CTs / Clinical Trial Specialist / Hampshire / England

Employer
DOCS Global
Location
Hampshire (GB)
Salary
Career scope to develop / market-leading salary / training
Closing date
10 Oct 2020

View more

Discipline
Clinical Research, Clinical Administrator, Clinical Research Associate, Clinical Trials Manager / Administrator, Study Site Coordinator, Study Start Up
Hours
Full Time
Contract Type
Permanent
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CTS /  Clinical Trial Specialist

DOCS is looking for talented and motivated candidates to join a global study management FSP team and be part of a long-term and dynamic project.

The ideal candidate will have clinical trial experience ideally as a Senior CRA experience gained within the clinical research industry on commercial clinical trials.  We could also consider other candidates within the clinical trial coordination or study management arena.

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
  • Proactivity

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 Marlow 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 Now in Word format.

  • *Applicants who have not had a response within two weeks should assume their application has been unsuccessful.

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 development industry. 

 

Our Values

At DOCS, we are driven by our core values that guide our culture and support our goal to become a Trusted Partner. Our five core values are:

OUR PEOPLE: We attract, source, develop and retain the best talent to enables us provide world-class people and solutions for our clients.

EXCELLENCE: We never stop looking for new, better ways of working.

ACCOUNTABILITY: We take responsibility for our actions, owning our client’s problems and proactively looking for solutions.

INTEGRITY: Becoming a trusted partner means being honest, respectful and ethically sound, at all times.

OPENNESS: We encourage and facilitate an open and inclusive environment for a diverse global network of employees and stakeholders.

Contact Us
  • 2 Globeside
  • Globeside Business park
  • SL7 1HZ
  • United Kingdom
  • +44 (0) 2380 688500
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