Your mission
Position Summary/objective:
Main responsibilities of this position will include but are not limited to the following tasks:
Essential functions:
Secondary functions:
Competencies
Main responsibilities of this position will include but are not limited to the following tasks:
- Conduct and oversight of GCP compliant planning, conduct and clinical monitoring activities in clinical trials, including but not limited to:
- Conduct and oversight of clinical trial site selection process
- Review of monitoring visit reports
- Oversight and coordination of deviations from clinical trials (Deviation Manager)
- Ensure relationship management and communication with the clinical trial sites
- Collection of clinical trial site specific documents for I
- IRB/IEC submissions according to local requirements and oversight of such
- Ensure training of clinical trial sites and associated collaboration partner
- Performance review and management of clinical trial sites
- Conduct of Sponsor Oversight Visits if clinical monitoring is outsourced
- Develop and maintain SOPs, guidance documents & training material covering monitoring aspects
Essential functions:
- Support clinical trial site feasibility
- Conduct all aspects of clinical monitoring for clinical trials including site visits for qualification, initiation, routine monitoring and close-out.
- Support the maintenance of the Investigator Site Files and Trial Master Files
- Conduct all aspects of site management as prescribed in the clinical trial specific functional plans.
- Prepare accurate and timely monitoring visit reports
- Review progress of clinical trials, especially patient recruitment and clinical trial data capture and initiate appropriate actions to achieve objective
Secondary functions:
- Maintain clinical trial tracker
- Organize and present clinical trial content at Investigator Meetings
- Act as a primary contact for clinical trial supplies and other suppliers (vendors)
- Participate in the development of Case Report Forms and clinical trial documents
- Prepare and review Standard Operations Procedures and Working Instructions as well as template documents
Competencies
- Comprehensive knowledge of ICH-GCP, FDA and EMA and applicable local regulations
- Understanding of basic medical oncology terminology and science preferable
- Very good organizational skills to work efficiently, good time management, excellent communication skills
- Good team player with excellent negotiation and conflict resolution skills
- Positive attitude and willingness to learn and contribute in a team