Acadia Pharmaceuticals Inc. · 1 week ago
Associate Director Data Management
Acadia Pharmaceuticals is committed to turning scientific promise into meaningful innovation for underserved neurological and rare disease communities. The Associate Director will lead the Data Management team, ensuring quality data deliverables and compliance with regulatory standards while collaborating on clinical data collection and oversight of projects with CROs.
BiotechnologyHealth CarePharmaceutical
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
Supports data management 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 assist in the career development of Data Management personnel
May assist with input into corporate and department budget process and management
Other responsibilities as assigned
Qualification
Required
Bachelor's degree in Life Sciences, Mathematics or related field
Targeting 8 years of progressively responsible experience within the pharmaceutical, biotech or CRO industry
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
Proficiency with data management systems and supporting statistical programs (e.g., SAS)
Knowledge of database design and database concepts
Skilled at cross-functional/department communications to gain cooperation of others
Proven skill at effectively leading a cooperative team effort and organizing resources to achieve team goals
Able to make and prioritize process and resource decisions based on overall team needs
Must be able and willing to travel on occasion
Benefits
Medical, dental, and vision insurance
Employer-paid life, disability, business travel and EAP coverage
401(k) Plan with a fully vested company match 1:1 up to 5%
Employee Stock Purchase Plan with a 2-year purchase price lock-in
15+ vacation days
13 -15 paid holidays, including office closure between December 24th and January 1st
10 days of paid sick time
Paid parental leave benefit
Tuition assistance
Company
Acadia Pharmaceuticals Inc.
Acadia Pharmaceuticals develops and commercializes small molecule drugs for the treatment of central nervous system disorders.
Funding
Current Stage
Public CompanyTotal Funding
$811.73MKey Investors
National Institute of Neurological Disorders and StrokeOxford Bioscience PartnersNational Institute of Mental Health
2019-09-17Post Ipo Equity· $287.5M
2018-11-30Post Ipo Equity· $316.25M
2013-01-02Post Ipo Equity· $86.39M
Recent News
2025-11-20
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