Trial Master File Specialist

ORGANIZATION

RemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein engineering/design technologies, and extensive knowledge in clinical development, our vision is to uncover the novel therapeutic targets and develop the best-in-class and first-in-class biotherapeutics for the patients with significant unmet medical needs. RemeGen Biosciences is a wholly owned subsidiary of RemeGen Co. Ltd, a global pharmaceutical company specialized in autoimmune, oncology and ophthalmic diseases.

POSITION SUMMARY

As the Trial Master File (TMF) Specialist, you will be responsible for the day-to-day management of TMF, including oversight of the review and approval of TMF documents and generation of reports to measure completeness, accuracy, and timeliness of the TMF. This role works very closely with Clinical Operations and other departments that have a contribution to the TMF for studies. This role has a strong focus on ensuring that document management operations are performed with adherence to ICH-GCP guidelines, other regulatory requirements, and standard operating procedures (SOPs). The role will also ensure the TMFs for clinical studies are inspection ready at all times. This is a remote role open to candidates in Massachusetts, Pennsylvania, South Carolina, and Texas.

KEY RESPONSIBILITIES
 

• Lead the development of the study specific TMF plans for assigned clinical studies.
• Perform quality control of documents submitted to the TMF using the established acceptable criteria.
• Ensure clinical trial documentation is consistent with TMF specifications, ICH-GCP guidelines, regulatory requirements, and applicable SOPs.
• Address TMF questions pertaining to how documents are filed, and user questions related to the TMF system.
• Attend study steam meetings and be the point of contact for TMF related matters.
• Ensure documents which fail TMF quality control and/or TMF quality review are effectively remediated and provide best practice recommendations, as needed.
• Ensure Essential Document Lists (EDLs) are maintained on an ongoing basis.
• Monitor and identify study-specific TMF trends and communicate to Clinical Operations and/or other functional teams as needed.
• Assist with inspection/audit related activities (e.g., preparation, correction action plans).
• Maintain up to date knowledge of the TMF reference model, industry best practices and regulatory requirements.
• Assist in developing training material in relation to the TMF and present to staff and stakeholders.
• Actively be involved in the coordination of the transfer/migration of TMFs from CROs.

REQUIREMENTS
 Education:

• Bachelor’s degree in science, healthcare or related field required.

Experience:

• 3+ years of clinical research and TMF experience within biotech, pharmaceutical, or CRO settings required.
• 3+ years in clinical research
• Proficiency with eTMF platforms (Veeva, Trail Interactive, WingSpan, etc.).
• Deep understanding of the clinical trial process and TMF management.
• Familiarity with TMF Reference Model Structure.
• Strong knowledge of ICH-GCP guidelines and regulatory requirements related to clinical document management.

Skills:

• Strong adherence to ALCOA+ standard, GCP, Good Document Practices, and ICH E6 guidelines.
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
• Excellent written and verbal communication skills.
• Ability to work cross-functionally in a fast-paced, collaborative environment.
• Strong attention to detail and problem-solving skills.

OTHER
 Supervisory Responsibilities:None.
 Equipment To Be Used:Laptop computer, other office equipment, and/or lab equipment.
 Typical Physical Demands:Manual dexterity sufficient to operate standard office equipment.
 Working Conditions:Works remotely. Occasionally called upon to work hours in excess of your normal daily schedule. Travel as needed.
BENEFITS
 Benefits:

• 401(k) and matching program
• Medical, Vision, and Dental Insurance
• Flexible Spending Account
• Short- and long-term disability
• Life insurance
• Employee Assistance Program
• Employee discounts
• Paid time off/vacation/sick time
• Professional development assistance
• Referral program

RemeGen Biosciences is an Equal Opportunity Employer. RemeGen Biosciences’ success depends heavily on the effective utilization of qualified people, regardless of their race, ancestry, religion, color, sex, age, national origin, sexual orientation, gender identity and/or expression, disability, veteran’s status, or any other characteristic protected by the law. As a company, we adhere to and promote equal employment opportunity (EEO) for all.

Must be able to work legally in the United States without sponsorship from employer.
 

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