Country Study Manager- Contract

Location
Hertfordshire, England
Salary
Negotiable
Posted
Sep 22, 2016
Closes
Oct 20, 2016
Ref
sd-cstudyman
Contact
Sabrina Deo
Result Type
Jobs
Position Type
Contract
Hours
Full Time

Country Study Manager- Contract

Clinical Operations- Pharmaceutical- Hertfordshire- Contract- project management

I am currently working with a Top 10 Pharmaceutical company based in the Hertfordshire area who are looking for a Country Study Manager to join them on a 6 month contract.

They are looking for professionals who can provide leadership to one or more study teams and provide local project planning and management to achieve study completion.

As a Country Study Manager you will:
Leadership
*Builds effective, high performing study teams through influence, integration, motivation and optimization of team performance
*Sets the study team goals and ensures goals are in line with the operational strategy
*Manages and coaches performance of study team members
*Develops and maintains effective working relationships with, and is the primary contact for, key stakeholders
*Maintains awareness of external clinical research practices
Planning
*Responsible for protocol development in conjunction with medical advisor and external investigator
*Analyzes results of protocol and site feasibility testing, and provides country feedback or recommendations to local and/or global study teams
*Develops scenario plans that delivers quality studies on time, with the most efficient use of budget and resources
*Develops and manages UK budget/financial plan, and forecasts using appropriate tools, ensures the study team has the appropriate resources to effectively deliver high quality studies on time and within budget
Delivery
*Is accountable for all UK ethical and administrative submissions for protocols and subsequent amendments for sponsored studies and investigator guidance for supported studies
*Provide support and liaise with UK regulatory for submissions of protocols
*Design and implement a country level training plan to ensure that team members and investigators receive training on the protocol, ICH/GCP requirements
*Ensures patient safety and quality are maintained
*Leads the evaluation of standards across one or more study teams
*Maintains oversight and ensures consistency across studies within a project

An ideal Country Study Manager will have:
*Degree- medical/science related
*Strong leadership skills
*Project management experience- implementation or risk management plans and study budgets
*Excellent knowledge of ICH GCP and the EU Clinical Trials Directive and the legal and regulatory requirements for the conduct of Clinical Trials in the UK

If you are interested in this opportunity and wish to discuss further details about the role please contact Sabrina Deo at +44 (0)121 616 3471

Keywords:
Clinical, operations, project, manage, study, trials, budgets, contract, pharmaceutical, UK, Hertfordshire, protocol, ICH GCP, regulatory guidelines, medical, science, planning

Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.

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