Clinical Project Manager
- Experience Level
- Experienced (non-manager)
Linical Co., Ltd. (‘Linical’) is a premier global CRO headquartered in Osaka, Japan, listed in the prime segment of the Tokyo Stock exchange, and dedicated to serve its clients as a true partner in development. With more than 800 employees, Linical directly covers a total of more than 20 countries in Europe, North America and Asia-Pacific including Japan via its own offices and staff.
Linical’s European arm is headquartered in Frankfurt, Germany with a substantial presence in Paris and Madrid. Its geographic footprint facilitates a significant presence in the leading Western European markets, combined with well-established affiliate operations in key emerging markets in Central- and Eastern Europe.
We offer individualized solutions that are tailored to the specific needs of our sponsors. We work as integrated international teams functioning with maximum transparency throughout each study, making sure that the sponsor is kept up to date on all study parameters and progress. We are dedicated to the highest standards of quality, with a special focus on the therapeutic areas immunology, oncology and CNS, based on experience and expertise.
- University/college degree in a life science field (Master’s or other advanced degree is preferred) or equivalent experience/ education with at least 5 years of clinical research experience in a CRO, biopharmaceutical company or relevant clinical environment
- 2 to 3 years of experience managing phase I to III projects from start to finish; late phase/ post-marketing studies experience would be a plus
- Outstanding written and oral English skills
- Expertise in managing, leading and motivating teams across multiple functional areas and regions
- Strong interpersonal, communications, presentation and negotiation skills
- Good customer management skills, including ability to lead and facilitate at customer meetings
Main Duties and Responsibilities:
Linical is seeking an experienced Project Manager to support the project team in the delivery of quality clinical trial management services to achieve the successful overall project completion. This position offers you the opportunity to lead full-service international to global clinical research projects.
The location of this position could be in any of the countries in which we are operating (e.g., Poland, Hungary, Germany, France, Spain, UK).
- Provide leadership and guidance to the project team, vendors and customer to ensure successful execution of all work conducted in the clinical project group and to ensure timely delivery of high-quality deliverables
- Work collaboratively with the assigned Medical Project Leader to ensure that all relevant scientific and clinical issues are addressed in planning and execution as well as to obtain appropriate medical input and assistance to resolve any project issues
- Plan, organize and manage all aspects of assigned clinical trial projects together with all functional departments and vendors involved in the project
- Maintain current knowledge of SOP’s and regulatory guidance documents which impact the project group
- Act as a bridge between operations, business development and other global support groups and assures the integration of all functions to ensure client satisfaction
- Assure a high-level analysis of project status as it relates to milestones and customer expectations and ensures project management tools are available and used to track, forecast, report and measure project progress
- Work closely with finance and legal to manage all financial and contractual aspects of the study, e.g. management of overall project budget and payment status