Sr. Clinical Trial Assistant or Associate Clinical Trial Manager
Greater Boston, MA
Job Summary
This person will be responsible for the successful planning, implementation and execution of contracted clinical monitoring activities. They will ensure clear client and internal team communication, process documentation, and coordination of relevant work.
Job Responsibilities
Drive the operational planning, content, execution, and delivery for one or more clinical trials.
Act as the main point of contact for assigned CRO and translational vendors to ensure GCP compliance and adherence to the scope of work while maintaining budgets and timelines. Responsible for trial related activities from startup to close-out of a clinical trial in close collaboration with internal stakeholders and CROs.
Support trial deliverables both in clinical and translational in a proactive and quality manner
Contribute to the development and implementation of study related documents such as protocol amendments, plans, and tracking tools.
Foster effective communication and collaboration with internal and external stakeholders, such as investigators, study sites contract research organizations (CROs), and vendors
Participate in process improvement and quality-related initiatives associated with study execution and deliverables; participate in establishment of best-in-class processes and standards for study conduct
Contribute to a collaborative culture within and outside Clinical Development and actively manage best practice sharing and capability building within the clinical team
Qualifications And Education Requirements
Bachelor's degree with minimum 3+ years of industry experience
Phase I oncology experience
Excellent project management skills, particularly, with managing CROs, consultants, and vendors in a team environment