Snr / Global Clinical Study Manager / s
ProClinical is seeking Global Clinical Study Manager / Senior Global Clinical Study Managers to be based in Cambridge or Uxbridge. The Global Clinical Trial Manager (GCTM) role is the lead of the cross-functional Clinical Study Team responsible for successfully delivering our exciting and innovative clinical trial portfolio on time and on budget. You will achieve this through close collaboration with study team members, driving effective decisions and proactively identifying opportunities as well as risks and their mitigations. In this highly rewarding role, no day will be the same. The company's product pipeline covers many Therapeutic areas, including: Oncology, Haematology, Bone, Neuroscience, Inflammation, Cardiovascular and Observational Research.
- Leader of the Clinical Study Team. Manage the conduct of clinical trials from study design through to close out at global level, ensuring the quality and scientific integrity of the trial in a Risk-Based Study Execution model
- Oversight of and Collaboration with cross functional stakeholders, through effective communication and proactive risk identification, management and mitigation to ensure timely and on-budget execution of clinical trial deliverables
- Leading the Clinical Study Team to drive effective decision making.
- Ensuring the conduct of studies in accordance with Regulatory Authority, company SOPs and ICH-GCP guidelines including Trial Master File (TMF) Management, ensuring inspection readiness at all times.
- Effective management of vendors to the required standards
- Lead/support global process development and improvement activities
- Travel as required to support the execution of clinical studies as required.
Skills and Requirements:
- BA/BS/BSc or RN
- Regional clinical project management experience
- Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.)
- 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)
- Global clinical project management experience
- Extensive clinical research 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)
- Knowledge of time, cost and quality metrics, Key performance indicators (KPIs)
- Ability to lead and work effectively in a global team/matrix environment on multiple projects
- Analyze data to identify trends and patterns to support mitigation activities/actions
- Critical thinking and horizon scanning
- Problem solving
- Informed decision making
- Relationship Management and influencing skills
- Organizational and planning skills
- Strong IT skills to manage internal systems and reporting
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Pike on +44 207 4400 639 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.