Associate Director, Clinical Data Management

Associate Director, Data Management

About

Acadia is dedicated to transforming scientific promise into meaningful innovation for underserved neurological and rare disease communities worldwide. Our commercial portfolio includes treatments for Parkinson's disease psychosis and Rett syndrome, with a robust pipeline addressing other unmet patient needs.

Responsibilities

• Collaborate with the Data Management team, providing leadership and expertise. Assist the head of Data Management in directing the design, documentation, testing, and implementation of clinical data collection studies and database reviews.
• Ensure data management systems are business-ready and of appropriate quality.
• Oversee the quality of data deliverables within Acadia Data Management and projects with Contract Research Organizations (CROs).
• Participate in the collaboration and coordination to design and implement clinical protocols and data collection systems.
• Assist in identifying and resolving data management issues on assigned studies.
• Ensure data management timelines are met within assigned studies, whether in-house or outsourced.
• Provide strategic input into protocol design focused on data management aspects.
• May assist Biostatistics in the development/review of Statistical Analysis Plans.
• Review and resolve data discrepancies for standardized data validation systems and procedures.
• Support data management requirements and deliverables for New Drug Application (NDA)/Marketing Authorisation Application (MAA), including integrated databases.
• Aid in the production of quality data deliverables to support regulatory submissions, publications, and due diligence activities.
• Review clinical, regulatory, and other documents as needed to assure data integrity and quality.
• Oversee projects engaged with CROs and lead internal projects.
• Oversee and manage the final data management electronic Trial Master File (eTMF) for assigned studies.
• Assist with the development of standards and process documentation, including Standard Operating Procedures and Work Instructions.
• Assure compliance with industry quality standards, guidelines, and procedures.
• Assist in the selection and evaluation of new personnel.
• May assist in the career development of Data Management personnel, potentially having direct reports.
• May assist with input into the corporate and department budget process and management.

Requirements

• Bachelor’s degree in Life Sciences, Mathematics, or related field.
• Approximately 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 and coding dictionaries (MedDRA, WHO Drug).
• Excellent verbal and written communication, 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 concepts.
• Skilled at cross-functional/department communications to gain cooperation.
• Proven skill at effectively leading cooperative team efforts and organizing resources.
• Able to make and prioritize process and resource decisions based on overall team needs.
• Must be able to and willing to travel on occasion.
• This position is based in San Diego, CA, with a hybrid model requiring office work three days per week on average.