Senior Site Manager

Principal Responsibilities

• Act as the primary local company representative for assigned clinical trial sites, ensuring strong site performance, regulatory compliance, and inspection readiness.
• Lead site feasibility activities, Site Qualification Visits (SQVs), and support Investigator Meetings (IMs), including preparation of materials and presentations as required.
• Provide end‑to‑end oversight of site execution, including start‑up, initiation, on‑site and remote monitoring, ongoing site management, and close‑out activities in accordance with ICH‑GCP, SOPs, and applicable regulatory requirements.
• Drive the implementation of risk‑based monitoring strategies and proactively manage, resolve, and escalate site‑level issues to ensure timely and effective resolution.
• Ensure continuous compliance with site staff training requirements and accuracy and completeness of training documentation across all trial phases.
• Partner closely with the Local Trial Manager and cross‑functional study teams to optimize site activation timelines and operational delivery.
• Maintain accountability for investigational product oversight, study supplies, data integrity, and timely safety reporting, including AEs, SAEs, and PQCs.
• Ensure completeness and quality of trial documentation, support audit and inspection readiness, and drive timely closure of corrective and preventive actions (CAPAs).
• Act as a subject‑matter expert for assigned protocols, contributing to mentoring, process improvement initiatives, and best‑practice sharing across sites.

Qualifications & Experience

• Bachelor’s degree in Pharmacy, Nursing, Life Sciences, Medical Sciences, or a related scientific discipline (or equivalent relevant experience).
• Minimum 4–5 years of clinical trial monitoring or site management experience; candidates with 4–5 years of hands‑on monitoring experience are strongly preferred.
• Proven experience supporting clinical trials from site start‑up through close‑out in compliance with GCP and regulatory requirements.
• Strong working knowledge of ICH‑GCP, company SOPs, local laws and regulations, study protocols, and monitoring guidelines.
• Oncology therapeutic area experience is an advantage.
• Demonstrated ability to manage multiple trials and sites in parallel while consistently delivering high‑quality results.
• Strong communication and interpersonal skills, with the ability to effectively engage investigators, site staff, and cross‑functional teams.
• Proficient in English and the local language, with strong written and verbal communication skills.
• Strong problem‑solving abilities with the capability to work independently and manage complex site‑level challenges.
• Proficient in clinical trial systems and standard office and reporting tools.
• Willingness to travel, including occasional overnight stays, as required by the role.