Who We Are
Bolt Biotherapeutics, based in the San Francisco Bay Area, is a clinical-stage biotechnology company developing Boltbody™ Immune-stimulating Antibody Conjugates (ISACs), a new class of immuno-oncology therapeutics. This is a unique opportunity to join and build, with like-minded colleagues, a company that will transform the lives of individuals with cancer.
The Position
Reporting to the Head of Clinical Operations, the Director, Clinical Data Management (CDM), will be responsible for overseeing & supporting clinical data management activities for assigned projects in accordance with ICH/Good Clinical Practices (GCP), GCDMP and other relevant guidelines.The CDM will oversee data management processes and CRO performance to ensure study deliverables and timelines are met. They will also ensure the quality of clinical data to meet standards for regulatory submission, publications, and other high-profile business activities.The role will lead/support eCRF design & EDC validation, set up & validate vendor data transfer (e.g., PK, biomarker), lead/support data cleaning activities, generate and/or review & approve study-specific Data Management documents, generate and/or distribute data management metrics, data listings and status reports.
Key Responsibilities
• Works collaboratively with relevant Bolt functions (e.g., Clinical Operations, Biometrics, Clinical Development, Drug Safety, Regulatory Affairs, Project Management), and with CRO and other trial vendors, to meet clinical data management deliverables consistent with clinical trial timelines.• Responsible for eCRF design, development, validation, and maintenance of clinical study databases for clinical trials• Monitors Data Management processes and CRO performance• Performs/oversees data review and cleaning activities, including EDC reconciliation with all external datasets (e.g., safety, biomarkers, IRT, central imaging), and assure quality interim and final reporting of clinical data• Generates and/or review/approve study documents (e.g., Data Management Plans, data transfer specifications, SAE and/or external (e.g., biomarker) data reconciliation plans, coding conventions, study protocols)• Ensures the quality of clinical data to meet standards for regulatory submissions.
Generate and/or implement the Data Quality Review Plan (DQRP) defining and documenting the data quality, review strategy for each clinical trial in collaboration with cross-functional team, enabling the ongoing quality review of patient data supporting regulatory filings, publications, and other high-profile business activities •Generates and/or distributes data management metrics, data listings and status reports• Contributes to the ongoing development, review, and revisions of Clinical Data Management Standard Operating Procedures (SOPs) and standard CDM templates• Collaborate cross-functionally to resolve or escalate data management issues, and ensure effective communication throughout all clinical trial phases• Knowledge of FDA regulations and industry best practices (e.g., GCP, 21 CFR Part 11, ISO 14155)• Performs miscellaneous job-related duties as assigned
Job Requirements
• B.S. /B.A. in a science or technical discipline degree with 10 years of experience in clinical data management, or M.S in a science or technical discipline degree with 8 years of experience in clinical data management• Expertise with multiple EDC platforms, including Medidata RAVE.• Demonstrated success managing Clinical Data Management within an outsourced data management model, including the generation of biosample analysis datasets• Experience working in an FDA regulated environment• Solution-oriented mindset with excellent attention to detail• Open to continuous improvement• Exceptional spoken and written communication ability• Highly collaborative$190,000 - $250,000 a yearWe are an Equal Opportunity Employer offering a competitive salary and benefits package.
Applicants should be legally entitled to work for any employer in the US. Bolt Biotherapeutics requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Bolt will consider requests for Reasonable Accommodations.Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.Apply for this job
