Principal Data Manager

BASIC SUMMARY:

Perform the execution of Clinical Data Management functions with delegated authority. Serve as lead data manager on assigned studies. Serve as a resource for lower level staff. Responsible for administrative supervision of data management staff. Provide management oversight of projects to assure quality and timely database deliveries. Serve as primary liaison with clients and other departments.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

•  Review study-specific documentation as part of the project team to obtain understanding of study-specific data processing conventions.
•  Reconcile project files and other documents generated in data management against a database for accuracy and completeness of data management processes.
•  Investigate and resolve data anomalies.
•  Identify the need for and generate data queries at any point during data processing.
•  Issue and review queries for completeness.
•  Conduct quality control including case report form (CRF) to database review processes.
•  Create test data, perform testing procedure of entry screens and edit checks, and provide test results to the project lead or designee.
•  Manage and work concurrently and accurately on multiple protocols.
•  Execute and manage all coding activities involved with developing and maintaining a clinical trials database for analysis and/or transfer to sponsor.
•  Report routine project status and data trends to departmental management, as required.
•  Create case report forms and/or maintain oversight responsibility for CRF design in accordance with the protocol and established standards.
•  Develop project specific data management plans (DMPs) and other related documentation.
•  Serve as resource for the department and departmental management.
•  Review reports, listings, and other documents generated in data management for distribution to sponsor, investigators, and their study support staff.
•  Design, validate, implement, and maintain projects in any clinical data management system used by the company.
•  Serve as the primary project contact for data management with clinical and sponsor.
•  Assist in monitoring study costs, including estimating time, cost and resources.
•  Assist in staffing assignments for assigned projects, ensuring that the project is sufficiently staffed with qualified personnel and specific project requirements are met.
•  Represent clinical data management in client meetings and presentations.
•  Provide direct daily supervision of specific projects and project personnel, as well as conduct timely and through evaluation of and review work performance of assigned departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures [SOPs, safety procedures and biosafety protocols]. Schedule and prioritize workload of group members.
•  Assist in the interview and selection of qualified exempt and non-exempt personnel. Recom-mend personnel actions, including hiring, and promotions.
•  Assist in providing in-house instruction and mentorship as part of technical career development for lower level Data Management staff, including training, progress assessment, and facilitate technical development for direct report employees. 
• Perform all other related duties as assigned.

QUALIFICATIONS:

• Education: Bachelor’s degree (B.A./B.S.) or equivalent in a scientific, computer, or related discipline. Bachelor’s degree preferred.
• Experience: 3 years’ related experience and 2 years in clinical data management or related field.
•  An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
•  Certification/Licensure: None.
• Other: Experience with relational databases and clinical data management systems. Comprehensive and demonstrated knowledge of the conduct of general data management and data management quality control activities for a clinical study. Demonstrated professional presentation capabilities. Ability to read, write, speak and understand English required.

PHYSICAL DEMANDS:

•  While performing the duties of this job, the employee is regularly required to talk, hear, and type/work at a computer.
•  Specific vision abilities required by this job include close vision and the ability to adjust focus.

WORK ENVIRONMENT:

•  General office working conditions, the noise level in the work environment is usually quiet.

COMMENTS:

•  This position requires occasional domestic/international travel.
•  This position requires a valid driver’s license and the ability to operate a motor vehicle.