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 endtoend oversight of site execution including startup initiation onsite and remote monitoring ongoing site management and closeout activities in accordance with ICHGCP SOPs and applicable regulatory requirements.
• Drive the implementation of riskbased monitoring strategies and proactively manage resolve and escalate sitelevel 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 crossfunctional 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 subjectmatter expert for assigned protocols contributing to mentoring process improvement initiatives and bestpractice sharing across sites.

Qualifications & Experience

• Bachelors degree in Pharmacy Nursing Life Sciences Medical Sciences or a related scientific discipline (or equivalent relevant experience).
• Minimum 45 years of clinical trial monitoring or site management experience; candidates with 45 years of handson monitoring experience are strongly preferred.
• Proven experience supporting clinical trials from site startup through closeout in compliance with GCP and regulatory requirements.
• Strong working knowledge of ICHGCP 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 highquality results.
• Strong communication and interpersonal skills with the ability to effectively engage investigators site staff and crossfunctional teams.
• Proficient in English and the local language with strong written and verbal communication skills.
• Strong problemsolving abilities with the capability to work independently and manage complex sitelevel challenges.
• Proficient in clinical trial systems and standard office and reporting tools.
• Willingness to travel including occasional overnight stays as required by the role.