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Job Details

Clinical Trial Specialist

Company: DOCS Global
Location: Marlow,United Kingdom
Reference: Ref AS-016499
Closing Date: 05 Dec 16
Type: Contract
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

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.

Requirements:

Roles & Responsibilities of the position

• Support the management and oversight of Global Clinical Trials
• Coordinate, author and manage preparation of clinical trial documentation
o Training Materials for CRAs/CTAs
o Investigator Meetings
o Site Evaluation and Initiation Training
o COV training
• Managing process for planning and procuring and oversight of ancillary clinical supplies
• Supporting global recruitment and retention initiatives
o Authoring global/country level recruitment plans
o Authoring global/country level retention plans
o Authoring and distribution of Study Newsletters
• Maintaining study level storyboard for critical timelines
• Facilitating authoring of Investigational Product Information Manual and study specific Important Protocol Deviation (IPD) list
• Vendor management
• Compiling IRB/EC submission documentation
• Assisting with Operational Review preparation
• Preparing Clinical Study Team meeting agendas and minutes
• Managing global versioning and distribution of informed consent forms (ICFs)
• Facilitating cross functional meetings
Critical Success Factors for the Role include:
• Indepth knowledge of drug development process
• Experience in or familiar with advanced concepts of clinical research
• Demonstrated success in a CRA or study management related role
• Extensive knowledge of technical, scientific and medical information
• Advanced computer skills
• Detailed knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
• Ability to write and present clearly using scientific and clinical issues terminology
• Experience dealing with time demands, incomplete information or unexpected events
• Excellent communication skills
• Good organizational and planning skills
• Experience working effectively in a team/matrix environment
• Proactivity

Job Requirements

• BA/BS/BSc or RN
• Specialist experience working in life sciences or medically related field
• CRA experience preferable
• 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
• Ideally able to start to start before May 2016

• Key Competencies:
• 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

Remuneration & other details

What is offered
• Permanent contract of employment
• Full-time
• Office-based in Marlow (Bucks) or near Southampton (Hampshire)
• Market leading salary ranging depending on level of skills and experience, plus company benefits (23 days annual leave, pension, healthcare cover, etc.)

Apply for this job: Clinical Trial Specialist

Contact Information:

Address:  DOCS UK
2 Globeside, Globeside Business park Marlow
SL7 1HZ
England
Reasons to work for Docs International
Tel:  +44 (0) 2380 688500
Fax:  +44 (0) 2380 688501
Website:  Visit Our Web Site

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