TMF Specialist

Job Description

Job Description

Who we are…

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer.

The Trial Master File Specialist will work proactively and collaboratively with our Clinical Operations team, Clinical Quality, and other collaborating teams to ensure the successful delivery of high-quality Trial Master File (TMF). This position is responsible for collecting, reviewing, maintaining, and archiving essential regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 812, ISO 14155, EMA Clinical Trials Directives), and Standard Operating Procedures (SOPs), as appropriate. This position will work closely with the global clinical operation teams to ensure that the TMF is kept both current and inspection ready. This role may also serve as the System Owner for any Clinical Operations systems that are used at Nuvation Bio, ensuring that within the systems, all studies are inspection-ready.

• Be the primary contact for internal eTMF, CTMS, and any other clinical systems, including implementation, maintenance, and end user training.
• Support activities to ensure the clinical systems used by Clinical Operations are validated and compliant with regulatory guidelines (e.g., ICH GCP, FDA, EMA)
• Manage the eTMF document lifecycle, including when applicable, uploading, versioning, reviewing, approving, and archiving documents in compliance with applicable regulations and study timelines
• Perform quality control (QC) checks and ensure accuracy, completeness, and compliance of filed documents
• As necessary, assist in the development and maintenance of CTMS, TMF-related standard operating procedures (SOPs), processes, and templates aligned with ICH E6 (R3) and GCP standards
• Conduct routine TMF quality reviews in accordance with the TMF Plan
• Support internal and external inspections and audits related to the eTMF
• Offer technical support and troubleshooting for eTMF and CTMS system users
• Collaborate with cross-functional teams (e.g., Clinical Operations, CROs, Partners etc.) to ensure alignment on eTMF requirements and timelines
• Support Study Operational Leads with the set-up of any TMF with vendors to ensure adequate implementation, including review process, ensuring TMF completeness and managing the transfer of the TMF.
• Performs other related duties and assignments as required

Minimum Educational Requirement:

• Bachelor’s degree in life sciences, healthcare, or a related field preferred; equivalent work experience will be considered.

Experience:

• Minimum of 2+ years of experience working with electronic TMFs, additional experience in clinical research preferred
• Familiarity with clinical trial operations and ICH/GCP guidelines.

Core Competencies:

• Excellent organizational, communication, and problem-solving skills
• Ability to work independently and collaboratively in a fast-paced environment
• Proficiency in using eTMF systems (e.g., Veeva Vault, Phlexglobal, Wingspan)
• Working knowledge of the DIA reference model
• Hands-on experience with eTMF systems is required.

Communication & Interpersonal Skills:

• Excellent written and verbal communication skills in English. Written and verbal Chinese language is a plus.
• Ability to manage multiple tasks and work both independently and within a team environment

• Problem-Solver - As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
• Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
• Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
• Emotional intelligence , curiosity, and a knack to figure out a way to build something better
• Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders.
• Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity.
• Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.

• Competitive Base Salary, Bonus, and Equity Plans
• Unlimited Vacation and 10 Sick Days Annually
• Excellent Medical, Dental, and Vision Coverage
• 401K with Company Matching
• and much more!

The base pay offered will take into account internal equity and also may vary depending on the candidate’s job-related knowledge, skills, experience, and location among other factors. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered.

Disclaimer

Nuvation Bio, Inc. is an equal opportunity employer, and, in accordance with applicable federal, state, and/or local law, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.

This job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Note to all external Recruiters & Staffing Agencies
All of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.