Manager, Data Management
Posted on: June 12, 2021
Manager, Clinical Data Management
The selected candidate will be responsible for the overall
management, administration and organization of Data Management in
Pharmacometrics. Contributes to the development and implementation
of data management business strategy. Responsible for ensuring the
efficient utilization of all human and physical resources.
- Manages a team of 6-10 people who will manage safety lab data
only. Create DTS, mapping specfications, data validation
specifications and peform data review.
- Ensures all work is carried out in strict accordance with the
relevant protocols, Standard Operating Procedures, and in
compliance with Good Clinical Practices.
- Performs supervisory duties including but not limited to
interviewing, hiring, training, intervention, discipline, and
discharging of staff.
- Coaches and mentors staff including initiating and implementing
appropriate staff development programs. Meets with staff on a
routine basis to review goals and individual development
- Motivates team to complete high quality work efficiently.
- Schedules team workflow and allocates work to staff to meet
- Overall responsibility for assuring timeliness and quality of
work for studies for entire team.
- Ensures that staff levels are adequate in quality and quantity
to meet the forecasted workload. Recommends changes if necessary
and justifies them in accordance with company policy.
- Ensures that appropriate training programs are in place so that
staff is adequately and properly trained for their job
- Ensures that all training files are up to date and complete in
accordance with SOPs and ICH/GCP.
- Organizes, chairs, and records minutes for all meetings or
delegates these responsibilities appropriately.
- Updates internal timelines for allocated projects in a timely
manner and renegotiates timelines as appropriate. Provides senior
management with updates on timelines and projects.
- Ensures mechanisms are in place to maintain flow of appropriate
information with the project teams.
- Leads the review and amendment of departmental processes and
- Ensures that the highest levels of client service are
- Coordinate receipt, inventory, accountability and disposal of
study related information.
- Ensures all appropriate documentation and procedures are
performed upon project completion.
- Keeps senior management and/or client services informed of
pertinent project or client related information (i.e., work scope
- Assists Director of Pharmacometrics in preparing proposals and
attend client meetings as needed.
- Assists QA and Client Services with client visits and
interactions as appropriate.
- Liaises with Quality Assurance regarding regulatory compliance
of study conduct and sponsor audits.
- Performs other related duties as assigned.
- BS degree in Science/Medical field.
10 years of clinical research or drug development related
- Minimum of 5 years previous supervisory experience
- Knowledge of GCPs and regulatory agency guidelines.
- Familiarity with pharmacokinetics, pharmacodynamics, and
medical terminology is required.
- Skilled in the use of data management software application(s)
(e.g. Oracle Clinical, PhaseForward Inform, or Medidata RAVE) and
general computer operation.
- Additional experience may be substituted for education
Keywords: Covance, Raleigh , Manager, Data Management, Other , Raleigh, North Carolina
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