Clinical Data Manager

Katalyst CRO; Princeton (NJ); Presencial; USD 120.000 - 160.000; Jornada completa

Descripción de la vacante

Katalyst CRO in Princeton, NJ is seeking a hands-on Clinical Data Manager to lead data management activities across multiple complex studies from startup through database lock and final reporting. The role requires strong leadership, project management, and deep knowledge of data standards.

You will design and oversee EDC implementations (Medidata Rave, Medrio), ensure data quality, coordinate with clinical operations, biostatistics, regulatory teams, and mentor junior staff while improving

Formación

• Bachelor's or Master's degree in life sciences, health informatics, computer science, or related field.
• Strong data structure and data systems understanding.
• Minimum 5+ years in clinical data management across studies.
• Proficiency with EDC systems such as Medidata Rave or Medrio.
• Knowledge of CDISC standards (CDASH, SDTM, ADaM) and coding (WHO Drug, MedDRA).
• GCP and regulatory knowledge (FDA/EMA) and data reporting familiarity.
• Leadership, project management, and ability to juggle multiple priorities.
• Excellent communication and cross-functional collaboration.
• CCDM or similar certification preferred.

Responsabilidades

• Lead clinical data management activities from startup to database lock and final reporting.
• Develop and manage data management timelines for multiple projects.
• Design, build, and oversee EDC databases using Medidata, Medrio, or similar.
• Maintain all data management documentation for clinical studies.
• Ensure accurate data capture with validation checks and edit checks.
• Oversee data validation, cleaning, discrepancy management, and query resolution.
• Ensure data accuracy, completeness, and regulatory compliance (FDA/EMA, CDISC).
• Prepare regulatory submissions and support data auditing processes.
• Collaborate with clinical operations, biostatistics, medical writing, and regulatory teams.
• Serve as primary contact for data management vendors and external partners.

Conocimientos

Leadership

Project management

Communication skills

Clinical data management

EDC systems proficiency

Educación

Bachelor's or Master's in life sciences/related

CCDM certification

Herramientas

Medidata Rave

Medrio

Descripción del empleo

Responsibilities

• Lead clinical data management activities for multiple complex studies, from study startup to database lock and final reporting.
• Develop and manage data management timelines for multiple projects, ensuring all milestones are met according to project plans.
• Design, build, and oversee the implementation and management of clinical trial databases using Electronic Data Capture (EDC) systems (e.g., Medidata, Medrio, or similar).
• Develop and oversee maintenance all data management documentation for all clinical studies.
• Ensure clinical data is captured accurately and efficiently, incorporating appropriate data validation checks and edit checks.
• Oversee data validation processes, including data cleaning, discrepancy management, and query resolution.
• Ensure data accuracy, completeness, and compliance with regulatory requirements (e.g., FDA, EMA) and industry standards (CDISC, SDTM, WHO Drug, MedDRA).
• Perform data review and provide feedback to study teams to improve data quality and resolve issues early in the trial process.
• Ensure clinical data management activities are compliant with regulatory requirements (FDA, EMA), ICH GCP guidelines, and other relevant regulations.
• Prepare and contribute to regulatory submissions, including clinical study reports, and support data auditing processes.
• Collaborate with clinical operations, biostatistics, statistical programming, medical writing, scientific and regulatory teams to provide data management expertise in clinical trial planning and execution.
• Serve as the primary point of contact for data management vendors and external partners, ensuring effective communication and timely issue resolution.
• Manage independent vendor and CRO biostatistical services performance and oversee compliance with contracts while ensuring budgetary efficiency
• Develop, implement, and continuously improve clinical data management processes and systems.
• Lead initiatives to enhance the efficiency and effectiveness of clinical data management, including the evaluation of new tools, software, and methodologies.

Requirements

• Bachelor's or Master's degree in life sciences, health informatics, computer science, or related field. Advanced degree preferred.
• Strong understanding of data structure and data systems.
• Minimum of 5+ years of experience in clinical data management
• Proven experience managing data across multiple phases of clinical trials
• Proficiency with EDC systems (e.g., Medidata Rave, Medrio).
• Strong understanding of CDISC standards (CDASH, SDTM, ADaM) as well as WHO Drug and MedDRA coding.
• Familiarity with data reporting tools is a plus.
• Thorough understanding of clinical trial processes, regulatory requirements (e.g., FDA,EMA), and GCP standards.
• Strong leadership and project management skills, with the ability to manage multiple priorities in a fast-paced environment.
• Excellent communication, problem-solving, and decision-making skills.
• Ability to work collaboratively with cross-functional teams and manage
• relationships with external vendors.
• Certified Clinical Data Manager (CCDM) or similar certification is preferred.