Clinical Data Manager chez MapLight Therapeutics
MapLight Therapeutics · Burlington, États-Unis d'Amérique · Hybrid
- Professional
- Bureau à Burlington
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 You’ll 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:
- Bachelor’s 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.
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.
