Company: CK Clinical
Location: Welwyn Garden City
Closing Date: 08 Dec 16
Salary (£): 100,000+
Lucy Stendall is recruiting for a Global Study Manager in Neurology to join a leading Pharmaceutical company based in Welwyn Garden City, on a full...
Lucy Stendall is recruiting for a Global Study Manager in Neurology to join a leading Pharmaceutical company based in Welwyn Garden City, on a full time, temporary basis for 12 months.
As a Global Study Manager, you will be responsible for providing operational expertise and leadership to one or more clinical operations teams to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of Clinical Study Management (Plan, Initiate, Conduct, Close), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.
Further responsibilities of this Global Study Manager position will include:
- Developing operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.
- Building effective and efficient high performing operations teams and ensuring team members are aware of their accountabilities, responsibilities and deliverables.
- Developing and maintaining effective working relationships with SMT members, with particular focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams.
- In collaboration with functional management, coach, mentor, support, and provide study specific direction to Study Management team members.
- Ensuring operational tracking tools are identified, including systems to meet the needs of the operations team and ensuring reporting to the GSL.
- Establishing study milestones and ensuring accurate tracking and reporting of study metrics.
- Leading the creation of the study level patient recruitment plan and retention strategies based on feasibility data and input from the affiliate teams and consultation with the GSL and OPL.
- Providing operational input and insight into all study related documentation (including protocol and informed consent form) and processes
- Analysing the feasibility data across countries with input from the affiliates and making recommendations to the GSL for the strategic country and site distribution and patient numbers.
- Overseeing the forecasting and management of clinical/non-clinical supplies; designing drugs assumption and supply chain process.
- Delivering the operation elements of the study plan; Chairing operations team meeting and organising the investigator meetings, monitoring training, CRO kick-off meetings.
- Proactively managing actual study level recruitment versus planned patient recruitment status and communicating variance to the GSL and implementing contingencies in consultation with the GSL.
- Primary contact with affiliates to maintain oversight of performance, issues, and their resolution and identify systematic issues and coordinate any corrective action.
- Providing the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work; developing and executing appropriate site and CRO/vendor audit and quality plans.
As a Global Study Manager, you will have the following qualifications, skills and experience:
- Life sciences degree or nursing equivalent or substantial experience in a clinical research/a healthcare environment.
- Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a Global environment and/or including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock.
- Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans.
- Good knowledge of ICH GCP
- Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.
- Experience of working as part of a large team and leading small study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitments.
- Well developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization.
CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL37531 in all correspondence.
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