System One Services Clinical Study Manager in Cambridge, Massachusetts
Clinical Study ManagerCambridge , Massachusetts
Category:Scientific & Clinical
Title:Clinical Study Manager
Type:Full Time, Salaried with benefits
Growing Pharmaceutical Company is looking to add a Clinical Study Manager to their team!
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.