$80K - $100K(Ladders Estimates)
Plans, manages and coordinates the execution of clinical study/studies according to regulatory requirements and Vanguard Standard Operating Procedures for all site(s), nationwide. Provides updates and ensures coordination between cross functional study team(s) to meet study objectives, on time and within budget.
1. Participates in cross functional study team(s) in protocol development, process development, data management amendments and administrative changes.
2. Contributes to protocol synopsis development including Clinical Operations feasibility assessments.
3. Prepares accurate and timely reports/data, participates in creation and maintenance of business development activities and SOPs, supports during audits.
4. Mentors and trains Site Managers on operational delivery for all clinical projects project tracking and reporting. May serve as liaisons with specific Sponsors.
5. Manages strategic partners, vendors, consultants for assigned studies.
6. Performs the evaluation and selection of vendors, including contract and budget negotiations. Responsible for the day-to-day management of vendors, ensuring assignments, timeframes and budgets are met.
7. Assists with site identification and selection, enrollment models, clinical supply planning and drug supply, organization of investigator and vendor meetings, development of informed consents forms, planning and management of Trial Master File, development of monitoring plans and Electronic Data Collection (EDC)/ Case Report forms and writing the Clinical Study Report.
8. Collaborates with Study Execution Team to identify study risks, develop risk mitigation plans, including communication and collaboration with program management, and escalates risks and study issues, with proposed solutions, to management as necessary.
9. Escalates medical issues to appropriate medical personnel, as needed.
10. Performs related duties, as required.
*ADA Essential Functions
Valid Through: 2019-10-28