Katalyst CRO ยท 3 months ago
Lead Clinical Data Manager
Albany, NY
Contract
Onsite
Senior Level, Lead/Staff
7+ years expKatalyst CRO is seeking a Lead Clinical Data Manager to oversee clinical data management activities for oncology clinical trials. The role involves managing data management teams, developing data management plans, and ensuring compliance with regulatory requirements while collaborating with cross-functional teams.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Qualification
Required
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)
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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