Senior Data Manager

Position Summary:

 

The Senior Data Manager, under limited direct supervision, has responsibility for the planning, data specification, data oversight and delivery activities and milestones associated with managing clinical research studies from start-up through final locked database.  The Data Manager participates in project initiation, conduct, and closing activities that include, but are not limited to, project-specific document preparation, internal and external team meetings, clinical trial site and customer communication, and on-going monitoring of the quality of data.  The Data Manager, as part of the study project team, is accountable to the Project Manager, and collaborates with Medical Operations and Technical Operations to ensure successful data delivery to the customer.

 

General Responsibilities:

 

Data SpecificationProvides detailed operational input into project planning, focused on data specifications and data management concernsWorks directly with customers on definition and/or review of data specifications through test data transfer and approvalAssists in defining database set-up and testing to ensure desired results can be achievedCoordinates all processes required to produce accurate, confidential and retrievable clinical data

Data management processes and technologyCollaborates and coordinates with others in the design, documentation, testing and implementation of clinical data management systems and procedures, and clinical database reviewSupports implementation of technology-enabled processes, working in partnership with other internal groups

Data standardsDevelops and documents data standards, specifications and proceduresDesigns and tests data validation logic checks

Dataset preparationCoordinates dataset preparation process, including generating datasets using previously validated programs, quality control review of output, and resolution of queries from dataset recipients.

Requirements/Qualifications:

 

Education:

 BA/BS degree in a technical, business or scientific discipline

 

Experience: 

 

· Three (3) to five (5) years experience in clinical trial data management for multiple clinical trials, including large multi-center trials, preferably in a CRO, pharmaceutical or biotech environment

· Data analysis experience, particularly definition and specification of data structures, database design concepts and data output options

· Demonstrable expertise with applicable regulatory guidance and rules, e.g., GCP, ICH E14, 21 CFR Part 11, FDA guidance

 

Special Skills/Abilities:

 Thorough understanding of clinical data management processes and issues, clinical study objectives and methodologies

· Knowledgeable about data and file structures, database design and output options

· Proficient in use of computer systems, including Microsoft Office applications such as Excel, Word, PowerPoint, and relevant systems used in processing clinical data

· Good project management and organization skills

· Demonstrated ability to communicate verbally and in writing, and interact effectively with internal and external customers

· Familiarity with clinical data management systems, tools such as SAS.