Lead Coordinator, Trial Master File Manager
The Lead Coordinator, Trial Master File Manager is responsible for performing tasks associated with the filing of clinical trial documents, including all documents related to the Clinical Trial Master File (TMF) ensuring that these activities are completed according to internal standards and timelines. You may also mentor junior members of the department and work on special projects related to the area of records management (i.e. inspection).
- Create the study CIL for each study and for the study set-up in the CeDoc system
- Organize a Trial Master File (TMF) kick-off meeting with the appropriate TMF Contributors, and creates the TMF plan for each study (using the “TMF PlanTemplate”) (except for NPP/ISS) in order to describe how to manage the TMF.
- Check eTMF completeness by verifying that all eTMF documents are filed in the eTMF, and by generating TMF & QC Status reports.
- Send to TMF Contributors a “Request for Preparing TMF Pre-archiving” with the timelines to provide their specific TMF documents to the TMF Document Specialist (for paper & electronic studies), and to ensure that all electronic documents are available in the eTMF (for electronic studies).
- Responsible for the eTMF lock which is only performed once the eTMF is complete. Approve eTMF lock request form, and organizes a TMF/eTMF closure meeting.
- Identify and resolve issues / problems which prohibit normal filing activities by using acquired experience and expertise. These issues/problems may include, but are not limited to incomplete filing, illegibility and inappropriate form completion.
- Assist in the preparation of clinical trials documents for internal audit and inspections (sponsor and sites). The Sr. Coordinator is the key contact from Record Management team to answer filing/archiving questions to auditors/inspectors.
- Provide TMF/eTMF status during Study Team meetings and an on-going support to eTMF contributors.
- Work in strong collaboration with the TMF Expert for study CIL set up/updates
- Write procedures (Department SOP, User Manuals) and review specific conventions and rules in relationship with TO staff involved in process. Ensures training of local staff is provided on SOPs and application/systems related to record management.
- Participate in the design, execution and documentation of testing needed to support life cycle management of new and existing applications/systems
- BS degree and minimum of 4 years’ experience in pharmaceutical industry or clinical-related discipline or at least 9 years' experience in pharmaceutical industry or clinical related discipline
- General understanding of the R&D process and previous exposure to GCPs/ICH
- Organizational, interpersonal and communication skills (verbal and written); flexibility, diplomacy, efficient in matrix organization and transverse management
- Self-motivation, attention to detail while overseeing and connecting with cooperating departments; results driven in terms of timelines and quality
- Customer & quality focused
- Understands the clinical development process and GCP's
- Ability to follow guidelines precisely and to follow through on all tasks
- Familiarity with application/systems related to record management
- Learns quickly when facing new problems
- Ability to work independently
- Effective written and oral communication skills
- Clinical Research experience in clinical operations
- Knowledge of ICH Guideline #8 pertaining to the essential documents for the conduct of a clinical trial.