Jobs
>
Boston

    Senior Clinical Trial Manager - Boston, United States - Argenx

    Argenx
    Argenx Boston, United States

    1 week ago

    Default job background
    Description
    PURPOSE OF THE FUNCTION

    The Senior Clinical Trial Manager (CTM) is responsible for all operational aspects of the assigned clinical studies from monitoring initiation till closure of the studies. The successful candidate will have clinical trial operational experience in phase I, II and III drug development phases and is an operational expert in the clinical trial activities from start-up, execution until closure and its underlying activities. The Sr. CTM will be the "operational clinical trial voice" for the assigned studies, both internally and externally, he or she is owning the timelines of a clinical trial project and is accountable to keep the trial on track. The Senior Clinical Trial Manager will work with little to no supervision or direction and have the ability to coach junior team members and act as a right hand to the CODL (Clinical Operations Development Lead). The successful candidate will excel in establishing good and effective internal and external working relationships.

    REPORTING LINE

    The Sr. CTM reports to the Clinical Operations Development Lead (CODL)

    ROLES AND RESPONSIBILITIES

    The Sr. CTM is responsible for all clinical operational aspects for the assigned global clinical trial(s) from preparation until closure. The trial responsibilities include:
    • Participate and lead the clinical trial team meetings together with the Lead Trial Physician
    • Oversee risk identification and mitigations for the clinical trials, provide solutions and oversee implementation
    • Oversee all trial related aspects, timelines, budget and quality. Close collaboration with the CODL on changes, issues and potential solutions
    • Ensure that clinical trials are executed according to the Clinical Development Plan (CDP), trial plans, OGSM and in compliance with argenx procedures, ICH-GCP and other applicable legislations
    • Support and participate in CRO and vendor selection
    • Lead CRO contracts negotiations together with the argenx vendor manager
    • Responsible for leading, guiding and overseeing the CROs and other (lab) vendors involved in the assigned clinical trial based upon metrics and plan
    • Member of the Country and Site Selection Commission for the specific trial
    • Provide input into and/or develop trial related materials such as clinical protocol, clinical monitoring plans, data management plan, eCRF and completion guidelines, patient information and informed consent, site instructions for specimen collections, patient retention and recruitment materials
    • Oversee and track patient recruitment and pro-actively identifies ways to prevent recruitment delays
    • Develop monitoring and site oversight strategy and oversee adherence to it. Perform site oversight visits according to plan
    • Review monitoring visit reports, protocol deviations and data listings to ensure reliable quality data are delivered and proactively identify and solve issues/concerns
    • Monitor data quality
    • Ensure that the Trial Master File (TMF) is maintained and up to date
    • Ensure timely availability of investigational product supply on site and ensure clinical site accountability records on site are in place and maintained
    • Ensure timely collection, documentation and reporting of Adverse events (AEs) and Serious AEs (SAEs) and collaborate in submission of the reports to FDA, EMEA and other applicable regulatory authorities
    • Ensure supportive relationships with clinical sites and trial personnel
    • Clearly communicate on goals/expectations and motivate team members, including vendors, to work towards achieving clinical trial goals
    • Pro-actively identify and solve issues in the assigned clinical trial and timely escalate them to CODL, Head of Trial Operations and/or Senior Management, as needed
    • Responsible and contact person during inspections/audits for the assigned trial together with the Quality Assurance representative
    • Identify efficiencies, best practices and lessons learnt. Search for and embrace innovation
    Note: for trials where more than 1 CTM is identified, the tasks will be divided, and so not all CTMs might be involved in all the tasks as listed above.

    The Sr. CTM will also participate in activities other than trial-related which include but are not limited to:
    • Provide input to the clinical development strategy/plan
    • Provide input to procedures/SOPs/WIs and related documents
    • Participate in workstreams
    • Ensure best practices and lessons learnt are shared across trials/indications/compounds
    • Coaching and mentoring other team members
    SKILLS AND COMPETENCIES
    • Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical trial
    • Experience with tools and systems for managing clinical studies (MS project, trial progress and metric systems, eCRF databases)
    EDUCATION, EXPERIENCE AND QUALIFICATIONS
    • Bachelor's degree or University degree - medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience
    • Minimum of 6-7 years of experience in Clinical Operations and managing CROs and vendors
    • Biotech experience is a plus
    • Auto-immune and/or oncology clinical trial background is a plus
    At argenx we strive to create a welcoming and inclusive environment. Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.

    If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at Only inquiries related to an accommodation request will receive a response.
  • Beacon Hill

    Clinical Trial Manager

    6 days ago

    Beacon Hill Boston, United States

    Position Overview: Reporting to the Director of Clinical Operations, this individual will have primary responsibility for trial management for a first-in-human trial in both healthy volunteers and patients. This person will manage cross-functional relationships with internal and ...

  • Life Science People

    Clinical Trial Manager

    2 weeks ago

    Life Science People Boston, United States

    Our client is a leading biotechnology company dedicated to advancing innovative therapies in the fields of oncology, transplantation, and cellular therapy. We are committed to improving patient outcomes and transforming the landscape of medical care through groundbreaking researc ...

