Clinical Trial Manager

My client, a global pharmaceutical company are now accepting candidates for the role of Clinical Trial Manager.

The Clinical Trial Manager will be a valued member of the Clinical Operations team in Dublin. He-she 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.

Key Responsibilities

• Manages global studies and/or regional components of global Phases II-III outsourced studies managed by a Clinical Program Manager.
• Independently manages 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 resolve 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.
• Coordinate’s review of data listings and preparation of interim/final Clinical Study Reports. 
• Contributes to development of RFPs and participates in 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.
• Travel is required.

Knowledge, Experience & Skills

• BSc or BA in a relevant scientific discipline or RN qualification.
• At least five years relevant clinical trial experience in the pharmaceutical industry.
• 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 interact with contacts cross-functionally at senior levels within the Company.
• Able to examine functional issues from an organisational perspective.
• Must be able to prioritise multiple tasks, plan proactively and accomplish goals using well defined instructions and procedures.

For full details contact Tina at tdunne@thornshaw.com or call +353 1 2784701/0876811990

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