Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking Associate Clinical Project Management (CPM)Directors/CPM Directors with Cardiovascular and Devices experience.
The Associate CPM Director/CPM Director will 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. 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.
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
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
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Quintiles Transnational has plenty to CRO about. One of the world's top contract research organizations (CROs), it...