Description
We are seeking a Project Manager I to join our Clinical Solutions team in Shanghai. As a Project Manager I, you will be responsible for managing a project, overseeing interdisciplinary clinical research studies, and ensuring compliance with GCP, relevant SOPs, and regulatory requirements.
Job Responsibilities
- Manage a project as a project manager, overseeing interdisciplinary clinical research studies and ensuring compliance with GCP, relevant SOPs, and regulatory requirements.
- Act 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.
- Be 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 SOPs, and regulatory requirements, and be 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, and oversight for development and implementation of project plans.
- Plan, coordinate, and present at internal and external meetings, and prepare project management reports for clients and management.
- Develop contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
- Develop 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%).