Cache of job #13911021

Job Title

Clinical Affairs Manager

Employer

ICDS Recruitment

Location

Waterford

Description

Clinical Affairs Manager - County Waterford. Job Purpose: To support the Head of Scientific Affairs with clinical activities associated with the registration of the company's products in worldwide markets including US, EU and ROW. Support activities for running Clinical Trials (efficacy and PK) and Bioequivalence Studies. To ensure that project plans and milestones are delivered according to agreed timelines. Key Responsibilities: 1. Project Planning/Co-ordination. - Together with the Head of Scientific Affairs, Relevant Programme Managers and the Clinical Manager, actively plan the Clinical function requirements ensuring major milestone targets for each product are visible to all team members and key stakeholders to achieve on time market entry. - Together with the Head of Scientific Affairs and relevant Project Programme Manager, determine tasks and resources required to deliver each project milestone and deliverable. 2. Clinical Studies. - Responsible for Design and management of all PK/ Bioequivalence studies. - Support efficacy studies. - Act as company representative when liaising with clinical experts for such clinical studies. 3. Dossier preparation. - Manage the preparation of relevant dossier sections in collaboration with the Regulatory Affairs Manager to support license applications including clinical and non-clinical overviews. 4. Leadership. - Coaching/mentoring - support members of team with problem solving and skills development to aid learning and early problem resolution. - Manage applicable clinical affairs budget and cost centre activities required for delivery of clinical milestones. Minimum Qualifications & Experience required: Minimum B.Sc. ideally in Pharmacy or Pharmacology, however MB in Medicine is desirable. At least 10 years' experience in Clinical affairs. Familiarity with cGCP and cGMP in pharmaceutical manufacturing. Familiarity and experience with EU and US Clinical trials legislation. Ability to understand complex clinical terminology and aptitude to learn new skills in the area of clinical research though working with external experts and CRO's. Good negotiating skills. This job originally appeared on RecruitIreland.com.

Date Added

2107 days ago

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