Associate Director, Data Management

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Role Summary

Based in San Diego, CA. This role follows a hybrid model requiring in-office work three days per week on average. The Associate Director will collaborate with the Data Management team to provide leadership and subject-matter expertise. They assist the Head of Data Management in directing the design, documentation, testing, and implementation of clinical data collection studies and database reviews to support company objectives. They ensure data management systems are of appropriate quality and business-ready and oversee data deliverables and CRO-related projects to ensure data integrity.

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 NDA/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 as 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; position may have direct reports. May assist with input into corporate and department budget process and management.
• Other responsibilities as assigned.

Education

• 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.

Qualifications

• Previous experience in data management from protocol concept through database lock and clinical study report finalization.
• Knowledge of medical terminology.
• Knowledge of coding dictionaries (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.

Additional Requirements

• Must be able and willing to travel on occasion.
• Physical requirements: Regular standing, walking, sitting, and use of hands for handling or operating equipment; ability to reach, climb, balance, stoop, kneel, crouch; occasional lifting up to 20 pounds; ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.