Clinical Trial Document Specialist

$94,400 - $118,000/Yr

Zenas BioPharma - Waltham, MA

Full-time - Entry Level

Hybrid - Waltham, MA

Professional, Scientific, and Technical Services

About the position

Zenas BioPharma 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, Zenas 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!

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.

Requirements

• 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.

Benefits

• Annual performance bonus
• Equity
• Full range of benefits
• Other incentive compensation plans