Title: Senior Clinical Trial Manager Location: Dublin (onsite) Contract Type: 12 month Contract Pay Rate: €35 - €40 per hour Summary: Our leading Pharmaceutical client is looking to hire a Senior Clinical Trials Manager in their Dublin site.
The Clinical Operations of this role will support the function of the Paediatric Centre of Excellence onsite.
The Senior Clinical Trial Manager will work with the Clinical Program Manager to manage global clinical trials or regional components of global clinical trials and/or the entire process of a local clinical trial, with the ability to identify issues and adapt to changes.
Responsibilities Independently manages global studies and/or regional components of global Phases II-III outsourced studies.
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.
Travel is required.
Requirements: 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.
Knowledge of FDA and/or EMEA Regulations, ICH Guidelines and GCP governing the conduct of clinical trials.
Working knowledge and experience with Word, PowerPoint and Excel.
KSGalway __PRESENT__PRESENT Gi Group Holdings Recruitment Limited group of companies includes Gi Recruitment Limited, Draefern Limited, Gi Group Recruitment Ltd, INTOO (UK) Limited, Marks Sattin (UK) Limited, TACK TMI UK Limited, Grafton Professional Staffing Limited, Encore Personnel Services, Gi Group Recruitment Ireland Limited and Kelly Services (UK) Ltd. Gi Group Recruitment Ireland Ltd are acting as an Employment Business in relation to this role.
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Skills: Pharmaceuticals Clinical Trials Management