Category: Scientific & Clinical
Title: Senior Clinical Study Manager
Location: Cambridge, MA
Type: Full Time, Salaried with benefits
Start Date: Immediate
Growing Pharmaceutical Company is looking to add a Senior Clinical Study Manager to their team! This role would lead and develop clinical operational activities in support of assigned clinical studies from start up through closeout.
- Organize, conduct and facilitate all operational activities of assigned clinical studies; design, planning and coordination of clinical trials, maintenance of study reporting systems, execution of tracking and creation of progress reports
- Organize and manage multiple activities related to clinical studies in various phases ensuring timeline milestones are met and in accordance to ICH-GCP and protocol requirements
- Collaborate with internal members of the clinical development group, consultants, contractors, CROs and sponsor representatives
- In conjunction with CRO, identify required study specific training of clinical staff, ensuring understanding of drug development process, and knowledge of international standards, and FDA/EMEA authorities
- Establish agreed upon clinical trial platform with CRO, develop effective electronic systems, and establishment of processes and plans
- Manage budgetary spend of clinical study, communicating with Head of Clinical Operations and Global Project Leader; negotiate clinical trial agreements and budgets, managing vendor site payments with relevant project team and legal teams
- Responsible for site identification and qualification, as well as site start-up, initiation and conduct of the study, guaranteeing timely recruitment of trial participants with secure randomization processes (if required) and closeout.
- Monitor trial progress, ensuring compliance with and adherence to the project plan, while identifying, assessing and resolving any problems.
- Ensure efficient and effective data collection and documentation, management and analysis upon study completion, followed up by final reporting
- Accountable for operations planning, feasibility, and execution of a clinical trial protocol
- Recognize and implement new methodologies that will positively impact clinical trial operations and costs
- Bachelor's Degree required, preferably in Life Sciences
- 3 years of clinical trial management experience in the Pharmaceutical/Biotech Industry or with a CRO, with 5 years of Clinical Operations experience
- Phases II and III studies in Oncology; hematology, immunology and/or neurological therapeutic areas
- Working in dynamic environments, with demonstrated ability to balance multiple priorities with high quality results
- Thorough knowledge of cross-functional clinical processes including data management, bio-statistics, medical writing, drug safety, and regulatory affairs
- Global study experience preferred
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.