Part-Time Principal DM II

 ***** This is a part-time, hybrid role based in either our Durham, NC or Wilmington, NC office ****** 

BASIC SUMMARY:

Manage the technical and administrative development and execution of the data management functions of clinical trials for multiple and complex projects. Execute data management functions in accordance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs).

ESSENTIAL DUTIES AND RESPONSIBILITIES:

•  Manage and work concurrently on multiple protocols.
•  Manage coding activities involved with developing and maintaining a clinical trials database for analysis and/or transfer to sponsor.
•  Create case report forms (CRFs) 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.
•  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.
•  Provide support for the development of bids and proposals for new business.
•  Represent clinical data management in client meetings and presentations.
•  Provide direct daily supervision and review work of assigned departmental employees, including entry-level supervisory staff as necessary, to ensure accuracy and to ensure adherence to pertinent departmental policies, practices, and procedures [SOPs, safety procedures and biosafety protocols.] Schedule and prioritize workload of group members.
•  Interview and select qualified exempt and non-exempt personnel. Recommend personnel actions, including hiring, and promotions. Partner with Human Resources and departmental management to assist in the handling of disciplinary issues. Draft appropriate personnel action paperwork.
•  Identify technical and supervisory training and development needs of direct reports. Assist in the development, implementation and delivery of departmental training programs; ensure that direct reports receive departmental orientation and necessary on-the-job training. Oversee maintenance of group training manual and training records.
•  Monitor performance of direct reports. Provide regular coaching and counseling. Assist in preparation and delivery of performance reviews of direct reports. Serve as mentor to entry-level supervisory staff, as necessary.
•  Review and approve time sheets. Coordinate vacation/time off schedules.
•  Recommend short-range operating objectives, organizational structure of direct reports and staffing requirements. Assist in the development of a departmental plan for backup and succession of key technical personnel.
•  Ensure optimum performance of group function. Recommend and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices.
•  Assist in the development, maintenance and communication of departmental systems and SOPs. Assist in the development and communication of job descriptions for subordinate positions.
•  Ensure that departmental equipment is maintained in good working condition and that departmental area(s) are maintained in a clean and orderly condition.
•  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.
• Experience: 6 years’ experience in clinical data management or related field. 3 years’ supervisory experience in a technical environment.
•  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.