Assoc Dr. Clinical Scientist - Oxfordshire - £70K+

  • Job Reference: 25241557-2
  • Date Posted: 12 January 2017
  • Recruiter: Vivid Resourcing Limited
  • Location: Oxfordshire
  • Salary: £70,000
  • Bonus/Benefits: + DOE
  • Sector: Healthcare & Medical
  • Job Type: Permanent

Job Description

A client I am currently working with is looking for an Associate Director Clinical Scientist to join them on a Permanent basis at their site in Oxfordshire.

Key Responsibilities:

- Support study design, translate scientific imperative into operational delivery of trials. Review and/or writing of study concept, protocol, study plans, IP management plans, CSRs
- Lead the cross-functional Study Conduct Team - drive operational delivery and facilitate issue resolution
- Plan timelines, conduct study feasibility, risk assessment/management and contingency planning. Ensure timelines are communicated to all personnel assigned to the study (including vendors)
- Plan and/or conduct site evaluation and initiation; develop and maintain effective relationships with clinical sites globally
- Provide guidance on protocol and procedures in the development of eCRF design
- Review monitoring visit reports; liaise with monitors to understand any trends on data management issues/ICF issues/study binder issues/site staff issue to develop solutions
- Review clinical trial data - monitor data quality and ensure appropriate quality measures are in place
- Ensure consistency of study execution across studies to facilitate data analysis and regulatory filing
- Study specific vendor interaction and coordination
- Liaise with clinical drug supply/manufacturing to ensure co-ordination for trial subjects
- Maintain TMF and ensure inspection readiness
- Proactive stakeholder management and communication of progress and issues

Minimum Requirements:

- Minimum of a BA/BS in Life Sciences Degree
- Previous leadership in a matrix environment
- 7+ years of industry-sponsored clinical trial management experience required. Experience with biologics or cell and gene therapy is a plus
- Strong knowledge of clinical operations and the regulatory process - experience independently running/managing multiple clinical trials preferably within the oncology area
- EDC including trial management, data review, issuing and resolving queries, CRF design/review/ approval
- Prior experience with clinical protocol development and/or regulatory submissions and management

Vacancy Summary:

Job Type: Permanent

Location: Oxfordshire (Part time Remote)

Salary: £70K + DOE

If you are interested in this role or know anyone who might be please get in touch with an up to date CV or give me a call on *********** to discuss further.