The Clinical Trial Liaison Manager (CTLM) is a Hybrid office-based position with regular travel in the field. The role is based in North America, overseeing site trial delivery, subject recruitment, protocol adherence, and data quality. The CTLM represents the company in site relations, supports study teams with startup and recruitment, and manages in-field activities of the contracted CRO, focusing on the CRA team. The CTLM also addresses unresolved investigator concerns, engages with PIs for study updates and recruitment plans, and supports local site staff and trial team members. Additionally, the role provides project management support across the Medical and Clinical organization and ensures compliance with project plans, regulatory requirements, GCP, SOPs, and company policies.

Essential Duties and Responsibilities
Contributes to operational trial deliverables at clinical trial sites according to timelines, budget, operational procedures, quality/compliance, and performance standards. Assigned key responsibilities include:

1. Site and Investigator Relationship Management

   • Acts as an ambassador for the company, supporting its positioning as a sponsor of choice, and representing the sponsor with investigators and site staff.
   • Drives enrollment at the principal investigator (PI) level, collaborating closely with clinical research associates (CRAs) and study coordinators.
   • Facilitates collaboration between departments or groups within the same trial site to optimize subject enrollment.
   • Maintains accountability for long-term operational partnerships with key sites, providing local intelligence.
   • Leads strategic partnerships with key sites to implement collaborative initiatives for clinical trial execution.

2. Patient Recruitment and Enrollment

   • Oversees and tracks patient recruitment for sites, proactively identifying ways to prevent delays.
   • Supports the development of recruitment and retention plans in collaboration with Lead CSM, CSM vendor/CRO, or Local CSM.
   • Conducts motivational or booster visits upon request by the sponsor.
   • Reports local site situations and provides insights on recruitment challenges and solutions.

3. Monitoring and Compliance

   • Ensures data quality and integrity meet Good Clinical Practice (GCP) standards and local regulations through data reviews (remote and onsite).
   • Oversees the activities of local CRO teams to ensure effective sponsor oversight of monitoring activities.
   • Conducts Sponsor Oversight Monitoring Visits (SOVs) to ensure accurate and compliant monitoring, including source data verification (SDV) as needed. Accurately creates and documents progress in clinical trial monitoring system and follows up on open issues through resolution.
   • May attend pre-study visits (PSVs), site initiation visits (SIVs), interim monitoring visits (IMVs), and close-out visits (COVs).
   • Identifies trial issues proactively, seeks solutions, and escalates them to the appropriate authorities (Lead CSM, CSM vendor/CRO, or Local CSM).

4. Collaboration and Best Practices Sharing

   • Collaborates with other CTLMs, Lead CSM, CSM vendor/CRO, or Local CSM to share best practices and beneficial experiences.
   • Supports CRAs and local CRO team members to aid trial delivery and compliance.

5. Audits, Inspections, and Quality Assurance

   • May assist with quality assurance, audit and inspection preparations, including generating and implementing Corrective and Preventive Action (CAPA) plans.
   • May attend audits and inspections as required.
   • Adheres to company SOPs.

Education and Experience

• Bachelor's degree required, preferably in the life/physical sciences.
• Nursing or PharmD preferred but not mandatory.
• Strong scientific background with at least five years of clinical development experience.
• Extensive clinical development and pharmaceutical experience with a good knowledge of the applicable regulations in order to have a thorough understanding of the processes associated with executing clinical development plans.
• Experience working on audits, regulatory inspections, and CAPAs.
• Experience working on Phase 1-4 clinical development studies.
• Highly desirable but not required: Experience supporting regulatory submissions, previous roles working as a CTLM, study coordinator, research nurse, or in Med Affairs Operations, formal Project Management training or certification, and working with rare diseases.

Knowledge and Skills

• Proficiency in Microsoft Office suite, basic computer and typing skills, and tools/systems for managing clinical trials.
• Strong written and verbal English communication and presentation skills.
• Extensive knowledge of GCP regulations and ICH Guidelines.
• Skilled at conflict resolution, collaborating with stakeholders with varying viewpoints, influencing with and without authority, and negotiation. Includes relationship management of multiple stakeholders, internally and externally, such as KOLs, networks, PAGs (Patient Advocacy Groups), CROs, and others.

Location/Travel

• This position is located at the HQ office in Bridgewater, New Jersey, with an average of 3 days per week in the office expected. The position requires domestic travel (up to 40%); occasional international travel.

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