Global Study Start-Up Specialist

ICON Strategic Solutions; South Africa; Sur place; ZAR 350 000 - 550 000; Plein temps

Avantages offerts par ce poste

Annual leave entitlements

Health insurance

Retirement planning

Employee Assistance Programme LifeWor­

Life assurance

Country-specific benefits

Résumé du poste

ICON Strategic Solutions is seeking a Study Start Up Associate to drive site start-up and activation activities across trials, ensuring regulatory compliance and timely study initiation. You will collaborate with cross-functional teams and external stakeholders to deliver high-quality submissions.

You will bring hands-on experience in regulatory submissions (CTF 1-3), site activation, and coordinating with Ethics Committees/IRBs, regulatory authorities, and study teams.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Experience in Study Start-Up / Site Activation in a clinical research environment.
• Proven track record completing CTF 1, 2 and 3 submissions from start to finish.
• Experience preparing, reviewing, coordinating and submitting all required documentation across the CTF submission stages.
• Strong regulatory and documentation knowledge for trial start-up.
• Experience coordinating with sites, Ethics Committees/IRBs, Regulatory Authorities and internal teams.
• Ability to manage multiple studies/sites and submission timelines in a fast-paced environment.
• Excellent communication and interpersonal skills.

Responsabilités

• Deliver site start-up and activation work to a high standard with the team.
• Prepare and submit regulatory documents such as clinical trial applications and ethics submissions.
• Coordinate with stakeholders to obtain approvals for study initiation.
• Maintain accurate records of regulatory submissions and approvals.
• Support study teams in developing study documents (protocols, informed consent forms, investigator brochures).
• Participate in start-up meetings and provide input on regulatory timelines.

Connaissances

Study Start-Up / Site Activation

CTF submissions (1-3)

Regulatory documentation coordination

Stakeholder coordination

Multi-study management

Attention to detail

Regulatory knowledge for trials

Communication skills

On-site work flexibility

Formation

Bachelor's degree in Life Sciences

Description du poste

ICON Strategic Solutions is seeking a Study Start Up Associate to drive site start-up and activation activities across trials, ensuring regulatory compliance and timely study initiation. You will collaborate with cross-functional teams and external stakeholders to deliver high-quality submissions.

You will bring hands-on experience in regulatory submissions (CTF 1-3), site activation, and coordinating with Ethics Committees/IRBs, regulatory authorities, and study teams.