Global Study Start-Up Leader (Remote)

Parexel; United States; Remote; USD 57,000 - 64,000; Full time

Benefits offered by this job

Medial care plan

Life Assurance

Excellent training

Job summary

Parexel is seeking a Study Start-Up Leader (SSU) to drive the global site activation for assigned trials, ensuring timely start-up and regulatory submissions. The role requires strategic planning, oversight of TMF and documentation, and collaboration with cross-functional teams and CRO partners.

Ideal candidates have 4–6 years of global SSU management and regulatory submission experience, with strong project management and leadership skills.

Qualifications

• Bachelor degree in a relevant field
• Minimum 4–6 years global SSU management and regulatory submission experience
• Regulatory document management experience
• Strong project management and clinical trial management experience
• Demonstrated leadership and cross-functional collaboration abilities
• Experience with regulatory guidelines (ICH-GCP) and TMF/CTMS

Responsibilities

• Develop the site start-up strategy for each study with dependencies and risk mitigation.
• Oversee country start-up strategies and regulatory submissions planning.
• Lead site start-up management including documentation and TMF filing.
• Represent SSU on cross-functional teams and escalate issues.
• Support process improvements and cross-functional collaboration.
• Travel up to 25% as required.

Skills

Project management

Clinical trial management

Regulatory submissions

Cross-functional leadership

Vendor management

CTMS / TMF systems

Communication skills

Education

Bachelor degree

Tools

CTMS

TMF

MS Office (PowerPoint, Word, Excel)

Job description

Parexel is seeking a Study Start-Up Leader (SSU) to drive the global site activation for assigned trials, ensuring timely start-up and regulatory submissions. The role requires strategic planning, oversight of TMF and documentation, and collaboration with cross-functional teams and CRO partners.

Ideal candidates have 4–6 years of global SSU management and regulatory submission experience, with strong project management and leadership skills.