Sr. Clinical Data Manager

Katalyst HealthCares and Life Sciences

• $100K — $130K *
Boston, MA 02115In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Reposted Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor of Science degree with over 10 years of clinical data management experience
  • Proficiency in Electronic Data Capture (EDC) systems and CDISC standards
  • Experience in managing multiple Clinical Research Organizations (CROs) and vendors
  • 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 with attention to detail for high-quality data management
  • Commitment to compliance with Good Clinical Practice (GCP) and regulatory standards

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
  • Act as Data Management Study Lead for multiple clinical trials

Benefits

  • Comprehensive health insurance packages
  • Flexible work schedules
  • Professional development opportunities and support
  • Collaborative work environment with cross-functional teams
  • Emphasis on work-life balance
Full 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
  • ct 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 escalate 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
  • bility 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.
* Ladders Estimates

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