DOCS Global

UK Clinical Trial Manage with EU CRAs Oversight

Location
Marlow, UK
Salary
Competitive
Posted
20 Apr 2021
Closes
26 Apr 2021
Ref
28531
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
The Clinical Trial Manager main responsibilities are:
• Leading the regional matrix team (e.g. CRA, CTA, etc.) to ensure delivery of country and site level study activities in alignment with the global study project plan
• Identifying and resolving issues at a regional level
• Collaborating with Global CTM to ensure country level study delivery is aligned with the global study project plan
• Contributing to study-level risk assessments
• Leading and continually review regional risk mitigation activities to ensure study delivery to plan
• Overseeing regional insourcing/outsourcing partner deliverables to the required standards
• Ensuring regional, country and site vendor set-up, conduct and quality e.g. laboratories and equipment provisioning
• Leading regional documentation and required tool and systems set-up
• Contributing to regional aspects of Drug Supply Plan
• Ensuring implementation of study(ies) in accordance with SOPs and ICH/GCP guidelines
• Supporting audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate
• Executing regulatory agency inspection readiness activities (e.g. TMF review, story board generation) within region
• Supporting and contributing to Clinical Study Team(s)
• Ensuring relevant systems are updated to enable accurate reporting of study progress and milestone deliverables
• Ensuring key stakeholders are kept informed of study progress e.g. Global CTM, DOMs
• Contributing to development of study-specific materials e.g. monitoring plan, study specific training documents
Participation in cross-functional task forces / process improvement groups

Basic qualifications
• BA/BS/BSc or RN
• Broad experience working in life sciences or medically related field, including general biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company)

Preferred qualifications
• BA/BS/BSc in the sciences or RN
• Ideally 7 years work experience in life sciences or medically related field, including preferably 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company.
• Experience in oversight of outside clinical research vendors (CROs, central labs, imaging vendors, etc.)

What is offered
• Permanent and full time contract of employment with DOCS seconded to our client
• Office-based in Marlow (Bucks/UK) 3 days per week with 2 days homeworking flexibility
• Great scope to develop your career further
• Salary will depend on level of experience and skills
• Structured on-boarding for all new joiners with company benefits to include annual leave, car allowance, and more.

For more information, please contact me at Elisabeth.Knighton@DOCSGlobal.com
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