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Job Details

Clinical Development Associate Manager (CDAM)

Company: Docs Global (Continental Europe)
Location: Warszawa,Poland
Reference: Ref AS-020187
Closing Date: 24 Feb 17
Type: Permanent
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

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.

Requirements:

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.

Responsibilities:
• 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

Job Requirements

• 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

Remuneration & other details

We offer:
· Office based work, no travelling
· Work in the unique organization in Poland with global R&D clinical teams
· development opportunities with rapid growing organization

To Apply:
Please contact Dariusz Sternlicht, Recruitment Consultant at DOCS on +48 606 130 397 or email your up-to-date CV to: dariusz.sternlicht@docsglobal.com

About DOCS:
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.

Key words:
Clinical Research Associate, Project Management, Study Conduct, Regulatory, Pharmaceutical, CRO, Pharma, Contract Research Organisation, Biotech, Medical Device, Health, Biotechnology, Chemistry, Permanent, Warsaw, Poland

Apply for this job: Clinical Development Associate Manager (CDAM)

Contact Information:

Address:  Head Office
2 Globeside, Globeside Business Park
Marlow
Buckinghamshire
SL7 1HZ
England
Website:  Visit Our Web Site

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