Senior Clinical Data Manager

3 weeks ago

South San Francisco, United States Meet Full time

Job Title: Senior Manager, Clinical Data Management

Position Summary:

We are seeking a dedicated and detail-oriented Clinical Data Manager to join our team. The Clinical Data Manager will play a critical role in ensuring the accuracy, quality, and integrity of clinical trial data. This position requires collaboration with various departments and external partners to support clinical research studies from initiation through completion. The successful candidate will be responsible for overseeing data management activities, including data collection, validation, and reporting, to meet regulatory and organizational standards.

Key Responsibilities:

  • Data Management Leadership:
  • Oversee data management activities for multiple clinical studies.
  • Ensure data quality and integrity from study start-up through database lock.
  • Develop and implement data management plans, including data validation and quality control procedures.
  • Design and review case report forms (CRFs) and electronic CRFs (eCRFs) for data collection.
  • Protocol and Study Design:
  • Collaborate with clinical study teams to develop and review study protocols.
  • Define data collection requirements and ensure alignment with study objectives and regulatory requirements.
  • Vendor Management:
  • Coordinate with external vendors, such as central laboratories and EDC providers, to ensure timely and accurate data delivery.
  • Monitor vendor performance and compliance with data management standards.
  • Data Review and Cleaning:
  • Conduct data reviews and manage data queries to ensure data completeness, accuracy, and consistency.
  • Implement and oversee data cleaning activities as specified in data management plans.
  • Training and Documentation:
  • Train internal and external staff on data management procedures, EDC systems, and study-specific requirements.
  • Develop and maintain comprehensive data management documentation, including data management plans, data transfer agreements, and data review plans.
  • Regulatory Compliance:
  • Ensure compliance with industry standards (e.g., ICH-GCP, CDASH/CDISC) and regulatory requirements.
  • Participate in regulatory submissions and inspections as needed.
  • Collaboration and Communication:
  • Serve as a key member of clinical study teams, providing data management expertise and support.
  • Collaborate with cross-functional teams, including Biostatistics, Clinical Operations, and Medical Affairs, to ensure alignment and achieve study goals.
  • Report data management metrics and study progress to stakeholders.

Qualifications:

  • Bachelor's degree in a scientific or related field (Master's degree preferred).
  • Minimum of 8years of clinical data management experience in the biotechnology or pharmaceutical industry.
  • Extensive experience with Electronic Data Capture (EDC) systems; experience with Medidata Rave preferred.
  • Strong knowledge of data management processes, systems, and industry standards (e.g., ICH-GCP, CDASH/CDISC).
  • Proficiency in Microsoft Office and data management software.
  • Excellent organizational skills and attention to detail.
  • Strong problem-solving abilities and the ability to work effectively in a team environment.
  • Excellent written and verbal communication skills.
  • Experience with regulatory submissions and inspections is a plus.
  • Ability to travel occasionally as needed.

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