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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Clinical Trial Registry & Transparency Senior Manager


Reference:SCA013665 Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Clinical Trial Registry & Transparency Senior Manager

Our global pharma client are continuing to grow their team and are currently recruiting for a
Clinical Trail Registry (CTRT) and Transparency Senior Manager. As Clinical Trail Registry (CTRT) and Transparency Senior Manager, you will be responsible for working with cross-functional, multidisciplinary teams to facilitate the delivery of CTRT and Transparency documents and will draw upon information from multiple internal and external sources to lead and provide technical coaching to the CTRT and Transparency writing team to ensure the release of scientific information and the delivery of the regulatory requirements. You will collaborate and influence teams, and work closely with other managers and Leads across Global Scientific Communications (GSC) to ensure best practices across the function. Prior people management is required. This is a permanent role with hybrid working.

Responsibilities

  • Develop and execute sourcing plans in partnership with GSC leads to ensure seamless delivery of asset plan and priorities
  • Collaborate with function, capability, and site leadership to ensure alignment of business planning and operations
  • Coordinate across and develops synergies with therapeutic areas, phases of development, and geographies
  • Adjust work plan based on shifting priorities using effective change control
  • Lead and direct internal and external team members in achieving team goals
  • Identify and resolve issues impacting delivery of work
  • Conceive and implement new and efficient ways to accomplish goals
  • Partners in the selection process and may manage relationship for preferred vendors.
  • Regularly reports results of team activities/metrics to leadership and stakeholders
  • Manage audit readiness, quality, and compliance to ensure deliverables are accurate, transparent, of high quality, and in compliance with internal/external guidance/regulation
  • Recruit, develop, and retain a strategic and operationally capable workforce skilled and knowledgeable in scientific communications
  • Effectively creates and manage an agile organization that continuously meets the needs of a changing portfolio
  • Provide input on employee development, talent assessment, and succession planning activities
  • Provide guidance, training, and supervision to personnel
  • Appropriately manage the workload of direct reports; monitor project timelines and quality, and communicate priorities to direct reports
  • Provide technical support and guidance to direct reports as needed
  • Evaluates performance by reviewing documents and attending writing team meetings, and recommends developmental actions for all assigned staff.
  • Ensure all direct reports are compliant with company policies, procedures and regulations
  • Develop new and emerging capabilities to support the effectiveness of GSC

Requirements
  • Master’s degree in a scientific, health, communications, technology, health outcomes, or public health related field
  • Advanced degree (MBBS, MD, PharmD, PhD, MPH)
  • Background in clinical Data Disclosure & Transparency and Redaction
  • 3 years’ experience in clinical research
  • 2 years’ experience in leading/managing a key part of portfolio or business process
  • Experience leading others, including relationship and team building, setting expectations, holding others accountable, and technical coaching
  • Strong scientific communication skills, including extensive experience in writing, reviewing, and publishing scientific materials and the ability to appraise scientific literature and raw data critically
  • Ability to communicate clearly and succinctly with all audiences and forums through exemplary oral and written communication skills
  • Strong medical research background with demonstrated breadth and depth of knowledge of medical research processes throughout all phases of development
  • Expertise in industry standards and best practices, compliance issues, and regulatory requirements
  • Strong leadership, problem-solving skills, negotiation/influence/motivation, project management and critical thinking skills with ability to use effectively in a team, cross-functional setting and/or global environment
  • Project management experience
  • Experience managing business plans, budgeting and capacity resourcing
  • Experience in the global environment and an appreciation for global diversity
  • Ability to be flexible in varying environments and with multiple customer groups with ability influence cross functionally at all levels
  • Ability to work well across cultures and time zones
  • Highly organized and able to manage multiple projects at any given time
For more information, contact Sinéad Cullen on +353879500821 or [email protected]