Process Specialist

Details of the offer

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. 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 to ******

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

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Nominal Salary: To be agreed

Job Function:

Requirements

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