What will you be doing?
- The Manager of Clinical Operations is responsible for recruitment, growth, and development of Clinical Operations employees. 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 accountabilites 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:
- Develops plans to support growth and career development of assigned Clinical Operations employees as well as manage the delivery of quality performance in line with their job description.
- Ensures staff development and performance feedback are provided through activities such as mentorship and career development
- Communicates team and individual goals and expectations to ensure direct reports understand their responsibilities
- Responsible for managing the performance of staff, including providing input into salaries, bonuses as well as nominations for promotion.
- Promotes a positive and professional work environment that attracts and retains the best talent and delivers services that exceed customer expectations.
- May conduct assessment visits with staff as required by SOPs
Provides leadership and implement Clinical Operations services and productivity improvements to ensure optimal utilization of billable staff by:
- Reviewing project tasks and timelines and assigning team members
- Determines level and type of employee resources to meet corporate/client/project objectives
- Schedules and reviews project tasks, provides leadership in the delivery of services to clients
- Provides guidance/insight on aspects of clinical operations, as well as contingency planning, to accommodate projects while identifying potential impacts to the budget
- Leading Clinical Operations employees in the delivery of services to clients
- Ensuring staff fulfill their responsibilities in accordance with PRA’s policies, procedures, SOPs, ICH-GCPs, and other relevant regulatory requirements
- Liaising with other functional managers to ensure consistency within the company
- Maintaining utilization of all Clinical Operations employees within department goals
Be a point of escalation (internal) for resolution of issues and conflicts.Evaluates compliance of assigned Clinical Operations employees with PRA systems and processesProvides support with proposal development and participates in client presentations and/or bid defense meetings, as required
- Performing metric collection and data analysis to support PRA’s continuous improvement in policies, procedures, and business process
- Identifying and implementing process improvements through review of clinical operations SOPs, processes; recommending improvement plans to senior management.
- Leading task forces to implement process improvement initiatives
- Building teamwork and improving process and productivity by working within and across functional areas
What do you need to have?
- Substantial experience using computerized information systems including experience with PC- Windows, word processing, and electronic spreadsheets preferred
- Substantial clinical trials development experience is preferred
- Experience supervising or managing professional staff in a clinical research environment preferred
- Thorough knowledge of ICH and local regulatory authority regulations regarding drug research and development is preferred
- Read, write, and speak fluent English; fluent in host country language preferred.
- Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution preferred.
- Advanced degree, or its international equivalent, preferred.
- 3-5 years direct line management within CRO environment, preferred.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.