Senior Document Specialist

Position Summary:
The Senior Documents Specialist is responsible for providing support to the TMF content owners (both internal and external) on one or more clinical programs. This position will work closely with the Project team to ensure that the TMF is kept both current and inspection ready.

Essential functions of the job include but are not limited to:
• Prepare TMF plans for assigned studies

Meet with the Study team to establish the list of required study documents, country/site list and current site contacts
• Configure the study within the eTMF to the specifications provided by the study team
• Provide TMF support to clinical trial activities conducted by Precision
• Monitor TMF status and run metric reports monthly to distribute to the study team
• Train and mentor junior clinical document specialists in the performance of TMF responsibilities

Qualifications:

Minimum Required:

• 4-year college degree or equivalent combination of education and experience, ideally in a business, scientific or healthcare discipline
• Minimum 7 years of experience with TMF and/or eTMF

Other Required:
• Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel and PowerPoint)
• Ability to speak English proficiently (professional level)

Competencies:
• Demonstrates, or is able to be trained and retain a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance
• Demonstrates solid interpersonal skills
• Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment
• Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, and maintain positive interactions with internal and external stakeholders
• Communicates both verbally and in written form in an efficient and professional manner
• Demonstrates values and a work ethic consistent with Precision Values and Company Principles