Senior Clinical Trials Manager 12 M

A Senior Clinical Trials Manager I is required on An initial 12 Month basis by CareerWise Recruitment for our Dublin-based multinational pharmaceutical Company.

The Clinical Operations team in Dublin is a pivotal function of the Paediatric Centre of Excellence in Dublin and is responsible for the management and execution of Paediatric Clinical Trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures that all clinical trial activities are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high-quality clinical data to support global registration and commercialization of products.

The Senior 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.

THE ROLE:

• 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 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
• Demonstrates an ability to manage studies or programs of higher complexity from both a process and strategic perspective
• 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
• Excellent verbal, written and presentation skills are required
• Working knowledge and experience with Word, PowerPoint and Excel


Please call Aisling O’Hagan-Yil today for further information on 021- 2427410 or email: aohagan-yil@careerwise.ie

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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