Clinical Data Manager

Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics in vivo physiology and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.

What Youll Do:

We are seeking a highly skilled and motivated Clinical Data Manager to join our Clinical Data Management team. Reporting to the Associate Director the Clinical Data Manager will play a pivotal role in ensuring the integrity accuracy and completeness of clinical trial data contributing to the successful development and regulatory approval of our products.

Responsibilities:

• Manage and lead all aspects of clinical trial data management activities from study start-up to database lock.
• Develop and implement data management plans data validation plans edit check plans and data entry guidelines in compliance with regulatory standards and company SOPs.
• Collaborate with cross-functional teams including Clinical Operations Biostatistics and Regulatory Affairs to ensure data quality and integrity throughout the trial lifecycle.
• Oversee Medidata Rave electronic data capture (EDC) system setup configuration user management coding and data extracts.
• Perform data cleaning discrepancy management SAE and vendor integration reconciliation activities to ensure timely database lock.
• Conduct periodic data reviews and generate weekly data quality metrics to identify trends and outliers.
• Identify Protocol Deviations
• Produce medical monitor coding listings and ad hoc listings for team review (Jreview SAS Business Objects).
• Participate in the development and review of clinical study protocols case report forms (CRFs) and clinical trial documentation.
• Provide support for regulatory submissions audits and inspections related to clinical trial data management.
• Stay current with industry standards best practices and regulatory requirements related to clinical data management.

Qualifications:

• Bachelors degree in life sciences computer science or a related field. Advanced degree preferred.
• Minimum of 5 years of experience in clinical data management within the pharmaceutical or biotechnology industry.
• Proficiency in Medidata Rave electronic data capture (EDC) system..
• Strong understanding of Good Clinical Practice (GCP) guidelines regulatory requirements (e.g. FDA EMA) and industry standards (e.g. CDISC).
• Excellent communication organizational and problem-solving skills.
• Ability to work effectively in a fast-paced cross-functional team environment.
• Attention to detail and commitment to data quality and integrity.

Location: This is a hybrid position with three days per week onsite at our office in Burlington MA or Redwood City CA.

MapLight does not accept unsolicited resumes from recruiters staffing agencies or search firms.

EEOC Statement: MapLight Therapeutics is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion sex national origin sexual orientation gender identity disability status protected veteran status or any other characteristic protected by law.