Company: DOCS Global
Location: Marlow,United Kingdom
Reference: Ref AS-018885
Closing Date: 23 May 17
Salary (£): Competitive
Benefits: Excellent & Comprehensive
Why Join DOCS? If you are an experienced clinical professional looking for an opportunity with a rapidly growing and fast paced global leader on an interesting and complex project this would be a compelling role for you. To express your interest please send your CV today to find out more details to Elisabeth.Knighton@docsglobal.com or ring +33 964 25 67 65. *Applicants who have not had a response within two weeks should assume their application has been unsuccessful.
Roles & Responsibilities of the position
The ideal candidate will bring experience gained within the clinical research industry on commercial clinical trials. The project will provide exposure across a variety of therapeutic areas with an organization that is at the forefront of adopting new processes and technologies, creating a unique opportunity for career growth and development. Experience as a CRA would be beneficial.
Key Responsibilities include:
• Supporting the management and oversight of global clinical trials
• Essential document management
• Maintaining study level storyboard for critical timeline oversight
• Compiling IRB/EC submission documentation
• To coordinate, author and manage preparation of clinical trial documentation and training materials (including investigator meetings, site evaluation and initiation training)
• Facilitate development of Investigational Product Information Manual and study specific Important Protocol Deviation list
• Managing processes for planning, procuring and oversight of ancillary clinical supplies
• Creation and management of study specific tools, including:
o Global/country level recruitment and retention materials
o Authoring and distribution of study newsletters
• Vendor management (including set up, tracking and issue resolution over the life of the study)
• Tracking and collation of study data and metrics utilizing multiple clinical systems
• Preparing clinical study team meeting agendas and minutes, facilitating cross-functional meetings
• Managing global versioning and distribution of documents (e.g. informed consent forms)
Critical Success Factors for the Role include:
• In depth knowledge of drug development processes
• Experience or familiarity with advanced concepts of clinical research
• Demonstrated experience gained within a clinical research environment on clinical studies
• Extensive knowledge of technical, scientific and medical terms with advanced Microsoft Office
• BA/BS/BSc in life sciences or RN
• At least 2 years’ experience gained within a clinical research environment on commercial clinical studies with advanced Excel skills
• Previous biopharmaceutical clinical research experience obtained working on industry-sponsored or industry-partnered clinical trials, or working on clinical trials at a biotech, pharmaceutical or CRO company
• Full-time availability
• Full and valid UK working eligibility
• CRA/clinical trial monitoring experience preferred
Proactivity / Attention to Detail / Teamwork / Strong Written and Oral Communication / Delivery Focus / Flexibility / Initiative / Relationship Building / Policy, Process and Procedural Conformance / Problem Solving / Time Management
• Permanent contract of employment
• Office-based in Marlow (Bucks) or near Southampton (Hampshire). Home-based working 2 days per week may be negotiable for the right candidate.
• Salary depending on level of skills and experience plus company benefits (23 days annual leave, pension, healthcare cover, etc.)
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