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Details
Associate Director Clinical Development
Reference: | SCA013962 | Location: |
Cork |
Qualification: | Degree | Experience: | 5-7 Years |
Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
Clinical Project Manager, Clinical Research Associate, Clinical Research Nurse, Clinical Trials Advisor
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
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