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Project/Program Management Group

Manager, Clinical Programs EMEA

  • Título Manager, Clinical Programs EMEA
  • Função Project/Program Management Group
  • Sub função Project/Program Management
  • Local Aachen, North Rhine Westphalia, Germany
  • Postado
  • ID obrigatória 2406161254W
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Job Responsibilities:
The Manager, Clinical Programs EMEA reports to the Assoc. Dir, Clinical Affairs and Programs, EMEA and is responsible for the oversight, growth and development of our in-hause and remote Clinical Project Managers, Clinical Research Associates and Clinical Trial Coordinators. The Manager, Clinical Programs EMEA works in collaboration with the Medical Office EMEA and the US Clinical Programs team and is expected to manage EMEA clinical program activities including accelerating the planning, start-up, maintenance and closeout activities of Abiomed's clinical studies{IDEs, Post Marketing, lnvestigator lnitiated, etc.) through the development and execution of Clinical SOPs and processes in support of Clinical Programs. This person will train, manage, and develop Clinical Program personnel to ensure clinical trials are conducted in a controlled, compliant way, such that safety and privacy of subjects is ensured with the highest level of data quality and integrity.

Principle Duties and Responsibilities:

  • Responsible for hiring, training and retaining a diverse group of EMEA in-hause and remote Clinical Project Managers, Clinical Research Associates and Clinical Trial Coordinators, ensuring adherence to pertinent regulations through regular review of system metrics, Trial Master File review, communications with cross functional stakeholders and others as needed
  • Accountable for the development of direct reports through performance reviews, instruction, mentoring and coaching. This includes setting goals, conducting periodic and year end performance reviews, proactively identifying, and addressing any areas of concern, providing development opportunities to team members, and as needed, escalating performance and/or personnel issues
  • Hands on leadership to manage integration of all project team activities including clinical program management metrics, leveraging internal and development partner resources, expertise, and knowledge, along with optimizing CRO resources {when necessary), expertise and knowledge
  • Provide strategic input and execution of clinical trials with direct experience in EMEA from protocol design to the final clinical study report for specified studies and be responsible for leading project management activities for selected studies.
  • Effectively communicate and interact with Key Opinion Leaders
  • Manage strategic study operations including study sites and tracking systems for regulatory submissions, CRO KPls, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, performance metrics, data flow, etc.
  • Lead the development of contingency/risk management plans for projects and assist Director, Clinical Affairs and Programs in the preparation and execution of sound development strategies
  • Interface with Finance, Accounting, Quality, Regulatory, Medical Affairs EMEA and Medical Office (US), which may include leading subteams and/or acting as a liaison between groups
  • Maintains an understanding of current clinical regulations and common industry practices, engages in relevant professional associations or societies, and seeks continuing education
  • Participates in inspection readiness activities and audit activities performing Trial Master File (TMF) data management audits on a regular basis
  • Supports Director, Director, Clinical Affairs and Programs, Clinical Program Managers and Quality Assurance to ensure that all CAPAs are adequately developed, reviewed, and implemented
  • Facilitates collaborative environment through team building activities and leadership
  • Assist Director, Clinical Affairs and Programs, EMEA in preparation of Clinical Program study budgets and timelines for Worldwide Profit Planning (WWPP) projections for senior management for current and proposed studies. This will include the planning and development of budgets and strategies for first in human trial, investigator-initiated trials, randomized controlled trials, etc.


Job Qualifications:

  • BS degree in Science, Engineering, or related medical/scientific field; MS or graduate degree preferred
  • 8+ years of clinical research experience gained with a CRO or Medical Device Company working on later stage {Phase 2-4) multinational clinical studies involving Germany, UK, France, Netherlands and ltaly. Experience in Class III cardiovascular devices and/or difficult to recruit patient populations (i.e. urgent, emergency room consenting) required
  • 3+ years clinical project management experience with global clinical studies
  • Strang US and EU regulatory knowledge including experience with Ethics Committee and Competent Authority submissions in Germany, UK, Netherlands, ltaly and France, including Good Clinical Practices (GCPs)
  • Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning, and problem-solving ability.
  • Excellent German and English communication (written and verbal) and presentation skills along with leadership qualities.
  • Knowledge of global clinical trial management in fast paced environment. Ability to assemble a plan and execute on the details.
  • Experience with protocol, ICF, CRF, CSR development and review
  • Proficient with MS Office Suite (Excel, Word, and PowerPoint) and Project Planning Software (i.e. Wrike, MS Project, etc.)
  • Ability to be independent, multitask and results-oriented with a hands-on attitude in a fast-paced and energetic environment

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