Clinical Data Manager
MapLight Therapeutics is a clinical-stage biotech company dedicated to discovering and developing therapies for central nervous system disorders. The company utilizes advanced technologies such as optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and create effective treatments for psychiatric symptoms. The Clinical Data Manager will join the Clinical Data Management team, reporting to the Associate Director, and 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 the company's products.
The Clinical Data Manager will manage and lead all aspects of clinical trial data management activities from study start-up to database lock. Responsibilities include developing and implementing data management plans, data validation plans, edit check plans, and data entry guidelines in compliance with regulatory standards and company standard operating procedures. The role involves collaborating with cross-functional teams, including Clinical Operations, Biostatistics, and Regulatory Affairs, to ensure data quality and integrity throughout the trial lifecycle. Additionally, the manager will oversee the setup, configuration, user management, coding, and data extracts of the Medidata Rave electronic data capture system.
Candidates should possess a bachelor's degree in life sciences, computer science, or a related field, with an advanced degree preferred. A minimum of five years of experience in clinical data management within the pharmaceutical or biotechnology industry is required. Proficiency in the Medidata Rave electronic data capture system is essential, along with a strong understanding of Good Clinical Practice guidelines, regulatory requirements (e.g., FDA, EMA), and industry standards (e.g., CDISC). Excellent communication, organizational, and problem-solving skills are necessary, as well as the ability to work effectively in a fast-paced, cross-functional team environment. Attention to detail and a commitment to data quality and integrity are also critical.
This hybrid position requires three days per week onsite at the company's office in Burlington, MA, or Redwood City, CA. Compensation for this role ranges from $145,000 to $160,000 USD annually, with additional benefits including an annual bonus opportunity, medical, dental, vision, life and AD&D insurance, short-term and long-term disability coverage, a 401(k) plan with match, stock options, flexible non-accrual paid time off, and parental leave.