Description

Manage investigator site activities for study participant enrollment, site maintenance, and closeout. Own the end-to-end start-up process for clinical sites.

Responsibilities

• Initiate site activities by collecting and submitting regulatory documents and negotiating informed consent documents.
• Act as the primary point of contact for site ERBs and Competent Authorities.
• Negotiate budgets and fully-executed contracts with site personnel and internal teams.
• Maintain inspection readiness by populating Trial Master Files and internal systems with accurate data.
• Drive timelines for site training and site initiation to align with company priorities.

Required Skills

• 5+ years of clinical research experience or relevant experience.
• Native Turkish speaker with full fluency in English.
• Bachelor's degree, preferably in a scientific or health-related field.
• Proficiency with TMF (Trial Master File) and CTMS.
• Experience managing Informed Consent documentation.
• Applied knowledge of project management processes and skills.
• Understanding of the clinical development paradigm and site initiation workflows.

Preferred Skills

• Knowledge of country-specific regulatory, data privacy, procurement, legal, and financial requirements.

Key Skills

Education

Bachelor's