Clinical Research Manager
- 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.
- 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.
- 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.
- Participate on corporate global clinical research teams ensuring that colleagues are updated on all relevant issues.
- 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.
- Have responsibility for the financial management of the clinical trial programme including budget planning, resource allocation and preparation of quarterly reports.
- Training of sales representatives at cycle meetings and product launches.
- Coaching of CRAs in various aspects of management (eg HR, budgets, resource allocation) that are relevant to particular project issues.
- 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.
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(03) 9938 7100