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Sr. Manager/Associate Director, Clinical Data Management

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 Senior Manager / Associate Director, Clinical Data Management who will be responsible for the management and oversight of clinical data management activities for an entire clinical program, consisting of multiple clinical trials. This individual will work closely with clinical study teams and external vendor partners to ensure the timely and successful delivery of high-quality data generated from clinical trials. This position will report to the head of Clinical Data Management and will closely interact with several key functional areas that support the clinical research programs at IGM. These potentially include, but may not necessarily be limited to Clinical Operations, Clinical Science/Clinical Development, Biometrics, Safety/Pharmacovigilance, Clinical Biomarkers, Clinical Pharmacology, Clinical Quality Assurance, Program Management, Medical Writing, and Regulatory.Responsibilities:• Responsible for all clinical data management activities for assigned clinical programs, from study start up through study closeout• Ensures the collection and handling of clinical data to the highest quality standards• Oversees all data management and clinical data programming support activities for clinical trials for timely and accurate data acquisition, integration, analysis, and interpretation of results• Responsible for clinical data management vendor oversight and management for outsourced clinical trials• Oversees the development and maintenance of electronic data capture (EDC) systems• Maintains inspection readiness state of clinical data management activities as appropriate• Ensures appropriate clinical data management documentation are maintained in the electronic Trial Master File (eTMF)• Assesses the overall quality of data and identifies key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns, e.g., increased frequency of queries, protocol deviations, and early treatment discontinuations• Identifies and assesses risks in data collection and management and ensures the existence of mitigation plans to address any significant risks• Ensures compliance with regulations, established standards, and industry best practices• Leads and participates in the development and implementation of SOPs, templates, and processes, and other departmental and/or cross-functional initiatives• Mentors and may supervise multidisciplinary clinical data management team membersQualifications:Minimum 10 years of pharmaceutical, biotech, or CRO industry experience and a proven track record of successfully managing and overseeing multiple clinical trials, either directly or through third-party service providers• Bachelor’s degree in mathematics, science, or related field• Experience with auto-immune and oncology trials in the early and late stages of drug development is highly preferred• Extensive knowledge of EDC systems, especially Medidata Rave• Solid understanding of iMedidata and Medidata Cloud Administration preferred• Extensive experience with other clinical trial systems, including but not limited to IRT, eTMF, CTMS• Strong knowledge of CDISC standards, with emphasis on CDASH, SDTM/SDTMIG• Extensive knowledge of all international regulations pertaining to the conduct of clinical trials, including Good Clinical Practice (GCP), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) guidelines, and the expectations of regulatory bodies such as the FDA, EMA, and MHRA in this important area• Extensive experience working with and managing external vendors and Contract Research Organizations (CROs) involved in supporting clinical research programs related to data management activities• High organizational ability; detail-oriented; able to coordinate multiple projects in a matrixed team environment• Capable of strategic planning to ensure key issues are vetted for long term success including alternatives, considering available resources in a small growing company and company values.• Superior skills in partnership building, both internal and external, and keeping focus on company priorities, metrics and shared accountability.• Being able to adapt and being effective at times of change, and adjusting and seeing the benefits of new ways of solving data management issues.• Excellent verbal and written communication skills• Energetic, hands-on professional approachThe typical annual salary range for this full-time position is $135,000 - $195,000, 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 applicant's geographic location. Actual individual pay is determined by demonstrated experience and internal equity alignment.\n\nWe offer a fast-paced, collaborative, team-based, and family-like work environment.One of our top priorities is to maintain the health and wellbeing 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 optionsIGM 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
15 days ago

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