Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
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Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. * Provide strategic oversight and direction ...
Tempus Jobs Information
What is it like to work at Tempus?
Tempus is a data-driven healthcare technology company that prioritizes innovation and collaboration, fostering a culture of teamwork and continuous learning.
The company's structure is designed to facilitate interdisciplinary collaboration, with teams comprising experts from various fields, including medicine, engineering, and data science, working together to develop and implement cutting-edge technologies that improve cancer care and patient outcomes.
Working at Tempus may appeal to individuals who are passionate about using data and technology to drive meaningful change in healthcare, as the company offers opportunities for professional growth, a dynamic work environment, and the chance to contribute to a mission that has the potential to impact millions of lives.
The company's structure is designed to facilitate interdisciplinary collaboration, with teams comprising experts from various fields, including medicine, engineering, and data science, working together to develop and implement cutting-edge technologies that improve cancer care and patient outcomes.
Working at Tempus may appeal to individuals who are passionate about using data and technology to drive meaningful change in healthcare, as the company offers opportunities for professional growth, a dynamic work environment, and the chance to contribute to a mission that has the potential to impact millions of lives.
What makes Tempus an attractive place to work?
Tempus is a leading healthcare technology company that leverages artificial intelligence to revolutionize cancer care and improve patient outcomes. The company's workplace is characterized by a culture of innovation, collaboration, and teamwork, with opportunities for employees to work on cutting-edge projects and contribute to groundbreaking research. By joining Tempus, individuals can pursue a career that combines technical expertise with a passion for improving healthcare, with opportunities for professional growth, skill development, and making a meaningful impact in the lives of patients.
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Full-time
Re-posted 22 days ago
Job description
Responsibilities:
- Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards.
- Provide strategic oversight and direction to CRO clinical data management teams for assigned studies.
- Develop and implement data management plans, case report forms (CRFs), edit checks, and data validation plans in alignment with study protocols and regulatory requirements.
- Oversee the design, build, and validation of clinical databases using Medidata Rave EDC, ensuring optimal configuration and functionality.
- Conduct thorough reviews of clinical data, identifying trends, inconsistencies, and potential issues that may impact data quality or study outcomes.
- Collaborate with cross-functional teams including Biostatistics, Clinical Operations, Safety, and Regulatory to ensure alignment of data management strategies with overall clinical development goals.
- Provide oversight, and performance management of external data management vendors.
- Maintain SOPs, guidelines, and best practices for clinical data management processes.
- Represent the Clinical Data Management function in internal and external meetings, providing expert guidance on data-related matters.
- Stay current with industry trends, regulatory requirements, and technological advancements in clinical data management, particularly in the oncology field.
- Bachelor's degree in Life Sciences, Computer Science, or a related field; advanced degree preferred.
- A minimum of 7+ years of clinical data management experience in the biotechnology or pharmaceutical industry.
- Experience managing oncology clinical trials data, including a deep understanding of oncology-specific data requirements and challenges.
- Expert-level proficiency with Medidata Rave EDC, including system configuration, form design, and edit check programming.
- Strong knowledge of clinical research processes, FDA & ICH guidelines, GCP, GCDMP, and CDISC standards.
- Demonstrated experience in CRO and vendor oversight.
- Excellent project management skills with the ability to manage multiple studies simultaneously.
- Strong analytical and problem-solving skills with meticulous attention to detail.
- Outstanding communication and interpersonal skills, with the ability to effectively collaborate with diverse stakeholders.
- Proficiency in Microsoft Office Suite and familiarity with statistical software (e.g., SAS, R) is a plus.
- CCDM (Certified Clinical Data Manager) certification
- Experience with risk-based monitoring in oncology studies
- Knowledge of emerging technologies in clinical data collection and management (e.g., ePRO, wearables, AI/ML applications)
About Katalyst Healthcares & Life Sciences
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Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.
Industry
Scientific research and development services
Company size
51 - 200 Employees
Headquarters location
South Plainfield, NJ, US