor, as appropriate
• Provide training to eTMF team to ensure current practices, and to provide guidance for individual personal growth.
• Lead and provide direction to staff to ensure that all documentation activities are conducted in compliance with GCP, relevant SOPs, and regulatory requirements and meet appropriate quality standards
• Provide study management operations expertise as needed
• Review source documents and indicate discrepancies of any issues found from the original
• Manage the creation of reports to clients (inventory and discrepancies) and review reports prior to release to Sponsor.
• Reviews eTMF content and identify required relational documents; archive all complete documents
• Oversee the review of scanned documents for completeness and correct orientation of pages for readability
• Creates, builds, populates, manages, QCs, and closes out the Trial Master File for client studies in Veeva Vault
• Ensure compliance with document completeness review and eTMF system outputs to identify trends within and across studies to ensure quality processes associated with the management of the TMF
• Act as a point of contact for project teams, Sponsors, auditors and other external third parties on assigned studies/programs
• Provide analytics to Senior Manager (this can be changed to CTM) on productivity of eTMFTeam in order to assist with budget proposals.
• Assist Project Teams with compliance to eTMF SOPs and eTMF Plans
• Responsible for a compliant and inspection ready (by regulatory authorities) TMF.
• Delegate tasks to eTMF Associate(s (this can be changed to CTAs) and Administrator(s) as appropriate
• Lead and provide direction for internal and external systems used for TMF records

Job Requirements:

• Clinical trials support or pharmaceutical/medical device industry experience is preferred
• Independent experience building Trial Master Files with minimal oversight/direction
• 5+ years TMF management experience in the pharmaceutical/clinical research environment, specifically using electronic records management systems
• Global clinical trials experience is preferred
• Strong organizational, writing and communication skills
• Knowledge of web-based communication tools for conferences and any other IT systems required for the job is preferred
• Experienced in Veeva VAULT required
• 1+ year of personnel management experience
• Bachelor’s degree required
• Demonstrated ability to work independently and remain self-motivated
• Advanced knowledge of ICH/GCP guidelines, FDA regulations, and detailed knowledge of international TMF regulatory requirements and expectations as they pertain to the management and inspection of the TMF
• Previous clinical trials records management experience is preferred
• Previous experience using computerized clinical trials records management technologies is preferred