Clinical Trial Associate
Mountain View, CA /
Clinical Research & Development – Development Operations /
About IGM Biosciences, Inc.
IGM Biosciences (Nasdaq: IGMS) is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer, infectious diseases, and autoimmune and inflammatory diseases. The Company’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites compared to conventional IgG antibodies with only 2 binding sites. We have created a proprietary IgM antibody technology platform that we believe is particularly well suited for developing T cell engagers, receptor cross-linking agonists, targeted cytokines, and target neutralizers. The Company also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology and immunology, and inflammation targets. For more information, please visit www.igmbio.com.
IgM Antibodies and Autoimmune and Inflammatory Diseases
Antibody treatments have revolutionized outcomes for patients with autoimmune and inflammatory diseases, and IgMs are the first antibody defense against a pathogen infection. We are committed to exploring how the unique structure and binding properties of our IgM platform can improve outcomes for patients with these serious conditions.
IgM Antibodies and Oncology
IGM Biosciences has a T cell engager program, a receptor cross-linking agonist program and a targeted cytokine program in clinical studies for the treatment of patients with solid tumors and hematological malignancies.
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 the maintenance and management of TMF and study documents including informed consent forms, and SOPs.
- Supports the clinical team regarding the 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 the training of new users on eTMF, related SOPs, and systems access.
- As directed, arranges and participates in meetings including 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.
- Associate’s degree/Bachelor's degree or higher is preferred
- Minimum of 2 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 Projects, 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
The typical annual salary range for this full-time position is $75,000 - $111,000, plus eligibility for cash and equity incentives.
This range reflects the characteristics of the job, such as required skills and qualifications, and is based on the office location noted in this job posting. The range may also be adjusted based on the applicant's geographic location.
Actual individual pay is determined by demonstrated experience and internal equity alignment.
We offer a fast-paced, collaborative, team-based, work environment.
One of our top priorities is to maintain the health and well-being of our employees and their families. To achieve this goal, we offer comprehensive benefits with a variety of options:
· Medical, dental and vision insurance.
· The full premium amount for our employees and their dependents is covered by IGM
· FSA (Flexible Spending Account)
· 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, 11 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.