Ref #: 29574

Employment type: Permanent - Full-Time

Location: Buckinghamshire

Posted: 18-Jun-2021

Description

As a global study manager, you will need to demonstrate a solid clinical study management track-record across several countries and regions.

You will join a highly dynamic team of global clinical trial managers and join one of the most dynamic global study management team.

Your main 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 commercial clinical studies within the clinical research industry, i.e. within pharma, CRO or biotech working environments, ideally 5 to 7 years.
• Previous clinical study management/clinical project management as a 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 and valid UK working eligibility


What is offered
• Permanent contract of employment with DOCS seconded to the client;
• Full-time;
• The role is fully homebased in England.
• Competitive salary depending on level of skills and experience;
• Company benefits: 25 days’ annual leave, car allowance, bonus, pension and healthcare.


For more details please contact me at Elisabeth.Knighton@docsglobal.com or ring +33 964 25 67 65.

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