[Hiring] Documents Specialist II @Precision Medicine Group

Role Description

The Documents Specialist II is responsible for preparing TMF plans, document QC and indexing in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Precision Standard Operating Procedures (SOPs) as appropriate.

• Perform document QC and indexing within eTMF for assigned studies.
• Monitor document submission and timely document process, to avoid developing a backlog; escalate as needed to eTMF Management for support.
• Distribute TMF metrics. Follow-up on document in clarification and ensure these are resolved timely.
• Manage the close-out activities of assigned studies, including timeline for final document submission, wrap up of document processing, close out of all documents in close-out, requesting the eTMF export, transfer to the Client and get the Acknowledgement of Receipt.

Qualifications

• 4-year college degree or equivalent combination of education and experience, ideally in a business, scientific or healthcare discipline.
• Minimum 5 years of clinical trial experience.
• Minimum 3 years of experience with TMF and/or eTMF.

Requirements

• 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.