  • Imbria Pharmaceuticals

    Clinical Trial Manager

    4 days ago

    Imbria Pharmaceuticals Boston, United States

    Company Overview · Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell's ability to produce energy in cardiova ...

  • Fusion Pharmaceuticals LLC

    Senior Clinical Trial Manager/Clinical Trial Manager

    3 days ago

    Fusion Pharmaceuticals LLC Cambridge, United States

    Fusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting ...

  • Stratacuity

    Clinical Trial Manager

    1 week ago

    Stratacuity Cambridge, United States

    Clinical Trial Manager Location: Cambridge, MA (Hybrid) Science: Antibody Drug Conjugates Therapeutic Area: Oncology Job Overview: This role is an exciting opportunity for a motivated individual to strategically guide the operationalization of our client's clinical strategy, ment ...

  • Fusion Pharmaceuticals LLC

    Senior Clinical Trial Manager/Clinical Trial Manager

    1 week ago

    Fusion Pharmaceuticals LLC Everett, United States

    Fusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting ...

  • Stratacuity

    Clinical Trial Manager

    1 week ago

    Stratacuity Cambridge, United States

    Location: Cambridge, MA (Hybrid) · Science: Antibody Drug Conjugates · Therapeutic Area: Oncology · Job Overview: This role is an exciting opportunity for a motivated individual to strategically guide the operationalization of our clients clinical strategy, mentor colleagues, ...

  • Fusion Pharmaceuticals

    Senior Clinical Trial Manager

    6 days ago

    Fusion Pharmaceuticals Boston, United States

    Fusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting ...

  • ProClinical

    Sr. Clinical Trial Manager

    15 hours ago

    ProClinical Boston, MA, United States

    Proclinical is seeking a dedicated Senior Clinical Trial Manager (CTM) to join our global Clinical Operations Department. The successful candidate will play a crucial role in managing and executing clinical trials, ensuring compliance with regulations, maintaining timelines, and ...

  • Bicycle Therapeutics

    Senior Clinical Trial Manager

    1 week ago

    Bicycle Therapeutics Cambridge, United States

    Company Description · Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell agonists and Bicycle tumor-targete ...

  • Vor Biopharma Inc.

    Senior Clinical Trial Manager

    1 week ago

    Vor Biopharma Inc. Cambridge, United States

    Who we are looking for: · Vor Bio is seeking a Senior Clinical Trial Manager to join our dynamic Clinical Operations team. The Senior Clinical Trial Manager (Sr CTM) is a motivated, independent, organized individual who will be responsible for the successful execution of clinical ...

  • Clinical Dynamix, Inc.

    senior clinical trials manager

    1 week ago

    Clinical Dynamix, Inc. Cambridge, MA, United States

    Role: Clinical Trial Manager / Senior Clinical Trial Manager · We are looking for a energetic and passionate Clinical Trial Manager / Senior Clinical Trial Manager who is excited to plan and lead timely and high quality oncology clinical trial execution. The ideal candidate has a ...

  • Boston Pharmaceuticals

    Senior Clinical Trial Manager

    5 days ago

    Boston Pharmaceuticals Cambridge, United States

    Company Overview · Boston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being ...

  • Prime Medicine, Inc.

    Senior Clinical Trial Manager

    6 days ago

    Prime Medicine, Inc. Cambridge, United States

    Company Overview: · Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing ...

  • Vertex Pharmaceuticals

    Director, Clinical Trial Management

    1 week ago

    Vertex Pharmaceuticals Boston, MA, United States

    Apply locations Boston, MA time type Full time posted on Posted 2 Days Ago job requisition id REQ-21950 Job Description · Location: Boston, MA (3 days onsite, 2 days remote weekly) · Vertex currently operates at the forefront of rare disease scientific innovation and has success ...

  • Prime Medicine

    Senior Clinical Trial Manager

    2 weeks ago

    Prime Medicine Cambridge, United States

    Company Overview:Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing tec ...

  • Bicycle Therapeutics

    Senior Clinical Trial Manager

    4 days ago

    Bicycle Therapeutics Cambridge, United States

    Job Description · Job DescriptionCompany Description · Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell a ...

  • BlueRock Therapeutics

    Associate Director, Clinical Trial Manager

    1 week ago

    BlueRock Therapeutics Cambridge, United States

    This position will lead a cross-functional clinical development team to ensure the successful planning, execution, and close-out of an upcoming Phase 1/2a clinical study and other studies, as needed. This individual will manage and oversee internal and external study activities, ...

  • Alkermes

    Clinical Trial Manager

    2 weeks ago

    Alkermes Watertown, United States

    Job Description · Position Summary: Responsible for oversight, coordination, and execution of clinical trials in support of clinical programs in Phases I-IV of development. · ResponsibilitiesClinical project team member: works closely with the Sr. CTM and/or Clinical Program Man ...

  • BlueRock Therapeutics

    Associate Director, Clinical Trial Manager

    2 weeks ago

    BlueRock Therapeutics Cambridge, United States

    Who is BlueRock?BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation o ...