MapLight Therapeutics

Clinical Data Manager

Burlington, MA · Director

Sponsorship not specified$145k-$160kDetected 71 days ago

GCPRecruitingFDA RegulatorySASAnimal StudiesCommunicationProblem SolvingGxPBiostatisticsRegulatory Affairs

About the role

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.
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

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.
Perform data cleaning, discrepancy management, SAE and vendor integration reconciliation activities to ensure timely database lock.
Provide support for regulatory submissions, audits, and inspections related to clinical trial data management.

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).
Ability to work effectively in a fast-paced, cross-functional team environment.
Bachelor's degree in life sciences, computer science, or a related field. Advanced degree preferred.
Excellent communication, organizational, and problem-solving skills.
Attention to detail and commitment to data quality and integrity.
MapLight does not accept unsolicited resumes from recruiters, staffing agencies, or search firms.
Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. Additional compensation/benefits include annual bonus opportunity, medical, dental, vision, life and AD&D, short term and long term disability, 401(K) plan with match, stock options, flexible non-accrual paid time off, and parental leave.

MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders.

$145,000 - $160,000 USD
Additional compensation/benefits include annual bonus opportunity, medical, dental, vision, life and AD&D, short term and long term disability, 401(K) plan with match, stock options, flexible non-accrual paid time off, and parental leave.

Produce medical monitor, coding listings and ad hoc listings for team review (Jreview, SAS, Business Objects).

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.
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.

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.

This listing is sourced directly from MapLight Therapeutics's careers page and normalized into a canonical job model.