Job description

Clinical Operations Lead III/ Clinical Study Start-up PM

Location: 100% remote

Contract: 16 - 18 months

JOB SCOPE:

This role is a senior member of the Clinical Trial Accelerator Unit (CTAU) taking broad responsibility for accelerating study start up activities, harmonizing processes and providing start-up expertise to studies and programs to which they are assigned, to ensure study teams meet and exceed the PRA-FPI timelines mandated. In addition, the Study Start Up manager (SSU) is expected to track, observe, and identify opportunities to innovate and improve overall clinical trial delivery velocity across the portfolio. In this capacity, the SSU manager oversees, manages, and provides key strategic input into key study start-up activities including feasibility, site selection, site contracting, vendor set-up, informed consent management, and overall site engagement. In addition, adapts and maintains the GCO study Gant chart and dashboard, maintaining responsibility for the progression of the fast to start clinical sites, and communication of all timeline objectives to the study team.

The SSU manager assists the CTAU head in driving continuous improvement efforts to ensure competitive operational performance relative to industry benchmark cycle times.

The SSU manager develops collaborative relationships with the multi-disciplinary study team to ensure focus on the fast to start timeline and to help resolve and/or escalate issues with a potential to delay study start up.

EDUCATION:

• B.A. or B.S. in a scientific discipline; advanced degree preferred.
• Scientifically and clinically astute with very strong project management skills.

Experience:

• At least 10 years of clinical research study management experience of which at least 4 years has been with a sponsor company managing outsourced clinical trials within quality, timeline, and budget expectations.
• Prior CRO or investigator site and/or monitoring experience is a plus.

Job Types: Full-time, Contract

Salary: $90.00 - $100.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• clinical research study management: 10 years (Required)
• a sponsor company managing outsourced clinical trials: 4 years (Required)
• Prior CRO or investigator site and/or monitoring: 2 years (Preferred)
• Project Management: 2 years (Required)

Work Location: Remote

offroadmanagementgroup.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, offroadmanagementgroup.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, offroadmanagementgroup.com is the ideal place to find your next job.