Support the design, specifications, and development of eCRFs
Develop Data Management Plan documents
Manage effective communication of data issues and discrepancies to study sites via the query management process
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are committed to transforming the future of treatment for autoimmune disease and redefining what’s possible.
Provides validation and UAT support for Clinical Data Management activities across studies.
Leads and coordinates functions for multiple assigned projects related to the planning, execution, collection, and cleaning of clinical data.
Works within the company’s SOPs, guidelines and standards to ensure data integrity at all times.
Iovance Biotherapeutics is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, their employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.
Responsible for timelines and quality of CDM deliverables for the assigned studies.
Manages CDM timelines to coordinate and synchronize deliverables with the overall study timelines.
Responsible for the accuracy and completeness of the clinical data collected during a clinical trial.
Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies. They are committed to fair and equitable compensation practices and strive to provide employees with competitive total compensation packages.
Lead the end-to-end clinical data management strategy for Phase 3 and late-stage clinical trials.
Provide hands-on oversight of CROs and external data management vendors, ensuring delivery against timelines, quality, and budget.
Partner closely with Biostatistics to support interim analyses, database locks, and final clinical study reports.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, Braveheart Bio represents an outstanding opportunity for ambitious, mission-driven professionals to make a tangible impact in a high-profile and rapidly evolving therapeutic area.
Assist with case abstraction under the direction of a Team Leader
Complete assigned abstractions in a timely manner
Roles and responsibilities often evolve and adapt over time.
Layer Health was founded in 2023 by leading machine learning researchers from MIT and Harvard Medical School. They are building an AI layer to synthesize information from medical records and reduce friction in healthcare; their LLM-powered platform solves chart review. The diverse founding team brings expertise across machine learning, UI/UX, large language models, and medicine.
Monitor the progress of clinical studies at investigative sites, ensuring studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
Coordinate activities to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
Identify potential study risks and propose solutions on how to mitigate them.
Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences to improve therapies for patients, with a focus on Oncology and Rare Disease. They cultivate a culture, and have high CRA retention rates.
Partner with Territory Manager to demo products and close deals.
Implement product at customer site and train customer.
Own post-sales activities and encourage customer product adoption.
FUJIFILM Sonosite reinvents how healthcare is delivered with point-of-care ultrasound technology. As the leader in bedside ultrasound systems, their innovations save lives. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments.
Support the development and refinement of study documents under the guidance of senior clinical scientists.
Conduct routine clinical data reviews to ensure data quality, completeness, and medical plausibility.
Partner with clinical scientists, statisticians, and medical directors to extract and interpret scientific data for abstracts, posters, presentations, and manuscripts.
Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other.
Perform manual visual review of medical imaging studies using approved DICOM viewers.
Verify that no Protected Health Information (PHI) is present in imaging data prior to delivery.
Document review outcomes using Avandra QA workflows and tools.
Aegis Ventures partners with entrepreneurs and industry leaders to launch and scale transformative companies in digital health and artificial intelligence. With a focus on innovations in healthcare, Aegis has launched four successful portfolio companies in partnership with Northwell Health and recently announced the Digital Consortium to co-develop, invest in, and launch new companies.
Responsible for assisting in managing Epic in baskets including but not limited to results, orders, and patient messages.
Complete tasks within scope of certification, licensure and competency as delegated by provider to support patient care.
Provider appropriate and timely documentation in the patient’s electronic medical record using standardized workflows and processes
UnityPoint Health is committed to its team members and is recognized as a Top 150 Place to Work in Healthcare by Becker's Healthcare. They champion a culture of belonging where everyone feels valued and respected, honoring the ways people are unique and embracing what brings them together.
The Research Assistant (RA) will conduct approximately forty (40) 60-minute Zoom interviews with healthcare providers between late March and May.
Additional responsibilities include coordinating and sending participant e-gift cards, attending meetings, and organizing audio/transcripts.
The RA will serve as a qualitative coder alongside the PI to support codebook development, analytic triangulation, and intercoder agreement.
Emory University is a leading research university that fosters excellence by attracting world-class talent. They innovate today to prepare leaders for the future and welcome candidates who can contribute to our academic community.
Provide leadership for the Data Management group and ensure quality data.
Oversee DM vendors' deliverables and maintain strong collaboration.
Create procedures for data collection, review, and cleaning processes.
Definium Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for brain health disorders. They aim to be a global leader in delivering innovative treatments to improve patient outcomes and are expanding their global presence.
Accountable for study level tracking as assigned by the Clinical Project Manager.
Ensures patient enrollment activities are conducted in a timely manner and is comfortable communicating with site personnel.
Acts as QC of Trial Master Files; creates, maintains, and closes out TMFs; is key in set up, conduct, and close out of ancillary services.
Akero Therapeutics, a Novo Nordisk company, is focused on discovering and developing transformational treatments for patients with serious metabolic diseases. They are a team of problem solvers dedicated to pursuing bold scientific approaches to build a brighter future for patients.
Own the day-to-day tracking and progress of clinician credentialing and payer enrollment workflows.
Identify and resolve blockers across credentialing, enrollment, and re-credentialing processes.
Support clinicians directly by guiding them through credentialing and enrollment requirements.
Wheel is evolving the traditional care ecosystem by equipping companies with a premier platform to deliver virtual care at scale. They offer strategies and technologies to foster consumer engagement, build brand loyalty, and maximize return on investment.
Assist with investigator recruitment activities and site feasibility tasks.
Perform essential document collection, review, and maintenance activities.
Act as site contact for study and site management issues.
Precision for Medicine supports life sciences companies in the use of precision medicine by helping them design and execute clinical trials. They focus on biomarker-led strategies and have expertise in data science, clinical trial management, and laboratory services.
Support large, complex customer implementations through the end-to-end implementation process.
Assist with the delivery of the solution, ensuring that each project is executed seamlessly within the scope, timelines, and contractual requirements.
Serve as an additional point of contact for customers and internal stakeholders, managing communications, addressing challenges, and ensuring that milestones are met successfully.
Turquoise Health is making healthcare pricing simpler, more transparent, and lower cost for everyone. They are a Series B startup backed by top VCs a16z, Box Group, Bessemer Venture Partners, Tiger Global, Adams Street, and Yosemite, with an accomplished group of folks with a passion for improving healthcare.