Country Study Manager

Welwyn Garden City
£380 - £425 per day
28 Aug 2019
27 Sep 2019
Russell Oakley
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Russell Oakley is recruiting for a Country Study Manager to join a company in the pharmaceutical industry at their site based in Hertfordshire on an initial 6 month contract basis.

The main purpose of the role will be to:
Provide leadership and regional/local strategic planning and operation delivery to assigned clinical studies through all phases of study management (preparation, study start-up, conduct, close out), in line with quality standards. For global studies you will lead and have full accountability in line with the SMT. For local studies you will act as study leader and provide leadership and operational expertise to the local study teams.


-Full accountability and oversight for all assigned studies at regional/country level in line with the overall project plan, manage and maintain accurate country/study level plans
-Highlight risks and deviations from plans to relevant parties, developing mitigation strategies where needed.
-Lead local study teams, representing country clinical operations at the Global SMT, and provide global teams with feedback from an affiliate perspective
-Plan and execute country study goals and commitments
-Serve as global country study representative, as part of global study team
-Coach and support study team members
-Provide study oversight, leadership and support to contract research organisation staff to ensure overall delivery at country and site level.
-Oversees study feasibility, site monitoring performance, preparation of risk based monitoring plans and ensures eTMF completeness and oversight of all relevant compliance activities.
-Collaborate in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and completion of CAPA for allocated studies.
-Develops and maintains optimal site relationships with key investigator sites, alliance partners and/or collaborative group for current and future studies.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
-University degree or equivalent in a medical/science-related field or nursing degree and/or 5 years proven experience in a Clinical Research/Development or related industry.
-Able to communicate clearly and accurately in both written and spoken English.
-Demonstrated ability to interact with different professional levels of the research community.
-Strong leadership skills developed through leading multi-functional matrix study teams through all stages of clinical studies.
-Proven clinical development experience on the operational aspects of conducting clinical studies which may include vendor/CRC management, leading/working as part of a development team, implementing clinical development plans and coordinating study level activities to deliver data for filing or publication purposes including interaction with local Business Units.
-Experience in project management including implementation of risk management plans and management of complex study budgets and resourcing plans.
-Experience influencing and negotiating at all levels to achieve team delivery.
-Excellent written and verbal communication skills demonstrated by an ability to present clear messages from complex information/data to all levels in the organisation.
-Demonstrated ability to prioritise and manage multiple tasks.
-Self-motivated and achievement driven.
-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.
-Strong computer skills - experience using various computer applications including spreadsheets, email, word-processing software.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group 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 46401 in all correspondence.