Company: Docs Global (Continental Europe)
Reference: Ref AS-020301
Closing Date: 20 Feb 17
Salary (£): Competitive
Benefits: Excellent & Comprehensive
DOCS has partnered with a highly prestigious biotech organisation with one of the most robust pipeline within the industry. We have a great job opportunity for candidates with previous clinical trial experience who are ready to further develop their career and work on a global level.
Roles & Responsibilities of the position
Role and Responsibilities:
The Clinical Trial Assistant (Global) participate in the coordination of, and contribute to operational activities to ensure quality and consistency of clinical operations deliverables to time, cost, and quality objectives from Study Specifications through study close-out activities and Clinical Study Report.
• Contribute to clinical study start-up, execution, close-out and reporting
• Collect, review and track regulatory and other relevant documents. Interface with Investigators, Strategic Partners, Marketing Companies and internal staff during the collection process to support effective delivery of a study and its regulatory documents through finalization of the Clinical Study Report
• Initiate and lead the set-up of the Study Master File including tracking of documents. Maintain and close the SMF ensuring ICH/GCP compliance
• Initiate and maintain production of study documents, ensuring template and version compliance
• Create and/or import clinical-regulatory documents into the Global Electronic Library
• Contribute to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e. Submission Ready Standards, supporting effective publishing and delivery to regulatory authorities
• Plan and proactively collate the administrative appendices for the Clinical Study Report
• Interface with Data Management Centre and/or Data Management representatives to facilitate the delivery of study related documents
• Provide input into non-drug project work including training activities and development of procedures as needed
• Set-up, populate and accurately maintain information in tracking and communication tools (e.g. IMPACT, eRoom) and support others in the usage of these systems
• Manage and contribute to coordination and tracking of study materials and equipment
• Coordinate administrative tasks during the study process.
• University degree, preferably in medical, biological, or health related sciences, or equivalent work experience in directly related fields
• Proven organizational and analytical skills
• previous experience on an administrative/study coordinator role within clinical trials field
• Computer proficiency
• Excellent knowledge of spoken and written English
What is offered
· 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.
Clinical Trial Assistant, Clinical Trial Administrator, CTA, 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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