Job Description

This position is with Recordati Rare Diseases, Inc. (RRD), North America, an affiliate of Recordati.

At Recordati, we are united by a clear purpose: unlocking the full potential of life. With a century of history behind us, we are building the next chapter of our journey, continuing to grow while keeping patients at the centre of all we do.

What drives us is a shared belief that health, and the opportunity to live life to the full, should be within reach for everyone. This brings energy to our work, shaping how we support each other and show up every day. Our values – Better Together, Never Settle and Always Deliver – reflect this mindset, helping us to keep improving and make a meaningful difference.

Above all, these values bring to life our promise to everyone at Recordati, you can unlock your full potential. We know that people thrive when they can be themselves, are trusted and supported, and are given the opportunity to grow and make a meaningful contribution.

Are you ready to unlock your full potential?

Reporting Structure

Reports To: Director, Clinical Operations NA

Direct Reports: None

Areas Managed: Clinical trials in North America

Overview

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 RRD 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 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 RRD, 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
• Strong scientific background with at least five years of clinical development experience in oncology.
• 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, CFR, 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.

Work Environment

This job operates in a professional office environment. Based upon job requirements, employee may be required at times to attend meetings including travel out of province over weekends and nights. Employee must be able to freely operate and travel by car and train/plane modes of transportation. Employee is required to have a valid driver’s license and passport.

Physical Demands

The physical demands described here are representative of those required to successfully perform the essential functions of this position. The employee must be able to travel domestically and internationally, as business needs require. This position is primarily sedentary. The employee may occasionally move throughout office, meeting, or event locations and regularly operate a computer, telephone, and other office productivity equipment. The employee must be able to communicate effectively with internal and external stakeholders. Occasionally, the employee may be required to move or transport items weighing up to 25 pounds, with or without accommodations.

Location/Travel

• This position is located at RRD 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%); possible occasional international travel

FLSA Classification

• This position is considered Exempt.

EEO Statement

Recordati Rare Diseases values the diversity of its workforce and welcomes applications from all qualified applicants. It is the policy of Recordati Rare Diseases to provide equal employment opportunity (EEO) to all persons regardless of race, color, religion, sex, sexual orientation, gender identity, or national origin. Further, Recordati Rare Diseases will not discriminate on the basis of any characteristic protected by federal, provincial, or municipal law. Recordati Rare Diseases will provide reasonable accommodations for qualified individuals with disabilities.

Disclaimer

This job description is not designed to cover or contain a comprehensive listing of the activities, duties or responsibilities that may be required.

The expected salary range for this role is $109,800 - $164,700, depending on skills, competency, and market demand for your expertise.

In addition to base salary, compensation at Recordati Rare Diseases North America includes an annual bonus, along with a comprehensive benefits program that includes:

• 401(k) plan with a 100% company match on contributions up to 6%
• Medical, dental, and vision insurance
• Mental health and wellness benefits
• Generous paid time off and holiday policies
• Weeklong winter holiday shutdown
• Life and AD&D insurance
• Weekly complimentary lunch when on-site

We also offer additional programs that support your health, wellbeing, and work-life balance.

Recordati Rare Diseases North America is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

We are not accepting new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees, or Human Resources. Recordati Rare Diseases North America will not pay fees to any third-party agency or firm associated with unsolicited resumes.

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