Project Manager - Future Roles (UK)
Job Responsibilities
* Project Leadership and Delivery. Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements.
* Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement.
* Lead project team to ensure quality, timelines and budget management.
* Accountable for the financial performance of each project. Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
* Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements. Accountable for all project deliverables for each project assigned.
* Responsible for quality and completeness of TMF for assigned projects.
* Accountable for maintenance of study information on a variety of databases and systems.
* Responsible for study management components of inspection readiness for all aspects of the study conduct. Oversight for development and implementation of project plans.
* Plan, coordinate and present at internal and external meetings. Prepare project management reports for clients and management.
* Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
* Develops strong relationships with current clients to generate new and/or add-on business for the future.
* May participate in bid defense meetings where presented as potential project manager.
* May be required to line manage other project management team members and clinical monitoring staff.
Qualifications
* Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience.
* Clinical research organization (CRO) and relevant therapeutic experience preferred. Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
* Strong organizational skills.
* Strong ability to manage time and work independently.
* Direct therapeutic area expertise.
* Ability to embrace new technologies.
* Excellent communication, presentation, interpersonal skills, both written and spoken.
* Ability to travel as necessary (approximately 25%).
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