Director, Clinical Management

Clinical Operations Paris, France


Description

Position at Premier Research Group Limited

Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research.

We’re looking for a talented and energetic Director, Clinical Management to join our team in our Paris Office in France - this role is to be office based in Paris, France. This is a permanent opportunity.

Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.

Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!

The position will hold the overall responsibility for the leadership and management for Clinical Management function in Europe. The role will also be responsible for providing senior Leadership in France.

You'll be accountable for: 
  • Managing Clinical Management employee resources and employee resource projections to ensure that project teams meet client expectations and contractual obligations
  • Leading staff of a particular region, often with multiple staff reporting into them
  • Interfacing with other departments to design cross-functional process efficiencies or develops new approaches to the clinical management and monitoring of clinical trials considering Phase I - IV paradigms
  • Ensuring audit preparedness of Clinical Management employees, including training records, processes, and SOP compliance
  • Participating in budget activities, optimizing profitability of the department
  • Reviewing RFP’s, assesses monitoring strategies and resources to support budget development
  • Participating in Business Development presentations as appropriate
  • Providing direction to the line management on operational delivery for all clinical projects. May serve as a liaison with specific Sponsors on key programs and initiatives
  • Participating in the development of long and short term objectives for the department
  • Overseeing staff utilization and productivity
  • Serving as liaison with Clinical Operations colleagues globally to ensure continuity throughout
  • Participating in the recruitment, retention and ongoing professional development of Clinical Management employees
  • Directing the development and management of departmental performance metrics, training and training standards for the regions assigned
  • May be accountable for a library of information for Clinical Management
  • Ensuring and delivers appropriate transition planning and stakeholder communication for any handovers or change in staffing
  • Must be available to perform up to 25% of overnight travel, as required (additional travel is possible based on project and role requirements)
  • Local office leadership, oversight, signatory, and regulatory responsibilities
  • Acting as escalation point of contact for local issues in conjunction with local senior management & HR
  • CT submission documents review and signature as required
  • Local HR & Recruitment support as required
  • Local Vendor Management (+/- signatory rights) when required
  • Active role in local Business Continuity and Development activities - including attending local network events and conferences
You'll need this to be considered:
  • Recognized undergraduate degree is required. A degree in Pharmacy, Biology, Chemistry, Psychology, Nursing or a related discipline is preferred
  • Extensive clinical research experience is required (10 years +)
  • Minimum 5 years supervisory / management experience including oversight of larger groups - preference for prior experience managing Clinical Managers
  • Proven people manager able to guide staff through major changes, encouraging teamwork and developing team capabilities
  • Ability to drive projects to a successful completion both as a project leader and within a leadership role
  • Strong networks in France
  • Prior experience working in a country leadership role would be preferred
  • Knowledge of ICH / GCP regulations
  • Working knowledge of local country regulations (e.g, FDA and EMA Guidance Documents /NA Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures)
  • Fluent verbal and written English as well as the local language(s) 
  • Strong verbal and written communication and negotiation skills - able to communicate at all levels 
  • Maintains a positive, results orientated work environment
You must be eligible to live and work in France in order to apply for this role