The Lead Project Manager assists the Director with the day-to-day operations and provides leadership, training and support to the clinical staff to ensure high quality, monitor workload volume and efficient productivity. They maintain effective and positive working relationships with patients, sponsors, physicians, and employees.
Responsibilities may include but are not limited to:
- Train new and current Project Managers and Research Assistants to ensure effective coordination of training activities in the clinical trials processes
- Assist Project Managers and Research Assistants with assigned tasks as necessary
- Ensure pre-screens convert to screens and screens convert to randomizations
- Monitor team’s workload, schedule/calendar, and capacity
- Provide clinical support and assistance in the assignment of PM’s, Raters, and other staff
- Troubleshoot and resolve clinic, protocol, and SOP issues and advise PM’s
- Assist coordinators with assigned tasks as necessary
- Problem solve protocol issues with staff as necessary
- Work closely with the Director to improve and streamline clinic processes
- Work with Director, Recruitment, and other clinical team managers as necessary to find ways to increase visits across the team – goal of 15 points per week per PM
- Liaison between team and other departments to ensure smooth, effective, and quality work flow
- Assist the Director with projects and tasks as assigned
- Fill in as needed in the absence of PM’s
- Acting Supervisor or point of contact in the absence of the Director
- Provide assistance with study protocol adherence as necessary Secondary Responsibilities
- Maintains Quality Service and Departmental Standards by Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)
- Assisting in establishing and enforcing departmental standards Contributes to team effort by
- Working with internal staff to resolve issues
- Provide assistance with study protocol adherence as necessary
- Exploring new opportunities to add value to organization and departmental processes
- Help ensure prescreens convert to screens and screens convert to rands
- Helping others to achieve results
- Performing other duties as assigned
- Support the organization’s mission and goals Maintains Technical and Industry Knowledge by
- Attending and participating in applicable company-sponsored training
- Assist with team staffing plans, interviews, and performance evaluations
- Help reassign visits when need arises i.e. sick and vacation days
- Facilitate rapid study startup so that screening of new subjects into new trials begin ASAP
- Assist with and attend SIVs as needed
- Assist with PSVs and clinic tours as needed
- Bachelor’s degree in a health-related field, or Master’s degree with a minimum of 2 years of Clinical Research Coordinator experience.
- At least 4 years’ experience in clinical research or a relevant clinical role.
- Strong working knowledge of GCP and FDA requirements.
- Knowledge of medical terminology and clinical practices.
- BLS Healthcare Provider required.
- Applicants that don’t meet 100% of the above qualifications but who have a combination of related education and applicable experience may be considered upon approval.
We offer a flexible schedule, competitive salary, benefits, bonuses, and advancement opportunities.
This position is located in Maitland.