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Senior Clinical Trial Associate

IGM Biosciences (Nasdaq: IGMS) is a clinical-stage biotechnology company pioneering the development of engineered IgM antibodies for the treatment of cancer, infectious diseases, and autoimmune and inflammatory diseases. IgM antibodies have inherent properties that we believe may enable them to bind more strongly to targets on the surface of cells than comparable IgG antibodies. We believe our proprietary IgM antibody technology platform is particularly well suited for developing T cell engagers, receptor cross-linking agonists, targeted cytokines, and target neutralizers. Our lead product candidate, Imvotamab, is a bispecific T cell engaging IgM antibody targeting CD20 and CD3 proteins, and it is currently in two Phase 2 clinical trials for the treatment of relapsed and/or refractory diffuse large B cell lymphoma and follicular lymphoma. Our second product candidate is IGM-8444, an IgM antibody targeting Death Receptor 5 (DR5) for the treatment of patients with relapsed and/or refractory solid and hematologic malignancies, and it is currently in a Phase 1 clinical trial. Also in our product pipeline is IGM-7354 and IGM-2644. IGM-7354 is an anti-PD-L1 IgM antibody that targets the delivery of interleukin-15 (IL-15) cytokines to the area of PD-L1 expressing cells for the treatment of patients with solid and hematologic malignancies. IGM-2644 is a bispecific T cell engaging IgM antibody targeting CD38 and CD3 proteins for the treatment of patients with multiple myeloma.We are seeking an experienced Sr. Clinical Trial Associate to successfully support one or more clinical trials/programs with minimal supervision, starting from First in Human Phase I studies, primarily in autoimmunity indications. Must be able to support all clinical operational aspects of a clinical trial/program from start-up, site selection, enrollment, maintenance, and close-out. Must be attentive to detail and able to contribute to maintenance and management of TMF and study documents to include informed consent forms, SOPs, etc.Responsibilities:· Supports the clinical team regarding preparation of essential clinical trial documentation, ensuring distribution, tracking and filing of documents as applicable.· Assists with management and maintenance of eTMF or other program/study related files in accordance with GCP.· Coordinates management and maintenance of study documents· Coordinates archiving of study documents as directed by operations trial leads.· QCs study documents as needed· Organizes presentations for Investigator Meetings· Participates in the development of protocols and Case Report Forms as assigned· Participates in writing clinical trial reports as assigned· May support training of new users on eTMF, related SOPs, and systems access.· As directed, arranges and participates in meetings to include preparation and distribution of agendas and meeting materials, and taking/distributing meeting minutes.· Assists with the review, tracking and processing of payments/invoices related to investigators, consultants and service providers.· Performs administrative duties in support of clinical trials,· Performs additional tasks as required to support Clinical Trial managers.Qualifications:· Associate’s degree/Bachelors degree or higher is preferred· Minimum of 3 years of clinical trial administration experience in the pharmaceutical/biotechnology/CRO industry Knowledge of drug development and FDA GCP/ICH regulatory guidelines· Knowledge of essential documents for investigator files and TMF· Familiar with Informed Consent Forms, Electronic Data Capture, IRT· Attention to detail, accuracy and strong follow through on work· Effective time management and organizational skills· Good analytical and problem-solving skills· Strong communication skills, both oral and written· Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook), MS Project and Adobe Acrobat· Proficiency with set-up and technical support of remote meetings using MS Teams, WebEx (or similar systems)· May be required to travel to support clinical operations objectives\n\nOne of our top priorities is to maintain the health and wellbeing of our employees and their families. To achieve this goal, we are offering robust and comprehensive benefits with a variety of options:· Medical, dental, and vision insurance. The full premium amount for our employees and their dependents is currently covered by IGM· STD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance· 401(k) Plan· 120 hours of Paid Time Off, 5 sick days per year, 10 holidays· Cell phone & internet subsidy· Employee Referral Bonus Program· Annual training budget for professional development· Commuter Benefit· Annual bonus program· New hire stock options IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. All qualified applicants will receive consideration for employment.

Job Type
Full Time
Salary
N/A
Experience
N/A
Posted
13 days ago

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