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Details

Clinical Development Senior Manager


Reference:SCAWOH-462701 Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Clinical Development Senior Manager
Our client, a global Pharmaceutical organisation are currently recruiting for a Clinical Trial Development Senior Manager to join their team on a permanent basis. As Clinical Development Senior Manager you will provide leadership, direction, and technical expertise to the study managers, leads the clinical teams responsible for the execution and delivery of the clinical package and support the execution of the integrated clinical development plans.

Responsibilities

  • Recruit, develop, and retain a diverse and highly capable workforce
  • Ensure robust individual training plans and timely completion of required training for direct reports
  • Support and enable talent identification and career development that reflects an end-to-end mindset and demonstrates judgement-based decision making
  • Ensure study manager competencies are present and continuously improving
  • Manage study manager workload based on portfolio prioritization, regional requirements, and individual level of expertise, and address implications to overall resource management and strategies
  • Support and encourages a culture of innovation and the learning that comes from new/novel approaches to clinical development and models inclusivity to ensure diverse voices and ideas are heard and considered
  • Support clinical development from strategy and profile development through submission, inspection, approval and post-launch support
  • Manage program-level activities including management of risk plans and oversight of budget planning, monitoring, and control
  • Work closely with the Clinical Trial Project Managers to ensure efficient and on-time execution of trials and enables aggregation / roll-up of key trial metrics to track the status of the portfolio
  • Ensure effective transition of the complete clinical trial package (scope, timeline, budget and risk management) through trial execution and clinical delivery
  • Manage global cross-functional communication and issue escalations to ensure alignment on delivery and execution
  • Utilize regulatory and process knowledge to drive decision-making
  • Establishes and manages expectations of external partner relationships, performance and delivery Effective Management
  • Ensure a compliance culture and state of inspection readiness of TMF records created


Requirements

  • Bachelors Degree, preferably in a scientific or health-related field
  • Previous experience, at least 5 years in a lead role in the pharmaceutical industry and/or clinical development
  • Must understand clinical development processes and the interdependencies of various tasks that require coordination among cross-functional team members and third parties
  • Demonstrated core project management skills through management of complex/cross-functional projects, and/or clinical trials with a strong knowledge of regulations and guidelines
  • Strong communication skills; able to communicate clearly and succinctly with team members and leadership
  • Must be capable of managing staff virtually and across geographies/cultures
  • Proven ability to coach and develop others

Other Information/Additional Preferences

  • Project Management certification (e.g., PMP)
  • Prior experience in working with external business partners
  • Prior submission and inspection experience
  • Prior experience with the management of business plans
  • Strong self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed
  • Able to influence others without direct authority
  • Strong problem-solving skills; able to anticipate and recognize systemic problems, diagnose root causes and take corrective actions to prevent reoccurrence
  • Travel may be required