When you work for Quintiles you work for the world's leading Pharmaceutical Services Company. We offer product development and commercialisation services to the Pharmaceutical, Biotechnology and Medical Devices industries. Our leading-edge capabilities provide healthcare companies with the potential to bring new medicines/devices through development and registration to the market place more quickly, with supporting medical and drug data that will significantly advance the cost effectiveness and quality of healthcare provision. Of the world's top 30 best-selling drugs, Quintiles has helped to develop or commercialise every single one.
PURPOSE
We are recruiting for a Clinical Project Manager within our Late Phase Clinical Project Management Department to manage the execution of medium to large multi regionally-based clinical studies, from initiation through to closeout. This role is responsible for ensuring that all clinical 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.
RESPONSIBILITIES
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.
Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.
Serve as primary project contact with Sponsor to ensure communication is maintained and continuously improved and reporting schedules are adhered to.
Report on team performance against contract, customer expectations, and project baselines to management.
Lead problem solving and resolution efforts to include management of risk, contingencies and issues. Develop 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 to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.
Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
Provide input for the development of proposals for new work and project budgets.
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.
Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA team.
Prepare and present project information at internal and external meetings.
Participate in proposal development. May lead bid defense presentations in partnership with Business Development and Senior Clinical Project Management staff.
Define project workloads and assignments. Develop and oversee maintenance of internal databases and project plans
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
Strong communication and interpersonal skills, including good command of English language
Strong organizational and problem solving skills
Demonstrated ability 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
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 extensive clinical research experience including project management experience and experience in clinical operations; or equivalent combination of education, training and experience. Project Management experience within Late Phase
PHYSICAL REQUIREMENTS
Extensive use of keyboard requiring repetitive motion of fingers. Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Regular sitting for extended periods of time. May require occasional travel.
At Quintiles we value individuality, fresh ideas, and the contribution that our employees make to our success. In return we offer career opportunities providing flexibility and growth across the organisation, covering multiple locations to suite your lifestyle requirements at this time, a competitive salary and a fantastic benefits package.
If you want to make a difference in global healthcare, Quintiles is the place for you. It's work worth doing.
