Company: Docs Global (Continental Europe)
Reference: Ref AS-020187
Closing Date: 24 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 Clinical Research Associates 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 Development Associate Manager (CDAM) will lead and coordinate activities that ensure quality, consistency, and integration of global study progress. You will work with and lead cross-functionality, with internal and external partners, on global studies across different phases of drug development and different therapy areas.
• Lead and Coordinate operational aspects of clinical studies from Study Design Concept/Proposal through Clinical Study Report /Publication.
• Lead and/or participate in activities that ensure quality, consistency and integration of study data to agreed time, cost and quality objectives
• Monitor study conduct and progress, proactively identifying to and resolving with the Global PM , issues which may impact delivery of the study or to the necessary quality, timeline or budget objectives
• Interface with Data Management Center representatives to facilitate the delivery of study data
• Establish and maintain interactions with key stakeholders to identify and resolve operational feasibility issues, facilitate study start-up activities, and ensure Operations deliverables to time, budget and quality objectives
• Contribute to protocol development and the development of other Operations documents as appropriate as well as any updates/amendments to those documents
• Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and in the development of the Source Data Verification plan and other documents
• Ensure timely entry and/or update information into tracking tools
• Ensure the supply of study materials and Investigational product by liaising with Investigational Product Supply or external service providers as appropriate
• Support the study delivery team and Clinical Advice and Assurance in the development of and implementation of audits and regulatory inspections
• University degree in science preferably in medical, biological, or health related sciences, or equivalent work experience in directly related fields
• Experience working on clinical studies as a Clinical Research Associate (CRA), across different phases of drug development
• Proven organizational and analytical skills
• Understanding of the clinical study and drug development process and GCP/ICH guidelines in relation to Study delivery operational activities
• Excellent knowledge of spoken and written English
· Office based work, no travelling
· Work in the unique organization in Poland with global R&D clinical teams
· 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: firstname.lastname@example.org
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.
Clinical Research Associate, 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
|Website:||Visit Our Web Site|
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.