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Global Study Manager



Business Type: Pharmaceutical Company, Biotechnology Company, Clinical Research Organisation
Job Type: Biotechnology, Clinical Study- Trials
Job Level: Experienced (non manager)
Position: Full Time
Location: USA - Massachusetts
Reference: GCM2205
Closing Date: 16/06/17
Background:
Position: Global Study Manager
Contract type: Fulltime permanent
Location: Boston

An international Biotech company which is at the forefront of developing therapeutic and diagnostic solutions to address high unmet patient needs in metabolic and inflammatory diseases, with a particular focus on the liver and gastroenterology is seeking a Global Study Manager to independently oversee clinical studies from concept to close-out.

The Global Study Manager will be responsible for ensuring successful delivery of key study deliverables within timelines and budget. The ideal candidate will be highly adaptable and a proactive problem-solver with the ability to work within multi-functional teams and to critically evaluate and manage timelines and key deliverables.

Responsibilities but not limited to:

*Provides direction and leadership to one or more clinical operations teams
*Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.
*Builds effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables.
*Creates team culture and promotes team spirit.
*Develops and maintains effective working relationships with affiliate teams, external CRO (for outsourced teams) and co-development partner study teams.
*Contributes to the development and management of the study timelines, resources, budget, risk and quality plans
*Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the Senior Director.
*Develops and manages clinical study budgets.
*Establishes study milestones and ensures accurate tracking and reporting of study metrics.

Requirements:

*BA/BS and 10 years of pharmaceutical/CRO experience with a minimum of 5 years of study management experience managing complex international clinical studies.
*Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans.
*Minimum of 1 year of independent monitoring experience as a CRA
*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.

For more information regarding this position please contact me on 0044-2072556638, alternatively please email me on Vamsi.gentela@secpharma.com


Posted: 19/05/2017 | NPJ Ref: 186394
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