As part of the Data Management (DM) team, responsible for study-specific data management activities, including study set up, maintenance, data review, and database closure.
The Sr. CDM will act as a project lead.
Reviews protocols and provides input relevant to data management issues.
Oversees/leads all data management activities for clinical studies either directly or overseeing a Clinical Research Organization (CRO).
Manages DM study activities with vendors, including external labs (transfer specifications and timelines) and Electronic Data Capture (EDC) vendor (DB build, User Acceptance Testing (UAT), maintenance, and lock)
Collaborates with other departments on clinical study start up (e.g. case report form (CRF) design), clean up, and closeout.
Responsible for study-specific DM documentation including the Data Management Plan, database creation/validation including edit checks, and query generation/resolution.
Responsible for clinical study data maintenance, data listings, entering queries, reviewing query resolutions, etc.
Provides input on general data management documents such as SOPs and CRF templates.
BA/BS in Life Sciences or equivalent combination of relevant education and applicable job experience.
Minimum 8 years of experience in clinical data management.
Hands on training and experience in clinical trial methodology and Good Clinical Practice.
Excellent understanding of all aspects involved in the data management responsibilities throughout a clinical trial.
Experience with Medidata’s Rave system including strong J-Review skills.
Proficient organizational and documentation skills.
Excellent written and verbal communication skills.
Strong understanding of regulatory guidance and regulations (eg. International Conference on Harmonisation (ICH), 21CFR Part 11, etc.).
Strong understanding of CDISC and CDASH standards.
Must be a team player who works effectively with other disciplines.
Employer will assist with relocation costs.
Additional Salary Information: plus an annual target bonus and stock options
Internal Number: 2428
About Acadia Pharmaceuticals
At ACADIA, we are passionate about improving the lives of patients with central nervous system (CNS) disorders. We are building the foundation to become a leading biopharmaceutical company dedicated to developing and commercializing innovative therapies in the CNS area.