Clinical Trial Liaison Manager

We need to output only HTML fragment, with headings

for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title. Must preserve all substantive info, no boilerplate, no EEO, etc. Must not include sections with filler like "commensurate with experience". We need to extract content. Let's parse the posting. First part: repeated intro about Recordati purpose etc. That's generic fluff, but maybe we can include as "About the role"? The instructions: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). We should include sections only when posting has real specific content for it. The intro about company purpose is generic but could be considered "About the role"? However it's more about company. Might be considered boilerplate? Not sure. The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The intro about purpose is not exactly boilerplate but it's generic fluff repeated twice. Might be considered not substantive? The instruction says preserve ALL substantive information; do NOT invent or summarize away detail. The intro about purpose is not specific to the role; it's generic company description. Might be considered not substantive for the role. However we could still include an "About the role" section summarizing the 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. That's substantive. So we can put that under

About the role

with

. Then Responsibilities: The "Essential Duties And Responsibilities" section with bullet list. We'll convert to

• . Requirements: Might be covered by Education And Experience? That's qualifications. The posting has "Education And Experience" and "Knowledge And Skills". Those could be Requirements and Qualifications and Skills. We need to decide sections. We have sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We have Education And Experience (Bachelor's degree required, preferably in life/physical sciences; Strong scientific background with at least five years of clinical development experience in oncology; Extensive clinical development and pharmaceutical experience with good knowledge of applicable regulations; 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.) That could go under Requirements or Qualifications. Usually Requirements = mandatory; Qualifications = preferred. We'll split: Requirements: Bachelor's degree required, preferably in life/physical sciences; Strong scientific background with at least five years of clinical development experience in oncology; Extensive clinical development and pharmaceutical experience with good knowledge of applicable regulations; Experience working on audits, regulatory inspections, and CAPAs; Experience working on Phase 1-4 clinical development studies. Qualifications (preferred): 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. Skills: Knowledge And Skills section: 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. Benefits: Provided: "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." Pay: "The expected salary range for this role is $109,800 - $164,700, depending on skills, competency, and market demand for your expertise." Schedule: Not explicitly given. There's 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". That's about location/travel, not schedule. There's no explicit schedule like full-time, part-time, shift. So we should not create a Schedule section because no specific schedule info. The instruction: never create Pay/Schedule/Benefits sections unless the posting actually states them. Pay is stated, Benefits stated, Schedule not stated, so omit Schedule. Also we have "FLSA Classification This position is considered Exempt." That's not a section we have; could be included in About the role or maybe as a note. But we can include it in About the role paragraph. We also have "Location/Travel" details. Could be included in About the role or maybe a separate section? Not among allowed headings. We could incorporate into About the role. We must not include boilerplate like EEO, Disclaimer, etc. Remove those. We must not repeat duplicated lines. The intro appears twice; we will only include once. Now produce HTML fragment:

  About the role

  ...

  Responsibilities

  • ...
  ...

  Requirements

  • ...
  ...

  Qualifications

  • ...
  ...

  Skills

  • ...
  ...

  Benefits

  • ...
  ...

  Pay

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

  We must not include any extra text outside HTML. Now craft content precisely, preserving all substantive info. Let's extract About the role content: From posting: "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." Also there is location/travel: "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" Also FLSA Classification: "This position is considered Exempt." We can incorporate location/travel and FLSA into About the role paragraph. Now Responsibilities list: The "Essential Duties And Responsibilities" includes several bullet-like sentences. Let's list them: - Contributes to operational trial deliverables at clinical trial sites according to timelines, budget, operational procedures, quality/compliance, and performance standards. - Assigned key responsibilities include: Actually that's a heading. Then subpoints: 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 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 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) 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 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 We need to preserve all substantive info; we can flatten into a list of duties. Might be long but okay. Now Requirements (mandatory): - 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 Now Qualifications (preferred): - 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 - Working with rare diseases Now Skills: - Proficiency in Microsoft Office suite, basic computer and typing skills, and tools/systems for managing clinical trials