Company: Docs Global (Continental Europe)
Reference: Ref AS-020188
Closing Date: 26 Feb 17
Salary (£): Competitive
Benefits: Excellent & Comprehensive
DOCS has partnered with a highly prestigious organisation with one of the most robust pipeline within the industry. We have a great job opportunity for a Project Managers who are ready to further develop their career and enjoy working for a global organisation in their offices in Warsaw.
Roles & Responsibilities of the position
The Clinical Study Leader will plan and lead the delivery of all components of a clinical study from study specifications through study closeout activities. You will lead the study delivery team and be a key player during the whole study process and responsible for the consistency during the course of the study.
• Lead and implement globally agreed operations and Clinical Development strategies
• Lead and optimize the performance of study delivery teams
• Plan and lead activities associated with audits
• Participates in the negotiations and the selection process of external service providers
• Lead preparation and delivery of study documents
• Plan, lead and ensure appropriate training is achieved at Investigator/monitor meetings
• Contributes in steering committees, submission assembly teams, regulatory defense teams, and contribute to Advisory Boards as necessary
• Operational study level feasibility, development of recruitment strategies, and the delivery of the approved Clinical Study Protocol
• Work with Line Managers to identify resource need and secure resources from various departments to ensure flexible and timely formation of the Clinical Study Teams and progression of deliverables
• Agree on participating markets using the appropriate study allocation process
• Liaise with internal and external service providers
• Forecast and day-to-day management of study timelines, budget, materials and development of detailed study level plans and feasibility assessment
• Work with other members of the organization to share knowledge, experiences and best practices
• BA/BS/BSc in the life science
• Solid background in Clinical Operations Project Management
• Previous management experience of direct reports, study teams, etc
• Broad experience working in clinical research (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Organizational skills and an efficient and strong work ethic
• Problem solving mentality and ability to troubleshoot should issues arise
• Experience in oversight of outside clinical research vendors (CROs, central labs, imaging vendors, etc.)
· Office based work, no travelling
· Work in the unique organization in Poland with global R&D clinical team
· development opportunities with rapid growing organization
Please contact Dariusz Sternlicht, Recruitment Consultant at DOCS on +48 606 130 397 or email your up-to-date CV to: email@example.com
DOCS provides global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical trial industry.
Study Manager, Study Leader, Project Management, Study Conduct, Regulatory, Pharmaceutical, CRO, Pharma, Contract Research Organisation, Biotech, Medical Device, Health, Biotechnology, Chemistry, Permanent, Warsaw, Poland
2 Globeside, Globeside Business Park
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