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Job Details

Country Study Manager

Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Reference: LD9583
Closing Date: 16 Dec 17
Type: Full Time
Salary (£): Negotiable

Job Summary:

Our client, a leading global pharmaceutical company, is currently recruiting for a Country Study Manager.


Our client, a leading global pharmaceutical company, is currently recruiting for a Country Study Manager.

The Country Study Manager (CSM) provides leadership and local strategic planning and organization skills to ensure the effective and efficient delivery of operational aspects of one or more studies through all phases of study management (preparation, conduct, close-out), in accordance with the appropriate quality standards including ICH/GCP/GPP standards, company SOPs, local operating guidelines and local requirements, as applicable. 
Global/Regional Studies (referred to in rest of this document as Global), the CSM leads and has full accountability (time, quality, cost) of all Affiliate related aspects of a study and ensures delivery of country/regional operational aspects in alignment with the study plans provided by the global Study Management Team (SMT). 
Local Studies, the CSM acts as study leader and, in addition to the above, provides the leadership and clinical operational expertise for local study team.

Study Preparation Phase: 
•    Leads and participates in the preparation phase of the study (feasibility, site selection, initiation) 
•    Provides support and expertise for regulatory and ethical submission. 
•    Conduct ethical and administrative submissions, as required. 
•    Maintain up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation
•    Accountable for ensuring investigator site recruitment targets and timelines are realistic 
•    Accountable for the development of the local Affiliate’s study budget, initial study resourcing forecasts and establishment of study level plans. 
•    Accountable for ensuring that TMF (country and site level) documentation is Inspection Ready 
Study Conduct Phase: 
•    In accordance with the overall project plan, manages and maintains accurate country/study level plans (i.e. timelines, budget, resource, risk and quality plans) in appropriate company planning system. 
•    Develops and maintains effective working relationships. 
•    In conjunction with the Local Head of clinical operations, Study Start up Specialist,( SSUS) Medical Manager (MM), Medical scientific Liaison (MSL)  and or the Country Medical Director (CMD), ensures relationships with key investigator sites, alliance partners and/or collaborative groups are optimized to ensure efficient and smooth conduct of the study.
Study Close-Out:
•    Ensures all activities related to site/study close-out are managed according to global and local processes. 
Manages either directly or indirectly knowledge sharing activities via debriefs or other focus group activities. Act as a Study Start up Specialist where required on applicable studies.

    Person/Skills Profile
•    Science Degree or Nursing / Pharmacy qualification or equivalent.
•    Leadership: developed through leading multi-functional matrix study teams through all stages of clinical studies 
•    Project Management: including implementation of risk management plans and management of complex study budgets and resourcing plans 
•    Communication: excellent written and verbal communication skills demonstrated by the ability to present clear messages from complex information/data to all levels in the organization 
•    Personal Organization: demonstrated ability to prioritize and manage multiple tasks, self-motivated and achievement driven. 
•    Good knowledge of ICH GCP, GPP, company SOPs/Guidelines and quality standards related to study management. 
•    Clear and accurate communication in written and spoken English. 
•    Strong computer skills. 
•    Clinical development experience on the operational aspects of conducting clinical studies including: 
o    vendor/CRO resource management 
o    leading/working as part of a development team implementing clinical development plans 
o    risk management 
o    coordinating study level activities to deliver data for filing or publication purposes including interaction with local Business Units 
•    Demonstrated ability to interact with different professional levels of the research community 
Experience of influencing and negotiating at all levels to achieve team delivery

If you are interested in applying for this role please call Linda on +353 1 2784671 or email 
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group.

Apply for this job: Country Study Manager

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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