Associate Director, eTMF

Regulatory Affairs United States


Description

Position at Regulatory Professionals

Bring your Passion!

Regulatory Professionals, a division of Premier Research, is a consultancy firm specializing in drug, biologics and device regulatory affairs. Our purpose as a company is to support our clients by furthering the development of human therapeutics that will benefit the health and well-being of patients around the world. With a presence in the US, EU, Canada and Japan we are growing and looking for talented people to grow our business, advance the goals of our clients and contribute to our unique culture. Our focus is to provide strategic and tactical support in all aspects of regulatory affairs, including preclinical, CMC and clinical development for drugs, biologics, devices, and combination products.


We are seeking a talented Associate Director, eTMF  to join our growing team at RPI! This position is available as a fully remote role.


The Associate Director, eTMF, is responsible for leading the eTMF Team and overseeing the management of Trial Master File (TMF) activities. The Associate Director, eTMF will manage real-time review of the eTMF to ensure an inspection-ready (by regulatory authorities) TMF. The Associate Director, eTMF will train and supervise relevant eTMF staff.

ROLE RESPONSIBILITIES:

  • Ensure scope of work is performed according to eTMF Plans for assigned studies
  • Ensure that any out-of-scope activities are reported to department management
  • Assist Project Teams with compliance to eTMF SOPs and eTMF Plans
  • Act as a point of contact for Project Teams, Sponsors, Auditors and other external third parties on assigned studies/programs
  • Participate in potential client meetings to provide an overview of RPI eTMF services
  • Review budget proposals for potential clients/projects
  • Provide input and resolutions for discrepancies of any issues identified in the eTMF
  • Provide ongoing quality review of client eTMFs to ensure monthly reporting timeline commitments are met with each individual client
  • Review monthly discrepancy reports prior to distribution to Sponsor(s)
  • Oversee the review of eTMF content and the identification of required relational documents
  • Delegate tasks to eTMF team as appropriate
  • 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
  • Lead and provide direction for internal and external systems used for TMF records management
  • Ensure compliance with document complete review and eTMF system outputs to identify trends within and across studies to ensure quality processes associated with the management of the TMF
  • Responsible for a compliant and inspection ready (by regulatory authorities) TMF
  • Maintain expert level knowledge of regulations, guidelines, policies, and practices for TMF Management (global/international)
  • Provide TMF study management operations expertise as needed for RPI and for clients
  • Develop training materials and oversee training of eTMF team members to ensure adherence to current practices and provide guidance for individual personal growth for the staff

REQUIREMENTS:
  • Bachelor’s degree, or international equivalent from an accredited institution, in information management, library science, clinical, science, or health related field, or an equivalent combination of education and experience
  • 7-9 years TMF management experience in the pharmaceutical/clinical research environment
  • 3-5 years personnel management experience
  • Strong organizational, writing and communication skills
  • Previous clinical trials records management experience is required
  • Previous experience using computerized clinical trials records management technologies is preferred
  • Global clinical trials experience is preferred
  • Clinical trials support or pharmaceutical/medical device industry experience is preferred
  • Knowledge of web-based communication tools for conferences and any other IT systems required for the job is preferred
  • 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
  • Experience with the TMF Reference Model created through the DIA is desirable
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