Associate Director, Clinical Data Management

About Acadia Pharmaceuticals Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs.

At Acadia, we’re here to be their difference. Please note that this position is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary The Associate Director will collaborate with the Data Management team by providing leadership and knowledge. Assists the head of Data Management in directing the design, documentation, testing and implementation of clinical data collection studies, and clinical database reviews in support of company objectives. Ensures that the data management systems are business ready and of appropriate quality to fulfill those objectives.

Focuses on the oversight of quality data deliverables within Acadia Data Management and projects with Contract Research Organizations (CROs).

Responsibilities

Participates in the collaboration and coordination with others to design and implement clinical protocols and data collection systems. Assists in identifying and resolving data management issues on assigned studies. Responsible for ensuring data management timelines are met within assigned studies, in-house or outsourced.

Provides strategic input into protocol design focused on data management portions. May assist Biostatistics in development/review of Statistical Analysis Plans. Reviews and resolves data discrepancies for standardized data validation systems and procedures, when applicable.

as assigned. Education and Experience Bachelor’s degree in Life Sciences, Mathematics or related field. Targeting 8 years of progressively responsible experience within the pharmaceutical, biotech or CRO industry.

An equivalent combination of relevant education and experience may be considered. Previous experience in data management from protocol concept through database lock and clinical study report finalization. Knowledge of medical terminology.

Knowledge of coding dictionaries (Medical Dictionary for Regulatory Activities -MedDRA, WHO Drug) Excellent verbal and written communication skills as well as interpersonal and organizational skills Proficiency in MS Office applications. , SAS), Knowledge of database design and database concepts.

Requirements

and deliverables for New Drug Application (NDA)/Marketing Authorisation Application (MAA), including integrated databases. Aids in production of quality data deliverables to support regulatory submissions, publications and due diligence activities. Reviews clinical, regulatory and other documents, as needed, to assure data integrity and quality.

Oversees projects that have been engaged with CROs, as well leads and manages internal projects. Oversees and manages final data management electronic Trial Master File (eTMF) for assigned studies. Assists with the development of standards and process documentation, including Standard Operating Procedures and Work Instructions.

Assures compliance with industry quality standards, guidelines and procedures. Assists in the selection and evaluation of new personnel to ensure the efficient operation of the function. May sssist in the career development of Data Management personnel.

May assist with input into corporate and department budget process and management.