Pharmaceutical & Biotechnology

Clinical Trials Manager

  • Contract
  • Dublin City Centre, County Dublin, Ireland
  • 42035829

The Role

PE Global are recruiting for a Clinical Trials Manager for our pharmaceutical client based in Dublin CC. This is a 12-month contract role. Onsite role.

Job Responsibilities

  • Independently manages all components of a small less complex clinical study.
  • In partnership with CPMs, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines.
  • Responsible for management of the clinical trials budget.
  • Experience in developing RFPs and selection and management of CROs/vendors.
  • Will serve as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems.
  • Assists in determining the activities to support a project’s priorities within a functional area.
  • Ability to write study protocols, study reports, sections for Investigator Brochures and regulatory documents with little supervision. Drafts and coordinates review of relevant documents.
  • Must be able to understand, interpret and explain protocol requirements to others.
  • Coordinates review of data listings and preparation of interim/final Clinical Study Reports.
  • In collaboration with data management, develops and participates in review of clinical study data and other metrics to ensure data integrity.
  • Responsible for filing necessary documents in the electronic trial master file (TMF), and provide oversight for regular cross-functional reviews of the TMF.
  • Provides guidance and training to CROs, vendors, investigators and study coordinators on study requirements.
  • May serve as a resource for others within the company for clinical trials management expertise.
  • Participate in departmental or interdepartmental strategic initiatives under limited supervision.
  • May contribute to development of abstracts, presentations and manuscripts.
  • Line management of individuals with oversight from the CPM. Coaches and supports the professional development of a work team.
  • May conduct oversight monitoring visits, as required.

 

Education & Experience

  • BSc or BA in a relevant scientific discipline or RN qualification.
  • At least six years relevant clinical trial experience in the pharmaceutical industry.
  • Resourcing Excellence
  • Demonstrates an ability to manage studies or programs of higher complexity from both a process and strategic perspective.
  • Ability to work independently with minimal oversight, identify issues and adapt to changes.
  • Demonstrates an ability to influence contacts cross-functionally at senior levels within the Company.
  • Able to examine functional issues from a broader organisational perspective.
  • Must be able to prioritise multiple tasks, plan proactively and accomplish goals using well defined instructions and procedures.
  • Must be able to anticipate obstacles, develop and implement solutions to achieve project goals.
  • Must have a general understanding of functional issues and routine project goals from an organisational perspective.
  • Must have a general, functional expertise to initiate, author or contribute to SOP development and implementation.
  • Excellent interpersonal skills and demonstrated ability to lead is required.
  • Strong communication, decision-making and influencing skills and ability to create a clear sense of direction is necessary.
  • Knowledge of FDA and/or EMEA Regulations, ICH Guidelines and GCP governing the conduct of clinical trials.
  • Excellent verbal, written and presentation skills are required.
  • Working knowledge and experience with Word, PowerPoint and Excel.

 

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up-to-date CV aisling.oleary@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****