·Provide operational leadership for assigned trials executing them on time and within budget
·Overall coordination and management of clinical trials from startup to closeout
·Liaise with other functional areas to identify issues, evaluate and make sound business decisions and ensure implementation of timely solutions.
·Identify and select high-quality clinical vendors in conjunction with the appropriate team members
·Work with the contracting/budgeting team to ensure that vendor responsibilities and payment terms are clearly defined.
·Manage and effectively provide oversight of assigned clinical vendors and functional service providers to ensure data integrity and adherence with regulatory requirements.
·Assure that team is receiving high quality, on time deliverables from internal and external vendors.
·Collaborate with other team members to coordinate the development and finalization of key study documents including protocols, case reports forms, informed consent documents, study management plans and final clinical study reports.
·Work with finance manager on financial aspects of the project(s), including milestone payments, and monthly pass through invoices
·Lead or facilitate teleconferences with internal or external group.
·Oversee Clinical Trial Coordinator for assigned project to ensure successful management of project(s), including development of the project plan, maintenance of trackers, and generation of metrics reports
·Assume co-monitoring responsibilities as needed.
·Communicate with Principle Investigator, Study Co-Coordinator, and/ CRO (if applicable) to proactively recognize problem situations and work with other team members as required to resolve issues
·Manage the publication process in conjunction with the publications team to assure that submission timelines are met.
·Monitor and report clinical trial status using standard and adhoc review & reporting procedures and identify issues that affect functions. Ensure that each function is accountable for their deliverables.
·In collaboration with Project Management and utilizing various tracking mechanisms, manage clinical trial project milestones and budget. Proactively identify issues and escalate to appropriate managers.