Senior Clinical Project Manager - Real World & Late Phase - St Prex - Switzerland

This is your chance to join the fastest growing business unit within Quintiles;

Real-World & Late Phase Research

Within Quintiles, the Real-World & Late Phase Research (RWLPR) business unit employs over 1,000 dedicated staff to design, implement and manage real-world and post-marketing studies. As healthcare stakeholders increasingly need evidence to support regulatory, reimbursement and prescribing decisions, the Quintiles RWLPR team offers a comprehensive evidence approach to meet our customer’s unique needs for demonstrating safety, effectiveness and quality.

We are looking for an experienced Clinical Project Manager to manage the execution of assigned medium to large multi regionally-based clinical study(ies) per Contract, from initiation through to closeout. You will guarantee 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.

As a Clinical Project Manager, it will be your responsibility to;

  • 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, and may lead bid defence 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.

Please note, this role can be home of office-based, and occasional travel should be expected (20%).

Our ideal candidate will have a degree in Life Science or related field, with considerable clinical research/operations experience inc. project management specifically; or equivalent combination of education, training and experience. Knowledge of Late Phase Research; observational, non-interventional studies or large population studies would be a distinct advantage.

We will also be looking for;

  • 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 – which is essential
  • Strong organizational and problem solving skills
  • Demonstrated ability to deliver results to the appropriate quality and timeline metrics
  • Effective team leadership, 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 co-workers, managers and clients.

Quintiles is the world’s largest provider of biopharmaceutical development and commercial outsourcing services. We bring a fully integrated approach to build biopharma and life sciences solutions – from pipeline through portfolio to population health™. A career with Quintiles connects you to great opportunity to achieve professional success and impact healthcare around the world.

To find out more about this exciting new business unit, please visit; http://www.quintiles.com/services/real-world-and-late-phase-strategy

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