Global Study Start-Up Specialist

CCS Global; United Kingdom; Presencial; GBP 40.000 - 65.000; Jornada completa

Descripción de la vacante

CCS Global is seeking a Country Approval Specialist in the United Kingdom to support local regulatory submissions aligned with global strategy. You will coordinate submissions to MoH, EC and national applications, and collaborate with sites, CROs and Clinical Operations to ensure timely, compliant eTMF records and activation.

The role requires strong attention to detail, excellent communication, and knowledge of FDA/ICH-GCP guidelines, with 2+ years of relevant experience in regulatory affairs.

Formación

• Bachelor’s degree or equivalent.
• 2+ years of relevant experience.
• Understanding of the pharmaceutical industry (clinical development, drug distribution).
• Knowledge of Clinical Trial Agreements, budgeting and fair market value principles.
• Knowledge of FDA and ICH-GCP guidelines.

Responsabilidades

• Prepares, reviews and coordinates local regulatory submissions (MoH, EC, etc.) in alignment with global strategy.
• Collaborates with sites on document collection and review.
• Works with Study Startup, CROs and Clinical Operations to improve metrics and processes.
• Ensures SSU standards across projects.
• Reviews site essential documents for start-up (ICF, CVs, etc.).
• Tracks actions and communications to meet study/site timelines.
• Resolves escalated issues with CROs and Study Startup team.
• Reviews site performance metrics and maintains accurate eTMF for start-up.

Conocimientos

Oral and written communication

Interpersonal skills

Attention to detail

Computer skills

English language

Medical terminology

Teamwork

Organizational skills

Regulatory guidelines knowledge

Educación

Bachelor’s degree

Descripción del empleo

CCS Global is seeking a Country Approval Specialist in the United Kingdom to support local regulatory submissions aligned with global strategy. You will coordinate submissions to MoH, EC and national applications, and collaborate with sites, CROs and Clinical Operations to ensure timely, compliant eTMF records and activation.

The role requires strong attention to detail, excellent communication, and knowledge of FDA/ICH-GCP guidelines, with 2+ years of relevant experience in regulatory affairs.