Associate Director, Clinical Data Management
Acadia Pharmaceuticals
3 days ago
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
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. Ensures data management systems meet business readiness and quality objectives. Oversees quality data deliverables within Acadia Data Management and projects with CROs.
Primary Responsibilities:
- Collaborate to design and implement clinical protocols and data collection systems.
- Identify and resolve data management issues on assigned studies.
- Ensure data management timelines are met (in-house or outsourced).
- Provide strategic input into protocol design for data management portions.
- Assist Biostatistics with development/review of Statistical Analysis Plans.
- Review and resolve data discrepancies for standardized data validation systems/procedures.
- Support NDA/MAA data management requirements and deliverables, including integrated databases.
- Produce quality data deliverables supporting regulatory submissions, publications, and due diligence.
- Review clinical/regulatory documents as needed to assure data integrity and quality.
- Oversee CRO-engaged and internal data management projects.
- Oversee/manage final data management eTMF for assigned studies.
- Develop standards and process documentation (SOPs/Work Instructions).
- Ensure compliance with industry quality standards, guidelines, and procedures.
- Assist with selection/evaluation and career development of data management personnel (may have direct reports).
- Other responsibilities as assigned.
Education & Experience / Qualifications:
- Bachelor’s degree in Life Sciences, Mathematics, or related field; ~8 years progressively responsible experience in pharma/biotech/CRO.
- Data management experience from protocol concept through database lock and clinical study report finalization.
- Knowledge of medical terminology and coding dictionaries (MedDRA, WHO Drug).
- Communication, interpersonal, and organizational skills.
- Proficiency in MS Office; data management systems; SAS (or equivalent statistical programs).
- Knowledge of database design/concepts; cross-functional communication; leading cooperative teams.
- Able to travel occasionally.
Benefits/Compensation (as stated):
- Eligible for discretionary bonus and equity awards.
- Salary range: $144,000—$179,600 USD.
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. Ensures data management systems meet business readiness and quality objectives. Oversees quality data deliverables within Acadia Data Management and projects with CROs.
Primary Responsibilities:
- Collaborate to design and implement clinical protocols and data collection systems.
- Identify and resolve data management issues on assigned studies.
- Ensure data management timelines are met (in-house or outsourced).
- Provide strategic input into protocol design for data management portions.
- Assist Biostatistics with development/review of Statistical Analysis Plans.
- Review and resolve data discrepancies for standardized data validation systems/procedures.
- Support NDA/MAA data management requirements and deliverables, including integrated databases.
- Produce quality data deliverables supporting regulatory submissions, publications, and due diligence.
- Review clinical/regulatory documents as needed to assure data integrity and quality.
- Oversee CRO-engaged and internal data management projects.
- Oversee/manage final data management eTMF for assigned studies.
- Develop standards and process documentation (SOPs/Work Instructions).
- Ensure compliance with industry quality standards, guidelines, and procedures.
- Assist with selection/evaluation and career development of data management personnel (may have direct reports).
- Other responsibilities as assigned.
Education & Experience / Qualifications:
- Bachelor’s degree in Life Sciences, Mathematics, or related field; ~8 years progressively responsible experience in pharma/biotech/CRO.
- Data management experience from protocol concept through database lock and clinical study report finalization.
- Knowledge of medical terminology and coding dictionaries (MedDRA, WHO Drug).
- Communication, interpersonal, and organizational skills.
- Proficiency in MS Office; data management systems; SAS (or equivalent statistical programs).
- Knowledge of database design/concepts; cross-functional communication; leading cooperative teams.
- Able to travel occasionally.
Benefits/Compensation (as stated):
- Eligible for discretionary bonus and equity awards.
- Salary range: $144,000—$179,600 USD.