Job Title: Direct Hire - Associate TMF Management and Compliance
Location: Woodcliff Lake, NJ
Duration: FULLTIME + BENEFITS
The Associate, TMF Management and Compliance, will be responsible for performing daily support activities ensuring that the Trial Master File (TMF) is compliant and Inspection Ready. The eTMF system has over 2,000 global users, including CROs. Functions include TMF set-up, managing TMF file structures and archiving of Trial Master Files; eTMF query resolution, eTMF user support and training, and assisting with the oversight of the eTMF vendor; performing quality control review of study documents to ensure they adhere to SOPs and meet regulatory requirements and ICH guidelines. This role will be required to work collaboratively across functional areas and contribute to positive team relationships, both locally and globally.
The Associate, TMF Management and compliance, will lead initiatives and will serve as a subject matter expert in TMF Process Management.
- TMF Business Process – assist with maintaining and updating the TMF file structures; conducting continuous improvement and monitoring the business environment to anticipate future areas of risk and need for process changes; collect and evaluate recommendations for improvement from the user community.
- eTMF System & Vendor Support – Assist with oversight of the eTMF vendor to ensure service meets expectations; Interact with eTMF vendor to resolve issues and questions; conduct continuous improvement of the eTMF business process, suggesting updates as appropriate; assist study teams with monitoring the eTMFs for completeness and quality. Perform various TMF activities such as assisting with TMF set up, eTMF user support and training. Assist with developing training materials and conducting TMF training for eTMF users (over 2000 worldwide organization and CRO users).
- Conduct Quality Control Reviews and analysis of TMF documents utilizing a risk-based approach to ensure adherence to SOPS and regulatory requirements. This entails a full quality review of document content and cross-checking of document content compared to various study event dates (e.g., protocol approval; ethics committee approval, etc). Assist with the creation of Study QC Review Plans, which requires understanding the type and phase of study and applying this understanding to determine the appropriate QC Review strategy for the study. Conduct study risk assessments by evaluating various study parameters to determine level of risk associated with study and corresponding % of sites to be QC reviewed. Assist with analyzing trends across studies and countries utilizing various metrics. This requires the ability to understand regulatory requirements and be able to interpret and make discretionary decisions based on the interpretation.
- Perform eTMF query resolution, for eTMF document submissions identified by the eTMF Vendor processing team as not following the client TMF file structure and eTMF Business Rules. This involves interpreting the TMF Filing Structure guidance and eTMF Business Rules and making independent, discretionary decisions to appropriately resolve the queries. Queries that are not resolved appropriately can result in organization being out of compliance with regulatory requirements, and/or significant cost to organization (redundancy, rework, etc)
- Assist in the archiving of TMF documents according to regional requirements; this may include shipping, retrieval, and tracking of documents approved for archiving to off-site storage as directed in all applicable Sops; maintain electronic logs which contain the location of study documents.
- Make recommendations for improvements to departmental SOPs and work guidelines.
- Bachelor’s degree, preferably in a scientific discipline or equivalent work experience
- Min of 3 years in pharma
- Must have good understanding of clinical development, including regulatory documents and regulatory requirements (including ICH and GCP guidelines), and be able to interpret and make decisions based on the interpretation
- Must have strong document management skills, including experience with review of Regulatory Documents, be detail oriented, organized, quality driven and able to work in a team environment under tight deadlines
- Knowledge/understanding of TMF requirements and technologies to suport document collection and archiving; eTMF experience preferred
- Must have critical reasoning skills, including the identification and resolution of complex problems
- Must be proficient in MS Office
- Must have strong verbal, written and interpersonal communication skills
- Shows high level of initiative and has ability to work independently