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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Associate Director Clinical Development


Reference:SCA013962 Location: Republic of Ireland
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Clinical Project Manager, Clinical Research Associate, Clinical Research Nurse, Clinical Trials Advisor, Study Start Up Manager, Study Start Up Specialist, Study Start Up Team Lead

Associate Director Clinical Development
Our client, a global pharma company, are continuing to add talented clinical professionals to their Clinical Development team, and are currently recruiting for an Associate Director to join their team on a permanent basis. You will have experience working in Clinical Trials/Clinical Research/Clinical Operations/Clinical Development and be an experienced people manager/team lead. This role is hybrid working, however, if you are living outside of the Republic of Ireland, relocation to Ireland is essential.

Responsibilities:

  • Partner with functional, cross-functional and team leadership to provide operational input into the feasibility and resource requirements associated with clinical plans
  • Provide strategic direction and leadership to CTPMs to enable them to drive the implementation of the Regional/Global enrollment strategy, to accomplish milestones to plan. Escalates related issues to appropriate parties for awareness and resolution
  • Collaborates with Medical Sourcing, Procurement, CPM, and compound Team Management to provide and enable decisions related to internal/external-sourcing options
  • Work closely with the clinical project manager to ensure planning databases are accurate and up-to-date
  • Work to align resources based upon team prioritization decisions and regional participation in the trial
  • Manage study management personnel workload based on portfolio, global and regional requirements and expertise level of the individual
  • Facilitate discussions within functional counterparts to manage team priorities and address unplanned demands
  • Recruit, retain and develop top talent to ensure a high performing team culture
  • Facilitate problem-solving, shared learning and decision-making across clinical functions
  • Participate in risk assessments at the clinical plan level and ensures development and implementation of cross-functional risk management plans at the trial level
  • Ensure inspection readiness of respective study team(s). Oversees and coaches CTPMs in the timely documentation of deviations, creation of story boards or issue summary documents (e.g. for high risk areas/hot topics)
  • Oversee and provide direction in obtaining appropriate personnel involvement as compliance issues are identified which require further action or follow-up
  • Ensure that team members adhere to and complete trainings related to GCPs, global SOPs, and clinical best practices

Requirements
  • Bachelors or University degree (scientific or health-related field preferred) and 5 years clinical research experience or relevant experience in a scientific or health-related field; or an advanced degree
  • Minimum of 5 years clinical trial experience with a strong working knowledge of the clinical research process
  • Demonstrated technical and process expertise in clinical trial development. Must understand the drug development process and interdependencies of various tasks and functional groups.
  • Strong communication skills. Communicates effectively up and down in an organization and maintains confidentiality with respect to strategic and personnel matters
  • Proven ability to coach others
  • Strong people and leadership skills with demonstrated ability to influence and lead across clinical functions.
  • Strong interpersonal, teamwork, and negotiation skills
  • Strong self-management and organizational skills
  • Must be capable of managing staff virtually and across-borders and cultures, demonstrating an understanding of cultural differences
  • Previous supervisory experience
  • Global clinical trial experience
  • Prior experience with the management of business plans
  • Demonstrated strong business skills including the ability to understand and facilitate planning processes across clinical functions
For more information, please contact Sinéad Cullen on +353879500821 or [email protected]