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    Clinical Trial Manager Ii (Ctm Ii)

    Caidya
    2+ years
    Not Disclosed
    Remote
    10 Nov. 4, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Clinical Trial Manager II
    Location: Remote

    Job Overview:
    The Clinical Trial Manager II (CTM II) leads and manages monitoring services for clinical projects, ensuring high-quality and timely delivery of project-specific on-site and remote monitoring services. This role involves direct communication with investigative sites, Clinical Research Associates (CRAs), and the project Sponsor, overseeing compliance with Caidya and sponsor SOPs, guidelines, and project plans. Responsibilities include training compliance for the clinical monitoring team, tracking critical project tasks, and supporting study enrollment efforts.

    Key Responsibilities:

    • Ensure project consistency by adhering to Caidya and sponsor SOPs and guidelines across assigned projects.
    • Create and manage the Clinical Monitoring Plan (CMP), reviewing and updating it regularly.
    • Provide input to the Project Manager (PM) on the Project Management Plan (PMP).
    • Review CRA trip reports, managing resolutions and escalating issues as necessary.
    • Monitor protocol deviations and track action items and FAQs, escalating as needed.
    • Oversee the clinical portion of the Trial Master File (TMF) and conduct periodic completeness reviews.
    • Analyze enrollment activities and trends, developing strategic plans to meet enrollment targets.
    • Develop and distribute study newsletters.
    • Ensure appropriate CRA staffing, managing resource projections and planned attrition.
    • Assure quality in clinical monitoring deliverables and identify/mitigate risks.
    • Manage monitoring team site assignments and visit schedules to meet CMP metrics.
    • Conduct co-monitoring visits and provide team training to assure quality and mitigate risks.
    • Coach and mentor the monitoring team, developing project-specific training materials.
    • Provide performance feedback to CRAs, the PM, and line management.
    • Lead internal team and Sponsor calls, serving as the primary contact for protocol clarifications and site issues.
    • Coordinate and manage the clinical monitoring budget and scope of work.
    • Assist the PM with budget coordination, grant administration, and invoicing.
    • Track monitoring services billing units and report to the Project Manager monthly.
    • Participate in monthly project review meetings, providing budget projections for monitoring services.
    • Collaborate with the Lead Data Manager on CRF Completion Guidelines and specifications.
    • Deliver the Clinical Monitoring portion of bid defense presentations.
    • Build relationships with regulatory authority and IRB/IEC personnel within local guidelines.
    • Attend project and departmental meetings and maintain training requirements.
    • Assume CRA responsibilities as needed and perform other project-related duties.

    Supervisory Responsibilities:

    • Provide project work direction to regional/office-based CRAs, Internal Clinical Research Associates (ICRAs), and Clinical Trial Associates (CTAs).

    Job Requirements:

    Education:

    • College degree preferred, ideally in healthcare or life sciences, or equivalent experience.

    Experience:

    • 4+ years of Clinical Research Associate (CRA) experience or equivalent preferred.
    • 2-4 years of Clinical Trial Manager (CTM) experience or an equivalent combination of education and experience.
    • Specific therapeutic experience (e.g., infectious disease, oncology) may be required.

    Skills/Competencies:

    • Strong written and verbal communication skills.
    • Analytical skills with the ability to set strategies and follow through.
    • Foster a collaborative exchange of information and ideas.
    • Strong interpersonal skills, maintaining relationships with internal and external customers.
    • Represents Caidya as a brand ambassador externally.
    • Expert monitoring skills for conducting site monitoring visits independently.
    • Exceptional computer skills and the ability to work across multiple technologies.
    • Strong presentation skills and comprehensive knowledge of GCP/ICH guidelines.
    • Proficient in medical terminology and able to exercise independent judgment.
    • Exceptional attention to detail and superior problem-solving skills.
    • Successful in a matrix environment and able to manage multiple vendors.
    • Management of global studies preferred.
    • Exceptional time management and organizational skills, with strong documentation skills.

    Capabilities:

    • Ability to work remotely as required.
    • Valid passport required for international business travel.
    • Willingness to travel 10% to 20% as needed.

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