Senior eTMF Manager

Company: Regulatory Professionals
Location: Cincinnati
Posted on: February 25, 2021

Job Description:

Regulatory Professionals San Francisco, California Remote, California United States Atlanta, Georgia Austin, Texas Baltimore, Maryland Cincinnati, Alaska Denver, Colorado Las Vegas, Nevada Nashville, Tennessee Morristown, New Jersey New York, New York Portland, Oregon North Brunswick Township, New Jersey Phoenix, Arizona Philadelphia, Pennsylvania Chicago, Illinois Pittsburgh, Pennsylvania DescriptionThe Senior Manager, eTMF, is responsible for electronic Trial Master File (eTMF) review and the completeness of the content for the study. The Senior Manager will oversee that real-time review is performed to ensure an inspection-ready (by regulatory authorities) TMF. The Senior Manager will train and supervises relevant eTMF staff.

Responsibilities:

• Ensure scope of work is performed according to eTMF Plans for assigned studies
• Ensure that any out of scope activities are reported to the Head, eTMF and/or 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 for discrepancies of any issues identified in the eTMF
• 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
• 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 study management operations expertise as needed
• Oversee training of eTMF team members to ensure current practices are adhere to and provide guidance for individual personal growthRequirements:
  
  • 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 preferred
  • 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 You have been redirected to a Regulatory Professionals job page

Keywords: Regulatory Professionals, Cincinnati , Senior eTMF Manager, Executive , Cincinnati, Ohio