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    Senior Clinical Trial Manager

    Genmab
    3-7 years
    Not Disclosed
    Princeton Junction
    15 June 10, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

    Senior Clinical Trial Manager

    Location: Genmab

    Summary:

    Genmab is dedicated to building extraordinary futures by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment. We are seeking a Senior Clinical Trial Manager who excels in delivering key trial management elements for oncology trials and ensuring sponsor engagement. Join our innovative, hardworking, and ambitious team to improve the lives of cancer patients.

    Responsibilities:

    Trial Planning and Documentation:

    • Develop operational plans, manuals, and charters for the trial.
    • Review protocol and protocol amendments and other trial documents as necessary.
    • Create and coordinate the writing of the Investigational Medicinal Product (IMP) Plan.
    • Coordinate the development of the Trial Oversight Plan.
    • Review the Clinical Trial Application (CTA) submission package.
    • Review site regulatory documents.
    • Develop Global Master ICF.
    • Coordinate the resolution of site or monitoring issues with CROs or other applicable vendors.

    Site Selection and Management:

    • Drive site selection in collaboration with the Start-up team.
    • Review and approve SSV summaries.
    • Coordinate the review of CRO country-specific informed consent forms (ICFs) with internal stakeholders.
    • Coordinate translation/back-translation process of ICFs.

    Vendor Management and Oversight:

    • Oversee vendor management across vendors (excluding budget/change orders).
    • Approve key CRO staff (e.g., Clinical leads or Trial-specific CRA).

    Trial Execution and Monitoring:

    • Conduct initial Protocol Deviation (PD) assessments and track trends.
    • Ensure the ongoing completeness of the electronic Trial Master File (eTMF).
    • Keep the Trial Management Dashboard (TMD) and portfolio app in GenSense up to date.
    • Drive the ODB review meeting.
    • Participate in RBQM activities.
    • Assist in maintaining the CTT issue log in collaboration with GCTM.
    • Collaborate or manage study escalations both internally and externally.
    • Support GCTM to assess KPI/KQI at the trial level.
    • Support QA in site audit activities and vendor audits.
    • Conduct booster visits.
    • Participate in inspection readiness activities.
    • Oversee and collaborate with CTT members/vendors/assigned functional representatives on tracking and reconciliation of trial-related items such as scans and blood samples.

    Key Competencies:

    • Understanding of trial execution, including knowledge of the processes, procedures, and principles involved in conducting clinical trials.
    • Experience in clinical drug development and GCP.
    • Role model the Genmab ONE team spirit.
    • Excellent written and oral English communication skills.
    • Ability to proactively identify risks, develop mitigations, and resolve issues.
    • Strong stakeholder management skills.
    • Experience operating in a global setting.

    Requirements:

    • BSc or MSc degree in medical, biological, pharmaceutical science, or equivalent.
    • Minimum 5 years of experience in clinical trial management from a pharmaceutical company and/or CRO.
    • Experience in oncology and/or first-in-human trials is preferred.
    • Proven skills in working in a project-oriented and international organization.
    • Excellent communication skills in English, both written and spoken.

    Personal Attributes:

    • Dedicated team player who enjoys leading teams and inspiring trust among colleagues.
    • Quality mindset and able to prioritize work in a fast-paced and changing environment.
    • Result- and goal-oriented and committed to contributing to the overall success of Genmab.

    Compensation:

    For US-based candidates, the proposed salary band for this position is $114,375.00 to $190,625.00. The actual salary offer will consider a wide range of factors, including skills, qualifications, experience, and location. Certain positions are eligible for additional forms of compensation, such as bonuses.

    About Genmab:

    Genmab is an international biotechnology company with a core purpose of improving the lives of patients through innovative and differentiated antibody therapeutics. Founded in 1999, Genmab is headquartered in Copenhagen, Denmark, with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S., and Tokyo, Japan. Our team is passionate, innovative, and collaborative, inventing next-generation antibody technology platforms and leveraging translational research and data sciences.

    Commitment to Diversity, Equity, and Inclusion:

    We are committed to fostering workplace diversity at all levels and believe it is essential for our continued success. No applicant shall be discriminated against based on race, color, religion, sex, national origin, age, disability, or genetic information.

    Privacy Policy:

    Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application.

    Application Information for Netherlands:

    For positions in the Netherlands, Genmab offers a fixed-term employment contract for a year initially, with the possibility of renewal for an indefinite term based on performance and business conditions.

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