The Manager of Clinical Operations is responsible for recruitment, growth, and development of Clinical Operations employees, which may include CRAs (Clinical Research Associates) or CTMs (Clinical Team Managers). They provide leadership in the implementation of PRA’s quality initiatives and business processes, achievement of its management goals and objectives within the framework of the company mission, policy and philosophy.
Manage and develop PRA employees to ensure high quality work performance and retention of high quality employees. Specific accountabilities may vary by area of expertise:
Responsible for the management of resources and resource projections to ensure project teams are consistent with client needs, expectations and contractual expectations by:
Provides leadership and implement Clinical Operations services and productivity improvements to ensure optimal utilization of billable staff by:
Be a point of escalation (internal) for resolution of issues and conflicts.
Evaluates compliance of assigned Clinical Operations employees with PRA systems and processes
Provides support with proposal development and participates in client presentations and/or bid defense meetings, as required
Mentors and trains other Clinical Operations management level employees
Displays expertise in the position by:
Assists more senior Clinical Operations staff in the review, development and implementation of short-term and
long- term objectives, major plans and programs for each functional group within Clinical Operations.
Creates and maintains effective relationships between other PRA business units or functions.
Participates in internal/external audits and regulatory agency inspections, as required
Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution, required.
Substantial experience using computerized information systems including experience with PC- Windows, word processing, and electronic spreadsheets, required.
Substantial clinical trials development experience is, required
Appropriate direct line management experience of Clinical operations staff; Experience supervising or
managing professional staff in a clinical research environment, required
Thorough knowledge of ICH and local regulatory authority regulations regarding drug research and development, required.
Read, write, and speak fluent English
Travel of up to 50% may be required for this position, if managing CRAs. Exact amounts of travel will vary, pending client needs.
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities.