Global Study Manager / Permanent / UK
- Experience Level
Clinical Trial Manager (Global Studies)
- Do you have experience of managing international commercial clinical studies within a CRO or pharma setting?
- Can you demonstrate strong planning and management skills to meet study deliverables and budget?
- Do you have global study oversight experience?
- if you do, please apply now.
The Clinical Trial Manager key responsibilities will include:
- Planning and management of clinical studies conducted by global development team through the leadership of the cross-functional clinical study team
- Contributing to study-level risk assessments
- Leading and continually review risk mitigation activities to ensure study delivery to plan
- Identifying and resolving issues at a global level
- Reporting study progress at appropriate forums and to management
- Collaborating with Regional Clinical Trial Manager to ensure country level study delivery aligned with global delivery plans
- Overseeing global insourcing/outsourcing partner deliverables to the required standards
- Managing study-level budget and timelines
- Partnering with Tech Services, Supplier Governance and Electronic Trial Operations - to ensure vendor set-up, conduct and quality oversight of deliverables
- Leading global study-level documentation and required tool and systems set-up
- Leading development and implementation of global Drug Supply Plan
- Ensuring implementation of study(ies) in accordance with SOPs and ICH/GCP guidelines
What is required
- BA/BS/BSc or RN
- Previous experience of project managing international/global commercial studies within the clinical research industry, i.e. within pharma, CRO or biotech working environments
- Previous study management/clinical project management as a Clinical Trial or Clinical Study Manager
- Experience in overseeing external clinical research vendors (CROs, central labs, imaging vendors, etc.) highly preferred
- Project management experience including oversight of study deliverables, budgets, and timelines
- Ability to use scientific and clinical knowledge to conceptualize study designs
- Experience anticipating and resolving problems
- Experience writing and presenting clearly on scientific and clinical issues
- Experience collaborating and leading cross-functional teams (team/matrix environment)
- Knowledge of project risk management assessment and mitigation approaches
- Full-time availability
- Full and valid UK working eligibility
- Full and valid driving licence
- Ideally able to start ASAP/negotiable
What is offered
- Permanent contract of employment with DOCS seconded to the client;
- Office-based near Southampton (Hampshire) with the flexibility of up to 2 days’ home-working per week.
- Competitive salary depending on level of skills and experience;
- Company benefits: 25 days annual leave, car allowance, bonus, pension and healthcare.
Why Join DOCS?
If you are an experienced clinical study/trial manager looking for a new career opportunity with a rapidly growing and fast paced global leader, please send your CV today to me or for more details: Elisabeth.Knighton@docsglobal.com or ring +33 964 25 67 65.
*Applicants who did receive a response within two weeks should assume their application has been unsuccessful*
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