This position will assume technical leadership for all activities related to clinical data management (CDM) across Neumora’s clinical programs, be accountable for resource planning, coaching/mentoring, and working closely with Clinical Operations to ensure scientifically sound data collection to support clinical trial objectives and timely delivery of high-quality clinical trial databases. In addition, this position will be hands-on and working on specific tasks within the space of CDM.

Reporting to the VP, Biometrics, this position will be part of the Biometrics leadership to create processes that enable collaboration among Biostatistics, Statistical Programming and CDM and use modern data sciences technology to ensure trial data quality. This role also assumes the responsibility of managing vendors who provide services to data management activities for Neumora’s clinical trials ensuring high quality deliverables.

Responsibilities:

• Lead data management efforts to support study start-up activities from eCRF design, study database design and go-live, to the creation of industry standard documents that specify activities to ensure the management of data quality throughout the clinical study.
• Lead Neumora’s CDM group to deliver documents that directly impact trial data quality, including but not limited to Data Management Plan, CRF Completion Guideline, Data Transfer Agreements and Specifications.
• Create a process that enables systematic data cleaning and the engagement of Clinical Development, Clinical Operations and other relevant functions, and lead the effort to execute the plan to ensure high quality trial data to support interim or final data analysis.
• Provide technical leadership for CDM tasks from data collection, events and medications coding, ongoing trial data review, issuing and closing queries to reconcile data from different sources so that tasks are completed with systematic approaches and best possible scientific approaches.
• Oversee database lock activities and deliver high quality databases for analysis and reporting; and work with Biometrics leadership and Neumora IT to ensure secure repository of the final clinical trial databases.
• Create necessary SOPs to ensure GCP compliance in Neumora CDM activities.
• Lead the effort for eCRFs standardization with the purpose of reducing time and resources when building a trial database and enhancing the efficiency of creating analyzable datasets; implement the standards for new clinical trials through vendor collaboration.

Qualifications:

• S. / B.A. in scientific discipline (M.S. or equivalent preferred), with at least 15 years of experience working as the CDM leader in biotech/pharmaceutical companies.
• Rich experience with building and leading a CDM team in biotech or pharmaceutical environment to provide best possible CDM support to clinical trials from start to completion.
• Proficiency in navigating external vendors to achieve a clean and reconciliated trial database.
• Successful track record of creating and executing a Data Review Process to enable achieving database lock with quality and speed.
• Proficient with an electronic data capture (EDC) system, the development of CRFs and setting up all the related documents to ensure the quality of data collection.
• Deep knowledge about coding dictionaries, including MedDRA and WHODrug.
• Excellent interpersonal skills and communication skills.
• Is open-minded and able to adapt modern technology to make CDM activities more automated.

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: $231,616- $257,345