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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.