Job Overview:
Covance by Labcorp is looking for it's next Manager External Data Management for our FSP Sponsor dedicated department.
This role is fully remote and can be based anywher in EMEA.
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.
Duties and Responsibilities:
Ensure all work is carried out in strict accordance with the relevant protocols, Standard Operating Procedures, and in compliance with Good Clinical
Performs supervisory duties including but not limited to interviewing, hiring, training, intervention, discipline, and discharging of
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
Schedules team workflow and allocates work to staff to meet
Overall responsibility for assuring timeliness and quality of work for studies for entire
Ensures that staff levels are adequate in quality and quantity to meet the forecasted 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
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
Ensure that the highest levels of client service are
Coordinate receipt, inventory, accountability and disposal of study related
Ensure all appropriate documentation and procedures are performed upon project
Keep senior management and/or client services informed of pertinent project or client related information (i.e., work scope changes).
Assist Director of Pharmacometrics in preparing proposals and attend client meetings as needed.
Assist QA and Client Services with client visits and interactions as
Liaise with Quality Assurance regarding regulatory compliance of study conduct and sponsor audits.
Perform other related duties as
Education/Qualifications:
BS degree in Science/Medical
Experience:
Previous experience of clinical research or drug development related
Previous supervisory experience
Knowledge of GCPs and regulatory agency
Familiarity with pharmacokinetics, pharmacodynamics, and medical terminology is
Skilled in the use of data management software application(s) (e.g. Oracle Clinical, PhaseForward Inform, or Medidata RAVE) and general computer
Additional experience may be substituted for education
