Project Manager II, Early Development – FSP Model
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Job Description
Project Manager overseeing interdisciplinary clinical research studies at a leading life sciences services organization. Ensure compliance, manage budget, and develop strong client relationships.
Responsibilities:
- 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
Requirements:
- 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 + experience in Early Phases
- 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%)
Benefits:
- We are passionate about developing our people, through career development and progression
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition and total rewards program
- We are committed to building an inclusive culture – where you can authentically be yourself
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