Clinical Trial Specialist - MASTER

Recruiter
DOCS Global
Location
Bedfordshire
Posted
17 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Roles & Responsibilities of the positionThe 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 OfficeJob Requirements• 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 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 ManagementRemuneration & other details• Permanent contract of employment • Full-time • 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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