Clinical Trial Project Manager
1 week ago
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The Clinical Trial Project Manager plays a pivotal role in the development of relevant concepts, techniques, and processes by assisting and leading the study team across all investigator sites. With experience, this professional assumes responsibility for more complex tasks and applies creative and effective solutions where needed.
This individual works on assignments requiring judgment and initiative with an understanding of the implications of the work being performed. They independently identify tasks/issues that need to be addressed while being highly organized with the ability to multitask and adjust direction based on changing project/corporate priorities.
In this local-to-Norwood-MA position (onsite 3 days/week, remote 2 days/week), you will ensure compliance with protocol and overall objectives across all investigator sites. You will perform project/study management-related responsibilities from inception through database lock by coordinating and tracking activities for protocol and SOP compliance as well as regulatory guidelines.
You will work closely with all functional areas as well as external providers to ensure consistent, high-quality study outcomes. Your primary responsibilities include executing study activities according to study protocol, regulatory guidelines, and operational plans. This includes reviewing Investigational Drug Brochures (IDBs), protocols, Case Report Forms (CRFs), and Informed Consent Forms (ICFs) for a thorough understanding of study drug and procedures.
You will keep abreast of SOPs, Good Clinical Practice (GCP), and ICH guidelines as well as state and federal laws and ethical standards. Participation in study start-up, conduct, and closeout activities is also expected. Additionally, you will assist in preparation of vendor requests for proposals and track receipt of proposals, MSAs, and SOWs.
Key Qualifications:
- Bachelor's degree in health sciences or related field required
- Minimum 3-5 years relevant experience
- Excellent written and verbal communication skills
- Strong PC skills (MS Word, MS Excel, MS Project)
- Sound analytical and problem-solving skills
- Act with consistent sense of urgency with acute attention to detail
- Working knowledge and experience with Electronic Data Capture (EDC) systems and CTMS preferred.
- Exceptional organizational and time management skills
Estimated Salary: $90,000 - $110,000 per year
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