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Job Details

Global Study Associate Manager

Company: Docs Global (Continental Europe)
Location: warszawa,Poland
Reference: Ref AS-023986
Closing Date: 15 Aug 18
Type: Permanent
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

DOCS is supporting highly prestigious and one of the world’s top pharmaceutical company that is bringing innovative ideas, products and services continuously improving people’s health. This is a fantastic opportunity for an experienced clinical research professional that is ready to take on a new challenge, further develop their career and enjoy working culture in vibrant Client's office in Warsaw.


Roles & Responsibilities of the position

• Monitor study conduct and progress, proactively identifying to and resolving with the Global Study Leader, issues which may impact delivery of the study or to the necessary quality, timeline or budget objectives
• Coordinate operational aspects of AZ and Investigator Sponsored studies from SS/Proposal through CSR/Publication.
• Lead and/or participate in activities that ensure quality, consistency and integration of study data to agreed time, cost and quality objectives
• Support the study delivery team and Clinical Advice and Assurance (CA&A) in the development of and implementation of audits and regulatory inspections
• Establish and maintain interactions with key stakeholders including the facilitation of communications with MCs, Strategic Partners, Academic clinics and investigational study sites, as appropriate, and external service providers (Third Party Vendors) to identify and resolve operational feasibility issues, facilitate study start-up activities, and ensure Operations deliverables to time, budget and quality objectives
• Implement globally agreed Operations and Clinical Development strategies including processes and use of technical systems related to Operations
• Contribute to protocol development and the development of other Operations documents as appropriate as well as any updates/amendments to those documents
• Interface with Data Management Center representatives/Data Management Department, to facilitate the delivery of study data
• Provide input and review data management deliverables (e.g. eCRF specification, Data Validation Specification, Data Management Plan)
• Lead the preparation of study documents as delegated by Clinical Development Manager ( e.g. Informed Consent Form, Clinical Study Agreement, Patient Participation Card etc)
• Ensure timely entry and/or update appropriate information into tracking and communication tools (e.g. IMPACT, ISSIS and Clinical Partners Portal)

Job Requirements

- Experience working on clinical studies as a Clinical Research Associate (CRA), InHouse/Remote CRA or a Project Specialist across different phases of drug development
- Excellent knowledge of spoken and written English
- Proven organizational and analytical skills
- University degree in science preferably in medical, biological, or health related sciences, or equivalent work experience in directly related fields
- Understanding of the clinical study and drug development process and GCP/ICH guidelines in relation to Study delivery operational activities

Remuneration & other details

What is offered
We offer:
· Office based work, no travelling
· Work in the unique organization in Poland with global R&D clinical team
· 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:

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, CRA, I-House CRA, Remote CRA, CMA, Clinical Monitoring Associate, Project Specialist, Project Associate, Global CTA, Global Clinical Trial Assistant, Project Management, Study Conduct, Regulatory, Pharmaceutical, CRO, Pharma, Contract Research Organisation, Biotech, Medical Device, Health, Biotechnology, Chemistry, Permanent, Warsaw, Poland

Apply for this job: Global Study Associate Manager

Contact Information:

Address:  Head Office
2 Globeside, Globeside Business Park
Website:  Visit Our Web Site

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