Clinical Research Manager

Job Description

  1. Assume overall responsibility for the preparation of protocols and Case Report Forms, finalisation of monitoring and data management options (either in-house or contracted to a Contract Research Organisation), Ethics committee approval, development of recruitment strategies to increase patient randomisation into the trial, the provision of clinical trial materials, and management of the trial.
  2. Ensure that all aspects of GCP are complied with at all times through provision of training at start-up and initiation meetings for clinical trials and on-going SOP development.
  3. Coordinate the smooth monitoring of all trials by identifying and managing qualified staff, establishing audit procedures and ensuring that cleaned data is entered into the database in a timely fashion.
  4. Participate on corporate global clinical research teams ensuring that colleagues are updated on all relevant issues.
  5. Ensure the smooth running of the clinical research department by developing systems to track projects including all study, investigator and ethical review board information, patient recruitment activity and financial management.
  6. Have responsibility for the financial management of the clinical trial programme including budget planning, resource allocation and preparation of quarterly reports.
  7. Training of sales representatives at cycle meetings and product launches.
  8. Coaching of CRAs in various aspects of management (eg HR, budgets, resource allocation) that are relevant to particular project issues.
  9. Implement training programmes for CRAs and other clinical staff with topics that include: principles and practices of project management, team communication, computer software and IT training, protocol and CRF writing, adverse event reporting and the importance of pharmacovigilance, and budget control and reporting.