Sr. Clinical Data Manager

Katalyst CRO; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking a skilled professional to lead clinical data management activities in Boston, Massachusetts. The successful candidate will ensure data quality and integrity across pivotal trials while collaborating with cross-functional teams. A Bachelor of Science degree and over 10 years of experience in clinical data management are required.

Ideal candidates should possess proficiency in EDC systems, strong knowledge of database structures, and excellent organizational skills. This role demands commitment to compliance with regulatory standards and effective communication within teams.

Qualifications

• 10+ years of clinical data management experience.
• Proficiency in EDC systems and CDISC standards.
• Experience managing CROs/vendors for data quality.

Responsibilities

• Lead clinical data management activities ensuring data quality.
• Collaborate with teams for clinical trial data management.
• Oversee vendor management and compliance with regulations.

Skills

Clinical data management

EDC systems

CDISC standards

Data quality management

Interpersonal skills

Organizational skills

Communication skills

Education

Bachelor of Science degree

Tools

Database structures

Data visualization technologies

Job description

Responsibilities

• Lead clinical data management activities for pivotal trials, ensuring data quality and integrity.
• Collaborate with cross-functional teams to support clinical trial data management processes.
• Oversee vendor management and ensure compliance with regulatory standards.
• Drive development and implementation of data management plans and validation activities.
• Coordinate data cleaning and reporting activities to meet project goals.
• Support database design, validation, and maintenance for clinical trials.
• Ensure adherence to Good Clinical Practice (GCP) and regulatory requirements.
• Provide leadership and guidance to data management teams and stakeholders.
• Act as Data Management Study Lead for multiple clinical trials.
• Manage vendor relationships and ensure timely delivery of data management services.
• Develop and maintain critical data management documentation and plans.
• Coordinate data transfer setups and validations, ensuring consistency with agreements.
• Perform supplemental data reviews and quality checks as per validation specifications.
• Participate in study document reviews, including protocols and statistical analysis plans.
• Ensure compliance with CDISC standards and clinical research regulations.
• Report project status and elevate study-related issues to senior leadership.

Requirements

• Bachelor of Science degree with 10+ years of clinical data management experience.
• Proficiency in EDC systems, CDISC standards, and clinical research regulations.
• Experience managing multiple CROs/vendors and ensuring data quality.
• Strong knowledge of database structures and data visualization technologies.
• Excellent interpersonal, organizational, and communication skills.
• Ability to prioritize tasks and work effectively in a fast-paced environment.
• Logical thinking and attention to detail for high-quality data management.
• Commitment to maintaining compliance with GCP and regulatory standards.