Clinical Trial Document Specialist

This is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, this client is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company’s pipeline continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those living with autoimmune and rare diseases.

We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation – TRUE Innovation!

Position Summary:

Reporting to the Clinical Project Manager, the Clinical Trial Document Specialist will support high quality TMFs across Client’s ongoing and completed clinical studies in adherence to regulatory requirements, ICH-GCP guidelines, and standard operating procedures (SOPs). Responsibilities include but are not limited to driving and overseeing successful completion of all TMF deliverables.

Key Responsibilities:

Collaborate with the Project Lead, Clinical Study teams, and CRO to ensure a high level of quality and maintain compliance of TMF through the study life cycle to meet departmental and project goals.
Support study setup, including contributing to the development of TMF Plan, TMF Oversight Plan, Expected Documents Lists, and archival/transfer as required
Monitor operational metrics to support oversight of the TMF
Provide Study teams with routine TMF reports and monitor TMFs for completeness and trends, and drive actions with the cross functional teams as applicable when issues or trends are identified
Collaborate with the Project Lead to identify TMF risks and ensure compliance with internal and regulatory requirements
Oversee the CRO and internal teams as applicable in preparing, handling, distributing, filing and archiving clinical documentation and reports per standard procedures.
Maintain and perform oversight reviews (quality checks) of the Trial Master File for all assigned clinical projects.
Oversee TMF user access management as required
Ensure TMF inspection readiness review of TMF is completed and documented
Support process improvements as the TMF subject matter expert
Attend departmental and trial-specific meetings and discussions, as required
Complete other TMF document-related tasks as required
Support TMF audits and inspections as required
Maintain knowledge of SOPs, DIA reference model, GCP, ICH guidelines, and regulatory standards.

Qualifications:

Bachelor’s degree in biological sciences or related field (or equivalent experience) with related experience in pharmaceutical / biotechnology industry including records management in a GCP-regulated environment.
Excellent written and verbal communication skills.
Proficiency in MS Word, Excel, and Project, with strong analytical and problem-solving abilities.
Detail-oriented, with strong organizational and time management skills.
Experience with Veeva Vault eTMF

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact accommodationrequest@advancedgroup.com.

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