Senior Manager, Site Start Up
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Job Description
Senior Manager managing study start-up activities and CRO partnerships for clinical trials at Parexel. Focused on timelines, compliance, and effective communication across teams.
Responsibilities:
- Accountable for advancing study start-up activities for outsourced trials
- Maintain timelines and successful execution with CRO partners
- Manage all matters related to CRO partners study start-up requirements
- Drive site activations through oversight of all activities
- Lead day to day project activities in the matrix
- Oversee start up activities with multiple CRO partners
- Evaluate performance, solve challenges, monitor timelines and progress
- Collaborating with functional colleagues for study completion
- Review and approve start up plans for projects
Requirements:
- Extensive pharmaceutical or related industry experience
- Extensive previous experience of working in a Start-up team, Clinical Trial Specialist, CRA, Clinical Trial Manager or similar having worked on global clinical trials.
- Experience in project management, CRO experience, change management or process design are beneficial
- The candidate must have a good working knowledge of clinical operations, clinical processes and medical terminology.
- Excellent knowledge of GCP and regulations
- Experience of controlled drug substances processed would be beneficial
- Experience of developing junior members of staff would be beneficial
- Experience of Regulatory Inspections
Benefits:
- Health insurance
- Retirement plans
- Professional development opportunities
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