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Senior Manager, Trial Master File (TMF) Lead

Neumora Therapeutics

Neumora Therapeutics

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Posted on Wednesday, February 7, 2024

At Neumora, we are pushing the boundaries of science and technology to revolutionize the way patients with brain disease are treated. We are seeking extraordinary individuals to join our team as we grow and advance our pipeline.

Responsibilities & Duties:

  • The Trial Master File (TMF) Lead is responsible for the planning and day-to-day management of electronic TMF (eTMF), ensuring consistency with ICH-GCP guidelines, regulatory requirements, and applicable SOPs.
  • The role includes oversight of the eTMF held by Neumora or held by contract research organizations (CROs) and review of the eTMF for completeness, accuracy, and timeliness with the goal of being inspection ready at all times.
  • Lead the development and implementation of the study-specific eTMF plans.
  • Serve as the business owner / administrator of the eTMF system software (e.g., Veeva Vault).
  • Serve as the single point of contact related to TMF processes and activities, addressing eTMF questions pertaining to document filing and system access.
  • Perform quality control of documents submitted to the eTMF using the established acceptable criteria.
  • Ensure clinical study documentation is consistent with eTMF specifications, ICH-GCP guidelines, regulatory requirements, and applicable SOPs.
  • Ensure resolution or corrective action when clinical study documentation does not meet the expectations.
  • Monitor and identify study-specific eTMF issues or trends and communicate to Clinical Operations and/or other functional teams, as needed.
  • Identify opportunities for continuous improvement and provide best practice recommendations, as needed.
  • Provide input to the writing of SOPs related to the TMF.
  • 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.

Qualifications & Skills:

  • BA/BS degree or higher, preferably in life sciences
  • Relevant clinical and TMF experience at a biotechnology, pharmaceutical company or CRO: 5 – 7 years of experience
  • Prior experience working in eTMF system software (e.g., Veeva Vault) and CDISC TMF reference model
  • Prior experience developing the eTMF plan when clinical studies are fully outsourced
  • Thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements
  • Excellent oral and written communication skills required with the ability to effectively understand and present information and deal confidently with internal and external stakeholders
  • Initiative, excellent attention to detail, and ability to achieve high performance are required
  • Proactive approach to problem-solving
  • Computer literate with well-developed skills in the use of Microsoft suite of programs (Word, Excel, PowerPoint, Visio, and Outlook)
  • Limited travel may be required

Company benefits include:

  • Medical, dental, vision, and life insurance
  • 401k plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution)
  • New hire stock options
  • Annual paid time off: 15 accrued vacation days, 10 sick days, 12 holidays plus a winter shut-down
  • Leave of Absence: Paid family leave, paid short- and long-term disability
  • Discretionary year-end bonus
  • The salary range posted describes the minimum to maximum base salary range for this position in the location listed. Actual salary may vary based upon geographic location, work experience, education, licensure requirements and/or skill level and will be finalized at the time of offer. Base Salary Range: $148,307 - 159,030.

Neumora Therapeutics is a clinical-stage biopharmaceutical company founded to confront the global brain disease crisis by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of multiple clinical and preclinical neuroscience programs that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases. Our work is supported by an integrated suite of translational, clinical, and computational tools to generate insights that can enable precision medicine approaches. Neumora’s mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients suffering from brain diseases.

Neumora is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

This job is no longer accepting applications

See open jobs at Neumora Therapeutics.