Company: Docs Global (Continental Europe)
Reference: Ref AS-019213
Closing Date: 23 Oct 16
Salary (£): Competitive
Benefits: Excellent & Comprehensive
A Site Manager is the person in Trial Co-ordination and Site Management that serves as primary contact point between the sponsor and the investigational site. Site Manager is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through data-base lock.
Roles & Responsibilities of the position
• Management Clinical Trails according to the protocol and ICH GCP, standard operation procedures and monitoring plan.
• Knowledge and understanding of the protocol and CRF content
• Keeping contact with the Investigator.
• Supporting sites with all issues concerning study.
• Providing information to investigators about: protocol principles, study timelines, enrolment expectations and proposed fee.
• Preparing and performing Initiation Visit and Monitoring Visit according to the GCP and monitoring plan.
• Preparing Institution and Investigator fees documentation.
• Life Science Degree
• Solid understanding of clinical trial design, trial execution and operations.
• Knowledge of international standards (GCP/ICH), international (FDA, EMEA) and local regulations.
• Expertise in communication, managing multiple priorities and computer literacy.
• Proven people management skills with demonstrated expertise in working in a team.
• Fluency in English
• Availability to travel at least 60% fly and drive and should possess a valid driving license.
• A challenging CRA role in an international Pharmaceutical company.
• Permanent office based position in a stable organization.
• You will enjoy highly competitive compensation and an exceptional benefits package (fitness reimbursement, medical coverage, car allowance / company car)
This is an exceptional opportunity within a global organisation who offers rewarding careers. If you want to be a part of this exciting opportunity who offers a competitive salary, excellent benefits package, please contact Marta Marchlewska, Recruitment Consultant at DOCS on +48 664 490 059 or email your up-to-date CV to: Marta.Marchlewska@docsglobal.com
DOCS is a leading provider of global resourcing solutions to the biopharmaceutical and medical device industries. As part of ICON plc, we have the global capabilities, operational excellence and flexible approach to meet our customers’ evolving drug development needs. Our full-spectrum strategic resourcing solutions include Permanent Hiring Solutions; Contingent Resourcing; Program In-sourcing; Strategic Capacity Management; Functional Service Provision (FSP); and Hybrid Service Delivery. This comprehensive spectrum is underpinned by our unique delivery platform, which enables us to offer world-class solutions to our customers who range from small biotech's to the world’s largest pharma companies.
Pharma, Pharmaceutical, Biotechnology, Biotech, Permanent, Clinical Research, Site Manager, Clinical Research Associates, CRA, Warsaw, Poland
2 Globeside, Globeside Business Park
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