Ref #: 29571

Employment type: Permanent - Full-Time

Location: Buckinghamshire

Posted: 28-May-2021

Description

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 Southampton (Hampshire / 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
#pmjob