Lead Clinical Data Manager

Katalyst CRO; Boston (MA); Sur place; USD 130 000 - 170 000; Plein temps

Résumé du poste

Katalyst CRO is seeking a Lead Clinical Data Manager to lead oncology data management across trials, ensuring timelines, budgets, and data quality are met. You will direct CRO teams, craft data management plans, and oversee Medidata Rave EDC implementations.

You will also review data for quality, collaborate with Biostatistics, Safety and Regulatory, and stay current with evolving CDISC standards and risk-based monitoring practices.

Qualifications

• 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 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).

Responsabilités

• 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.

Connaissances

Data management leadership

Strategic oversight

CRF & DMP design

Medidata Rave EDC

Regulatory knowledge (FDA/ICH/CDISC)

CRO/vendor oversight

Project management

Analytical thinking

Communication skills

MS Office

SAS

R

CDM certification (CCDM)

Risk-based monitoring

Oncology data expertise

Emerging tech in data collection

Formation

Bachelor's degree in Life Sciences, Computer Science, or related field

Advanced degree preferred

Outils

Medidata Rave

SAS

R

Description du poste

• 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).