Manage the execution of the assigned multi-regional study(ies), which may include study management, clinical and other functions per Contract, from initiation through to closeout. Ensure that all study management and project deliverables are completed to the Sponsor’s satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies and practices.
- Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles. Ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. Implement continuous improvement activities for assigned projects.
- Serve as primary project contact with Sponsor to ensure communication is maintained and continuously improved and reporting schedules are adhered to.
- Define, develop and implement study management plans, together with team assignments and accountabilities.
- Supervise team performance against contract, customer expectations, and project baselines. Develop recommendations for issue resolution for management and Sponsors.
- Supervise problem solving and resolution efforts to include management of risk, contingencies and issues. Take accountability for proactive contingency plans to mitigate clinical risk.
- Identify quality issues within the study through regular review of site communications, monitoring visit reports, data flow information and quality assurance audit findings and own the implementation of appropriate corrective action plans. Manage and oversee the escalation of findings and action plans to appropriate parties.
- Collaborate with other functional groups within the company to support milestone achievement and to manage study issues and obstacles. Ensure that Sponsor feedback is communicated and conveyed to other functional groups and action is initiated to address.
- Participate in proposal development, influence the scope and budget development of proposals for new work, including the study management costs. Escalate out of scope requests to management.
- Provide input to line managers of their project team members’ performance relative to project tasks. Recommend team members’ further professional development. Support staff development. Mentor less experienced CPMs.
- Prepare and present project information at internal and external meetings. Lead bid defense presentations in partnership with Business Development and Senior Clinical Project Management staff.
- Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA team.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
- In depth therapeutic and protocol knowledge
- Excellent communication and interpersonal skills, including good command of English language
- Excellent organizational and problem solving skills
- Track record of ability to work through others to deliver results to the appropriate quality and timeline metrics
- Good team leadership skills
- Effective mentoring and training skills
- Excellent customer service skills
- Good judgment
- Effective presentation skills
- Ability to manage competing priorities
- Demonstrated ability in project financial tracking and accounting methods and skill in applying them
- Good understanding of other Quintiles functions and their inter- relationship with Clinical Project Management
- Strong software and computer skills, including MS Office applications
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree in life sciences or related field and 10 years’ clinical research experience including 6 years’ project management experience and experience in clinical operations; or equivalent combination of education, training and experience.
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