Site Alliance Manager at Xcene Research

Job Purpose

• The Site Alliance Manager (SAM) is a key liaison between clinical trial sites, clinical research associates, the project management team, and the sponsor. This individual is responsible for ensuring compliance with research protocols, regulatory requirements and supporting trial deliverables.
• By fostering strong relationships with site staff, the SAM supports efficient study execution, monitors site performance and helps resolve operational challenges to ensure high-quality clinical research outcomes. This role reports to the Project Director.

Key Accountabilities

Site Engagement & Compliance:

• Serve as the primary point of contact between clinical trial sites and the CRA/PM team.
• Ensure compliance with study protocols, regulatory guidelines (ICH-GCP, FDA, EMA, etc.) and sponsor requirements.
• Support CRAs in site management activities, including issue resolution and escalation.
• Facilitate site training on protocol amendments, study updates and regulatory changes.

Operational Oversight:

• Monitor site performance and adherence to timelines, study objectives and deliverables.
• Identify and proactively address operational issues that may impact trial progress.
• Assist in the implementation of corrective and preventive actions (CAPA) when necessary.
• Ensure site documentation and essential regulatory files are maintained and audit-ready.
• Build and maintain strong relationships with site study team and Xcene study teams.
• Act as a liaison between sites and Xcene study teams, providing feedback on site concerns.
• Support site engagement strategies to improve site retention and performance.
• Identify risks to study conduct at the site level and implement mitigation strategies in collaboration with site and Xcene study team.
• Work closely with the quality assurance team (QA) to support audit preparation and regulatory inspections.
• Ensure data integrity and protocol adherence by conducting regular site assessments.

Key Competencies

• Strong site relationship management and engagement skills.
• Proficiency in clinical trial operations and regulatory compliance.
• Ability to anticipate challenges and proactively address them.
• Strong organizational skills and attention to detail.
• Ability to work collaboratively with CRAs, site staff and PM teams.

Education and Qualifications

• Bachelor's degree or higher in Nursing, Life Sciences, Pharmacy or a related field.
• Minimum 3–5 years of experience in clinical research with prior site management or CRA experience preferred.
• Strong knowledge of clinical trial regulations, Good Clinical Practice (GCP), and ethical guidelines.
• Excellent communication, problem-solving and interpersonal skills.
• Ability to work independently in a fast-paced environment while collaborating with cross-functional teams.
• Willingness to travel to clinical trial sites as required.