Fsp Sr Cra

PPD (Thermo Fisher)

Not specified; not specified; not specified
Prepare local regulatory submissions
Manage icf negotiations with ec/irb
Conduct site feasibility assessments
The role involves preparing, reviewing, and coordinating local regulatory submissions in alignment with global strategies while serving as the primary contact for investigators and authorities

Job Summary

  • The role involves preparing, reviewing, and coordinating local regulatory submissions in alignment with global strategies while serving as the primary contact for investigators and authorities.
  • Candidates will be responsible for developing country-specific Informed Consent Forms, negotiating with ethics committees, and ensuring timely site activations to meet critical path goals.
  • This position requires conducting site feasibility assessments, performing monitoring visits, and managing contractual negotiations to mitigate regulatory and financial risks.

Matching Summary

The role involves preparing, reviewing, and coordinating local regulatory submissions in alignment with global strategies while serving as the primary contact for investigators and authorities.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • Prepare local regulatory submissions
  • Manage ICF negotiations with EC/IRB
  • Conduct site feasibility assessments
  • Ensure compliance with ICH-GCP regulations
  • Coordinate site activation timelines

Nice-to-have

  • Mentoring junior staff members
  • Experience with gene therapy approvals
  • Strong stakeholder communication skills
  • Proactive issue resolution abilities

Key Requirements

  • Bachelor's degree required
  • 4+ years of clinical research monitor experience
  • Knowledge of PPD SOPs and client directives

Work Rights

Not specified

Tailored Resume

Cover Letter