The Site Management Lead provides Site Monitoring expertise to and consults the Trial Team, leads and oversees the implementation of the Site Monitoring & Oversight approach and activities as part of overall clinical trial quality management. The role contributes to the overall success and delivery of their assigned clinical trials according to defined milestones and key performance indicators.
The SML is responsible for managing the trial level planning, implementation, issue management, and oversight of the Site Monitoring activities of a trial as assigned, to safeguard the protection of the trial subject, reliability of the trial results, compliance with study protocol, sponsor obligations, ICH-GCP and applicable regulations and manages inspection readiness at all times.
Main Responsibilities
Trial Preparation
- Lead planning of trial quality and risk monitoring/mitigation.
- Accountable for development and implementation of operational Site Monitoring & Oversight plans.
- Deliver training and guidance to CT Managers and CRAs.
- Independently author and review trial-level documents.
- Act as subject matter expert on site management and monitoring topics.
- Join and presents at global/regional/local Trial Team meetings and Investigator Meetings.
- Integrate patient/site level feedback to the documents ensuring design with a focus on the patient and patient safety.
- Represent monitoring strategy in global/regional/local meetings.
- Timely responses to Site Management and monitoring questions from external and internal stakeholders (including Regulatory Authority/Ethics Committee).
- Facilitate communication and direction with Clinical Trial Leaders, Clinical Operations Coordinators, CT Managers and CRAs.
Trial Conduct
- Independently oversee CRO performance and adherence to ICH-GCP and SOPs.
- Drive issue management and resolution at trial level.
- Proactively identify trial and site level risks and implement mitigation strategies.
- Maintain and update Site Monitoring plan and trial-level documents to ensure and maintain Risk-based Site Monitoring approach for the trial
- Conduct oversight visits and ensure follow-up actions.
- Lead preparation and implementation of trial document amendments and retraining.
- Provide strategic communication and training.
- Communication with Clinical Trial Leaders, Clinical Operations Coordinators, CT Managers and CRAs, perform re-training etc.
- Participate, prepare input and (co-) lead Trial Oversight Meetings (country and trial level) and contribute to the timely responses to questions from external and internal stakeholders (including Regulatory Authority/ Ethics Committee).
Trial Close-out
- Coordinate timely cleaning and delivery of clinical trial data with Trial Team and countries.
- Support compilation and review of the quality section for the clinical trial report for site monitoring activities.
Qualifications and Requirements
University degree in life sciences or related field OR equivalent professional education with extensive experience in clinical operations and site monitoring required.
At least five years of relevant clinical operations experience.
Fluent in English.
Strong leadership and influencing skills.
Deep knowledge of ICH-GCP, regulatory requirements, and risk-based monitoring.
Profound CRA background with Lead level CRA responsibilities, combined with initial exposure to selected tasks in Clinical Trial Management.
Initial experience in portions of Clinical Trial Management
Proven ability to manage complex trials across regions and vendors.
Demonstrates AAI approach in leading and decision-making.
