My client is seeking an experienced Clinical Trial Manager who will be involved in involved in the regional management on Phase Ib-III clinical studies, with a strong emphasis on the EMEA region.

Essential Duties and Job Functions

• Provides regional management of global PIb-III studies managed by Clinical Program Manager
• Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports
• Maintains study timelines
• Contributes to development of study budget
• Contributes to development of RFPs and participates in selection of CROs/vendors.
• Manages CROs/vendors
• Coordinate's review of data listings and preparation of interim/final clinical study report
• Ensures effectiveness of site budget/contract process
• Train CROs/vendors/investigators/study coordinators on study requirements.
• Conducts Monitoring/co-monitoring as required
• Assists in determining the activities to support a project's priorities within functional area
• Coordinates and supervises all aspects of a clinical study
• Contributes to Clinical Operations International team activities & initiatives
• Collaborates with local medical affairs colleagues on country specific studies and initiatives

Specific Responsibilities

• Works with Clinical Program Managers to manage regional component of Virology clinical trials and/or the entire process of a local clinical trial, with the ability to identify issues and adapt to changes
• Interacts with cross-functional teams internally and externally to ensure trial progress
• Will incorporate study logistics and planning to accomplish study objectives
• Will serve as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems

Experience and Skills

• Significant relevant experience and a BSc or nursing qualification in a relevant scientific discipline
• Previous experience in Virology areas would be advantageous but not essential
• Must have previous study management/coordination experience at Sr CTMA level
• Monitoring experience is highly desirable as co-monitoring will be required
• Thorough knowledge and understanding of FDA and EU Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable
  
  

Parkside Recruitment Ltd is acting as an Employment Business in relation to this vacancy. Parkside Recruitment is an Equal Opportunities Employer.