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 plans.
- Motivates team to complete high quality work efficiently.
- Schedules team workflow and allocates work to staff to meet deadlines.
- 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 requirements.
- 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 supporting documentation.
- Ensures that the highest levels of client service are maintained.
- 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 changes).
- 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 experience.
- Minimum of 5 years previous supervisory experience required.
- 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 requirements.
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