Senior Study Start-Up Lead — Remote in Spain

Remote Jobs; United States; Remote; USD 68,000 - 101,000; Full time

Job summary

Parexel is seeking a Senior Study Start-up Specialist to operate in a country-level capacity, following project requirements and local regulations with minimal oversight. The role may include mentoring SSU Specialists and coordinating regulatory and contract activities for sponsor-driven trials.

The candidate should have extensive regulatory and start-up experience, strong knowledge of GCP, and the ability to work independently in a fast-paced environment.

Qualifications

• Bachelor’s degree or equivalent; 3–5 years in regulatory & start-up.
• Pharmaceutical or related industry experience.
• Experience in Start-up teams and in-house trials/process design.
• Excellent knowledge of GCP and regulations.
• Ability to mentor, lead and motivate junior staff.
• Ability to work independently in a fast-paced environment.

Responsibilities

• Coordinate site feasibility collation and tracking.
• Ensure CDA is in place for submissions.
• Manage regulatory/CA/EC submission information in CTIS and related systems.
• Prepare and submit regulatory packets and site contracts.
• Liaise with regulatory and legal teams to authorize documents.
• Maintain Trial Master File documentation (TMF).
• Support start-up planning and essential document checklists.

Skills

Regulatory start-up

GCP knowledge

Independent work

Problem solving

Mentoring

Pharmaceutical industry experience

Education

Bachelor's degree

Regulatory start-up experience 3–5 years

Job description

Parexel is seeking a Senior Study Start-up Specialist to operate in a country-level capacity, following project requirements and local regulations with minimal oversight. The role may include mentoring SSU Specialists and coordinating regulatory and contract activities for sponsor-driven trials.

The candidate should have extensive regulatory and start-up experience, strong knowledge of GCP, and the ability to work independently in a fast-paced environment.