Senior Manager, Study Start Up
Parexel
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Oversee a portfolio of client studies where the client have given operational responsibility to our CRO partners for trial execution.
- Support development of infrastructure, processes, teams and appropriate technology to assist in the effective oversight of out-sourced studies.
- Work collaboratively with the CRO project teams to maintain timelines and ensure that start-up activity is progressing as expected per the startup plan.
- Manage a team of Oversight Managers to support program delivery with our CRO partners in successful execution of awarded studies.
- Accountable for advancing study start-up activities for outsourced trials by understanding the objectives and assisting in the review and approval of the plan for country and site activation.
- Collaborates effectively with cross-functional teams, CRO partners, and regional colleagues to advance study start-up activities, oversee site activation processes, and ensure timely execution of clinical trials that align with project objectives and regulatory requirements across diverse global landscapes.
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
- Degree (BSc) or equivalent experience gained through time in industry (>5yrs)
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical operationsclinical processesmedical terminologyproject managementchange managementprocess designGCPregulatory inspectionscontrolled drug substancesteam management
Soft skills
collaborationleadershiporganizational skillscommunicationoversightproblem-solvingteam developmentaccountabilityadaptabilitytime management