Here, in Hays Life Sciences, our Multinational Clinical Trials client in Dublin is hiring a Clinical Trails Manager.

The Clinical Trials Manager will be a valued member of the Clinical Operations team. They will work with the Clinical Program Manager and study teams 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.

Key Responsibilities:

• Manages global studies and/or regional components of global Phases II-III outsourced studies
Managed by a Clinical Program Manager.

• Independently manage all components of a small, less complex clinical study.

• Manages cross-functional timelines and maintains the study timelines.

• Contributes to the development of the study budget.

• Manages vendors, including CROs.

• Will serve as the primary point of contact for CROs, addressing questions and applying knowledge

To solve problems.

• Assists in determining the activities to support a project’s priorities within a functional area.

• Drafts and coordinates review of relevant documents including protocols, Informed Consents, Case

Report Forms, monitoring plans, Investigator Brochures and Clinical Study Reports.

• 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.

• Contributes to the development of RFPs and participates in the selection of CROs/vendors.

• 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.

• May be asked to train 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 the development of abstracts, presentations and manuscripts.

• Supports the professional development and mentoring of Clinical Trial Manager Associates.

• May conduct oversight monitoring visits, as required.

• Travel is required.

Education and/or Experience:

• B.Sc. or BA in a relevant scientific discipline or RN qualification.

• At least 8 years of relevant clinical trial experience in the pharmaceutical industry.

• Demonstrates an ability to manage studies or programs of higher complexity from both processes

and strategic perspective.