Clinical Development Monitor - Global Pharmaceutical
Contribute to Execution of Global Clinical Trials
Expand your Career at a Major Multinational Pharmaceutical Company
- European Pharmaceutical Company
- Approx. 9 billion USD investment in Research and Development.
- Over 20 approvals across Japan, EU, US, APAC
- Performs site selection for potential sites to evaluate their capabilities for conducting a clinical trial.
- Recommends sites to participate in clinical trial.
- Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects.
- Performs continuous training for amendments and new site personnel as required.
- Retrains site personnel as appropriate.
- Performs continuous monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety.
- Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements.
- Collaborates with Clinical Study Manager and Medical Science Liaison to ensure recruitment plans and execute contingency plans, as needed.
- Play a role in the global development of innovative drugs (antibody drug, tumor immunotherapy, regenerative medicine, etc.)
- Manage investigational sites and conduct appropriate clinical trials.
- Ensure and supports overall ICH-GCP/J-GCP conformity and compliance in clinical study.
- Delivering innovative drugs to patients as quickly as possible.
- Monitoring experience in pharmaceutical industry or global CRO
- Familiar with GXP, particularly GCP
- English communication skills
- Scientific background
Opportunity to work in a world leading pharmaceutical company
Possible career progression opportunities as a CRA include:
- Clinical operations line management
- Clinical project management
- Regulatory affairs
- MSL / Medical Science Liaison
- Medical writing
- Clinical Data Management
- Quality assurance / auditing
- SMO management
- Site management and contracting