Job Description
Thornshaw Scientific, on behalf of our client, a Global Pharmaceutical Company now have a new vacancy for a Clinical Project Lead.Working with the Global Clinical Operations Director you will drive the clinical operational process management, quality assessment, SOP, process review and implementation.Key Responsibilities:·Providing operative input during the preparation of the clinical trial synopsis (expected timeline, feasibility, costs)·Providing support in finding, pre-screening, contacting, coordination of in-house selection of external partners (clinical research organization – CRO)·Evaluating and coordinating the in-house evaluation of CRO proposals, supporting contracting, following project status according to the agreed timelines/milestones and verifying the invoices accordingly·Supporting additional agreements (e.g. agreements about investigational medicinal product (IMP) handling, site/investigator agreements), working together with the clinical drug supply manager·Point of contact internally and externally (CROs), facilitating communication among the stakeholders·General project management duties in the given clinical trial (timeline, costs, and quality) according to the commercial and regulatory needs of the company·Coordination of the clinical study protocol preparation (based on the provided synopsis) with the involvement of internal experts and external vendor(s) as needed, review.·Compilation of medical documentation needed for the clinical trial application (CTA) (involving other experts if needed), coordinating the compilation of other documents (e.g. IMP related documentation, insurance, SDEA, Quality Agreement)Qualifications & Experience:·Life Science/Medical or pharmacist qualification and experience in clinical operational activities including the relevant therapeutic areas (Women’s and men’s health care) (latter optional)·2-5 years of experience in pharmaceutical clinical role managing clinical trials and providing oversight on vendor activities·Ability to translate complex medical information and data into a succinct, technically correct, readable documents.·Experience with GCP and related quality compliance·Flexibility in working in multiple therapeutic areas as need arises.THE PERSON?·Are you a Results and performance driven individual? ·Do you have a Positive and pro-active approach with quality and GCP focus?·Can you lead and support several concurrent projects/products and develop strong relationship within cross-functional teams? Fantastic opportunity to grow and develop within this organisation. For full job spec and information please send your CV to tdunne@thornshaw.com or call Tina at +353 1 2784701 / 087 6811990.Thornshaw Scientific is a division of the CPL Group of companies. www.thornshaw.com#LI-TD1 #J-18808-Ljbffr