Associate Director Data Management

San Diego, CA - USA

Monthly Salary: Not Disclosed

Posted on: 3 days ago

Vacancies: 1 Vacancy

Job Summary

Please note that this position is based in San Diego CA. Acadias 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).

Primary 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 sssist in the career development of Data Management personnel. Position may have direct assist with input into corporate and department budget process and management.
Other responsibilities as assigned.

Education and Experience

Bachelors 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.
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.

Physical Requirements

This role involves regular standing walking sitting and the use of hands for handling or operating equipment. The employee may also need to reach climb balance stoop kneel crouch and maintain visual verbal and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

Required Experience:

Director

Please note that this position is based in San Diego CA. Acadias hybrid model requires this role to work in our office three days per week on average.Position SummaryThe Associate Director will collaborate with the Data Management team by providing leadership and knowledge. Assists the head of Data ...