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Contact Info
Karen Shiel
Life Science

+353 1 5079256
[email protected]
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Details

Clinical Program Manager


Reference:KS/AFLD-751644 Location: Dublin
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed

Our client is a leading Global Biopharma organisation. The Clinical Operations team in Dublin is a pivotal function within the Paediatric Centre of Excellence and is responsible for the management and execution of Paediatric Clinical Trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures that all clinical trial activities are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of our clients products.

The Clinical Program Manager will be a valued member of the Clinical Operations team in Dublin. The successful person will work with the Clinical Trial Manager and study teams to manage studies within a program and across all regions, providing a significant role in oversight and management of programs, leading cross-functional teams, driving performance and ensuring consistent execution of delivery.

Role/Responsibilities

  • Provides guidance and oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines.
  • Provides Clinical Operations therapeutic area leadership.
  • Accountable for successful study completion including clinical trial budgets and timelines.
  • Leads cross-functional study management teams and should have good influencing skills with study stakeholders.
  • Ensures consistent execution of program requirements across studies in a program.
  • Manages study resources and responsible for career development and guidance of direct reports.
  • Partners with functional peers to manage, adjust, and revise project timelines/budgets as necessary.
  • Communicates project status and issues and ensures project team goals are met.
  • Writes study protocols, study reports, sections for investigator brochures and regulatory documents (e.g. IND, NDA, etc.) with little supervision.
  • Develops and progresses RFPs and selection and management of CROs/vendors.
  • Anticipates moderately complex obstacles and implements solutions to achieve project goals.
  • Resolves problems using national and international regulations, guidelines and investigator interaction.
  • Contributes to development of abstracts, presentations, and manuscripts.
  • Participates in and/or leads departmental or interdepartmental strategic initiatives.
  • May design and use all available vehicles for scientific communication within company.
  • May design scientific communications.
  • Travel is required.
Education/Experience:
  • BSc or BA in a relevant scientific discipline or RN qualification.
  • At least seven years relevant clinical trial experience in the pharmaceutical industry.
  • Ability to manage and motivate teams and drive performance.
  • Ability to develop study team members.
  • Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials.
  • Excels in project management and demonstrates ability to manage studies or programs of greater complexity from both a process and strategic perspective.
  • Demonstrates knowledge of how the clinical trial operations impact the broader strategic goals of the Company.
  • Ability to work independently with minimal oversight, identify issues and adapt to changes.
  • Demonstrates an ability to interact with contacts cross-functionally at senior levels within the Company.
  • Ability to examine functional issues from a broader organizational perspective.
  • Must have functional expertise to initiate, author, or contribute to SOP development, implementation and training.
  • Excellent teamwork, communication, decision-making and organizational skills are required.
  • Knowledge of FDA and/or EMEA Regulations, ICH Guidelines and GCP governing the conduct of clinical trials.
  • Strong communication and influence skills and ability to create a clear sense of direction is necessary.
  • Excellent interpersonal skills and demonstrated ability to lead is required.
  • Excellent verbal, written and presentation skills are required.

For further details please contact Karen Shiel on 087 7452487 or send CV in confidence to: [email protected]