Clinical Research Manager
- Full Time
Critical position for clinical department Work across development areas with Biosimilars and R&D groups Growing global business just 1 hour from Edinburgh Clinical Research Manager Provide effective study management and vendor oversight for assigned studies Clinical Study Management SOP development, support and training Clinical support to regulatory submissions Due Diligence activities Key Responsibilities: Protocol development Participate/presentation at Advisory Panel/Key Opinion Leader Meeting Vendor selection and oversight Preparation, review and managements of clinical contracts, in conjunction with legal Plan and agree regulatory and QA strategy for studies with respective departments Day to day management of CRO/SSP Essential documentation preparation Development and management of specific Clinical Study Plans Reporting study progress to key stakeholders Position Requirements Pharmaceutical or relevant Life Sciences degree Extensive Clinical Research experience Recent study management experience Has extensive recent knowledge of ICH GCP E6 R2 Significant depth of knowledge of all phases of development Proven successful ability to manage Clinical Research Organisations Has awareness of international legal requirements Flexibility to work across various time zones Global travel, approx. 20% Benefits Pension scheme Private medical insurance Other voluntary benefits include: Childcare Vouchers, Bike to Work This position is based in Galashiels within the beautiful Scottish Borders; only an hours commute from Edinburgh. About Kyowa Kirin International Kyowa Kirin International is going through an exceptional time. With rare disease product launches expected next year and further new product development combined with excellent international growth rates, we are providing a great platform for today and our future. Kyowa Kirin International plc is owned by Kyowa Hakko Kirin Co., Ltd (KHK) of Japan. Founded in 1949, KHK has a successful track record in Japan and is now expanding globally. Our highly successful product portfolio, enviable pipeline and active Business Development group provides a wealth of products in the therapeutic areas of Oncology, CNS and Nephrology. With three key anti-body therapies in late stage development Kyowa Kirin is setting the scene for transformative growth. Kyowa Kirin International is an equal opportunities employer.