Location: Bulgaria
Job Ref : AL/HQ00007937
Join a market leader within the clinical research industry and be part of a professional team.
As a Clinical Study Manager you would manage the execution of the clinical component of large, complex study protocols or global projects in accordance with the scope of work, contracted timelines and study budget. This involves the management of clinical study set-up through to the ongoing tracking and review of the study progress and reporting to relevant members of senior management.
Responsibilities
- Collaborate with other functional groups within the company such as data management, pharmacovigilance, and biostatistics where necessary to support milestone achievement and to manage study issues and obstacles.
- Provide ongoing training and support to the clinical team, including the mentoring of less experienced Clinical Team Leaders. Establish study tools and training materials. Conduct frequent team meetings and ensure regular communication.
- Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA team.
- Develop the risk management plan from a clinical perspective and coordinate clinical issue escalation and resolution with the Project Manager. Develop proactive contingency plans to mitigate clinical risk.
- Identify quality issues within the study through regular review of the clinical team communications including site communications, monitoring visit reports, data flow information and quality assurance audit findings. Implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.
Requirements
- In depth knowledge of, and skills in applying, applicable clinical research regulatory requirements
- Bachelor's degree in a health care or other scientific discipline or educational equivalent
- significant experience working on clinical trials including monitoring as well as previous experience in a project leadership role with expanding cross-regional/global focus
- equivalent combination of education, training and experience.
For further information please contact
Alina Lapadatu
Email: alina.lapadatu@hayspharma.com
Services advertised by Hays Pharma are those of an Agency and/or an Employment Business
This job was posted 30+ days ago, and has expired.
