Country Study Manager

My client is a first-class pharmaceutical company based in Dublin.  We are working with them on a new vacancy for a Medical Manager.  This is a fixed term contract.

Reporting to the Head of Medical Expertise, the Country Study Manager (CSM) has specific responsibilities for clinical trials in Ireland.

Purpose

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,  SOPs, local operating guidelines and local requirements, as applicable.

Key Tasks

• You will have full accountability and oversight for all assigned studies at regional/country level (Global and local studies) in accordance with the overall project plan, manages and maintains accurate country/study level plans (e.g. timelines, budget, resource, risk and quality plans) in the appropriate planning system.
• Highlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required.
• Leads local study teams, represents Country/Region Clinical Operations at the global SMT, and provides Global Teams with feedback from an Affiliate perspective (Global).
• Plans and executes country study goals and commitments, and ensures compliance to relevant processes.
• May serve as global Country Study Representative (gCSR), as part of global study team.
• Coaches and provides support to responsible study team members.
• Provides study oversight, leadership and support to Contract Research Organisation (CRO) staff to ensure overall delivery at the country and site level, and interfaces with CRO Management regarding feedback on CRO staff performance as required.
• Oversees study feasibility, site monitoring performance, preparation of Risk Based Monitoring plans, and ensures eTMF completeness and oversight of all relevant compliance activities for allocated studies.
• Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and completion of Corrective and Preventative Actions for allocated studies.
• Develops and maintains optimal site relationships with key investigator sites, alliance partners and/or collaborative group for current and future studies.
• Participates in overall Therapeutic Area support together with the therapeutic leads and country experts (e.g. landscaping activities, investigator/site development activities or affiliate cross functional teams, etc.), as required.
• Take personal responsibility for maintaining high ethical standards and operating in compliance with local and global  policies, the Group Code of Conduct, Quality Management System and the IPHA Code of Practice for the Pharmaceutical Industry.

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, SOPs/Guidelines and quality standards related to study management.
• Clinical development experience on the operational aspects of conducting clinical studies including:
• Vendor/CRO resource management
• Leading/working as part of a development team implementing clinical development plans
• Risk management
• 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

Closing date: 30th November 2020

For full details email Tina to tdunne@thornshaw.com or call +353 1 2784671

Thornshaw Scientific is a division of the CPL Group www.thornshaw.com