What are the responsibilities and job description for the Clinical Project Manager position at Actalent?
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Description:
- Independently oversee clinical studies from concept to close-out
- Responsible for managing all study activities for a Phase I study
- Managing study timelines, study budgets, and CROs and other external vendors
- Facilitate meetings internally/externally with with key cross-functional teams
- Independently manage and oversee study activities, including: selection of investigators, study start-up activities including site initiation, study monitoring activities, data collection and close-out activities
- Provide input to both the CRO and internal clinical development plans for the study, and ensure study team adherence to the plans as needed and appropriate per study needs
- Develop and manage study timelines and project and track study enrollment
- Contribute to the development of study related documents (contracts, ICF(s), protocol(s), IB(s), etc.)
- Prepare clinical study budgets, monitor budgets for variances and approve invoices, as needed
- Address and escalate relevant operational issues to key stakeholders
- Be aware of and be able to predict deviations, or potential non-compliance concerns (at a protocol level, site level, study level) and rapidly resolve or escalate appropriately
Additional Skills & Qualifications:
- Bachelor’s degree or equivalent curriculum (scientific or healthcare discipline preferred)
- 3 years of PM experience with direct clinical trial management, including management of vendors and CROs and ex-US trial experience is a plus
- Prior experience independently managing phase I clinical studies
- Experience in early-stage clinical development is strongly preferred
- Experience with Microsoft Project is a plus
- Working knowledge of GCP, ICH and relevant CFRs is required
- Project management skills, effective communication (written and verbal), adaptability and self-motivation are required attributes
- Strong time management skills; ability to prioritize multiple tasks efficiently
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
