CTS / Clinical Trial Specialist / Hampshire / England
- Experience Level
- Experienced (non-manager)
CTS / Clinical Trial Specialist
DOCS is looking for talented and motivated candidates to join a global study management FSP team and take part in a long-term and dynamic project.
The ideal candidates will ideally bring Senior CRA experience gained within the clinical research industry on commercial clinical trials. This is an excellent career opportunity for an experienced CRA to move towards clinical study management. We could also consider candidates with solid multi-country clinical trial coordination from CROs or pharmaceutical companies.
Key CTS 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:
- Global/country level recruitment and retention materials
- 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
- Advanced Microsoft Office skills. Demonstrable understanding of pivot tables and use of advanced Excel formulae would be a distinct advantage.
- Detailed knowledge of Good Clinical Practice (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
- Ability to write and present clearly using scientific and clinical 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
What is required
- Ideally a minimum of 2 years’ experience gained within the clinical research industry on commercial clinical studies within a CRO, pharmaceutical or biotech working environment
- CRA/clinical trial monitoring experience preferred
- Proactive, flexible and problem-solving work approach with strong policy, process and procedural conformance
- BA/BS/BSc in life sciences or RN
- Full-time availability
- Full and valid UK working eligibility
What is offered
- Permanent full time contract of employment with DOCS seconded to the client
- Structured 4-week training for all new starters
- Office-based in Eastleigh near Southampton (Hampshire) with the flexibility of up to 2 days’ home-working per week.
- Salary depending on level of skills and experience plus company benefits (23 days’ annual leave, pension, healthcare cover, etc.)
Why Join DOCS?
If you are an experienced clinical trial professional looking to join a growing and dynamic team, this would be the right role for you. To express your interest please send your CV today 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.
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