Senior Manager, Site Start Up

This is a fully remote position, open to applicants in California.

📋 Description

• Responsible for enhancing study start-up initiatives for outsourced trials.

• Ensure timelines are met and successfully executed in collaboration with CRO partners.

• Handle all aspects related to the study start-up requirements of CRO partners.

• Propel site activations by overseeing all related activities.

• Direct daily project operations within the matrix.

• Supervise start-up activities across multiple CRO partners.

• Assess performance, address challenges, and monitor timelines and progress.

• Collaborate with functional colleagues to ensure study completion.

• Review and authorize start-up plans for projects.

⛳️ Requirements

• Extensive experience in the pharmaceutical or related industry.

• Significant prior experience working in a Start-up team, Clinical Trial Specialist, CRA, Clinical Trial Manager, or similar roles with a focus on global clinical trials.

• Project management experience, along with CRO experience, change management, or process design, is advantageous.

• The candidate should possess a solid understanding of clinical operations, clinical processes, and medical terminology.

• In-depth knowledge of GCP and relevant regulations.

• Experience with controlled drug substances is a plus.

• Experience in mentoring junior staff members is beneficial.

• Familiarity with Regulatory Inspections is desirable.

🏝️ Benefits

• Health insurance.

• Retirement plans.

• Opportunities for professional development.