TMF Specialist

The TMF Specialist is responsible for overseeing the overall management and quality of essential clinical trial documents to ensure compliance with applicable regulatory and local requirements. This position will provide management and oversight of Trial Master File (TMF) filing activities to ensure audit and inspection readiness for clinical trials.

Responsibilities:

Works with multi-functional study teams and vendors to ensure the maintenance of TMFs, both electronic and paper, in a state of inspection readiness.

Maintains study-specific TMF Management Plan.

Performing QC on TMF documents to ensure high quality per data quality standards and specified system guidelines

Manages conduct of TMF quality reviews by cross-functional study team; driving to closure quality review findings.

Supports the functional owners in the identification and management of the collection of study specific TMF content, (both sponsor and CRO).

Assessing outstanding issues and following through to resolution

Daily interaction with Clinical team, clinical project managers and members of the cross-functional study team.

Plan, execute, and lead study-specific meetings.

Follow international good clinical practice guidelines/regulations and standard operating procedures for executing clinical studies.

Supports other trial-related operational activities as needed and assigned Requirements

Bachelor's Degree Required

3-5 years of experience working in pharmaceutical/biotechnology or CRO organization in TMF management

Working knowledge of VEEVA Vault

Strong working knowledge of FDA & ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures

Proficient in computer technology used in an office environment (Microsoft Word, Excel, and PowerPoint) and Share point

Exceptional attention to detail.

Ability to work independently and collaboratively with excellent written communication, oral communication, and organizational skills are required

Strong interest in clinical trials and initiative to learn and participate in projects of increasing responsibility

Highly responsive and proactive, a team player

Excellent communication and organizational skills and the ability to work effectively in a high-paced, fast changing environment.

Flexible attitude with respect to work assignments and new learning

Conscientious, influential person with an outstanding work ethic and strong personal discipline

Current authorization to work in the US

Benefits

Dental, Medical, Vision and 401K