Study Start-Up Specialist - Client-Dedicated

CCS-Global; United Kingdom; On-site; GBP 40,000 - 65,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Oral and written communication

Interpersonal skills

Attention to detail

Computer skills

English language

Medical terminology

Teamwork

Organizational skills

Regulatory guidelines knowledge

Education

Bachelor’s degree

Job description

As part of our global team, you’ll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy. As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals.

What You’ll Do:

• Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
• Work directly with assigned sites on all site related essential document collection and review.
• Partner with internal Study Startup team, CROs, Clinical Operations teams, and partners to improve overall metrics and deliver processes.
• Ensure standards are applied to the SSU processes across projects.
• Review site essential documents for start up including but not limited to: ICF, FDF, 1572, CVs and others.
• Promptly recognize and improve potential site activation delays and elevate to appropriate team members.
• Track all actions and communications with sites to ensure timelines are achieved for studies and sites assigned.
• Support resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team.
• Review and provide feedback to management on site performance metrics.
• Ensure accuracy and completeness of the eTMF for assigned sites during start up.

Education and Experience Requirements:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
• Understanding of the pharmaceutical industry (e.g., clinical development, the prescription drug distribution process, etc.)
• Understanding of Clinical Trial Agreements, budgeting and fair market value principals.
• Knowledge or FDA and ICH-GCP guidelines for conducting clinical research.

Knowledge, Skills and Abilities:

• Effective oral and written communication skills
• Excellent interpersonal skills
• Strong attention to detail and quality of documentation
• Good computer skills and the ability to learn appropriate software
• Good English language and grammar skills
• Basic medical/therapeutic area and medical terminology knowledge
• Ability to work in a team environment or independently, under direction, as required
• Basic organizational and planning skills
• Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations