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Job Ref.: 1837

Job Title: Clinical Study Manager – Pharma - Contract – Dublin based – January 2020

Posted Date: 19/01/2020

Sector: Clinical Trials

Location: Ireland, Dublin

Job Type: Temporary / Contract

Job description:

Career Opportunities - 2020

Clinical Study Manager – Pharma - Contract – Dublin based – January 2020

Our client, a major pharmaceutical company wish to recruit a Clinical Study Manager to join their team.

The position is for a fixed term contract of 11 months.

The Clinical Study Manager (CSM) works within the Medical Expertise Skill Centre and has specific responsibilities for clinical trials in Ireland.  They provide 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.  They may also support the wider team in other aligned activities

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.

Manages overall operation of the entire clinical study including project planning, budget, resource management and contract research organization management. Manages clinical operational plan, and incorporates the study and scientific plan. May develop study related documents and overall direction for the clinical sites to establish protocol development. Uses statistical analysis systems, such as SAS, as appropriate. Ensures compliance with good clinical practices, good manufacturing practices and regulatory guidelines. Recommends and implements innovative process ideas to impact clinical trials management. May develop and manage clinical budget and develop contingency plans for clinical trials. Oversees clinical trials staff and manages all aspects of clinical operational plan. Responsible for managing full scope of study, protocol and scientific publications. Acts as a cross functional liaison to ensure study plan aligns with business development strategies. Selects, develops and evaluates employees to ensure the efficient operation of the function.

Key Tasks

  • Has 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 company 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 clinical 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 company policies, the company 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, Company 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


  • Inspiring & Influencing

  • Communication

  • Achieving Results

  • Feedback & Coaching

  • Technical & Business Expertise

An excellent salary plus strong benefits package will apply to the position.

For further information, please call Paul Flanagan at Dublin +353 1 805 5522 or e mail your c/v in the strictest confidence to us asap







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