Lead Clinical Data Manager

Katalyst-Healthcares-; United States; On-site; USD 130,000 - 180,000; Full time

Job summary

Fives DyAG Corp. is seeking a senior Clinical Data Management leader to drive oncology trials, ensuring timelines, budgets, and data quality. You will design data management plans, CRFs, and edit checks, and oversee Medidata Rave EDC configuration and validation across studies.

Collaboration with Biostatistics, Clinical Operations, Safety, and Regulatory is essential. Requires 7+ years in clinical data management, CCDM certification, CRO oversight experience, and strong project management skills

Qualifications

• Bachelor's degree in Life Sciences, Computer Science, or related field; advanced degree preferred.
• 7+ years of clinical data management experience in biotechnology or pharmaceutical industry.
• Experience managing oncology clinical trials data and related data requirements.
• CCDM certification or equivalent.
• Experience with CRO and vendor oversight.
• Strong project management and communication skills.
• Knowledge of FDA/ICH, GCP, CDISC standards.
• Experience with risk-based monitoring in oncology studies.
• Familiarity with emerging data collection technologies (ePRO, wearables, AI/ML).

Responsibilities

• Lead and manage clinical data management activities for oncology trials, ensuring timelines, budgets, and quality.
• Provide strategic oversight to CRO data management teams for assigned studies.
• Develop and implement data management plans, CRFs, edit checks, and data validation plans.
• Oversee design, build, and validation of Medidata Rave EDC databases.
• Review data for trends, inconsistencies, and issues impacting quality or outcomes.
• Collaborate with Biostatistics, Clinical Operations, Safety, and Regulatory.
• Provide oversight and performance management of external vendors.
• Maintain SOPs, guidelines, and best practices for data management.
• Represent the Data Management function in internal/external meetings and provide expert guidance.
• Stay current with industry trends, regulatory requirements, and oncology data management advancements.

Skills

Clinical data management

Project management

Vendor oversight

Regulatory knowledge

Analytical skills

Communication skills

SAS or R

Oncology trials

Data quality assessment

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Tools

SAS

R

Microsoft Office Suite

Medidata Rave

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.

Requirements

• 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).