Senior Clinical Data Manager

5 days ago

Princeton, New Jersey, United States TekWissen ® Full time
Job Summary

We are seeking a highly skilled and experienced Clinical Data Manager to join our team at TekWissen ®. As a key member of our clinical trials team, you will be responsible for overseeing the external lab reconciliation, LNR reconciliation, data cleaning, and review processes for clinical trials.

Key Responsibilities
  • Co-lead and oversee the external lab reconciliation and LNR reconciliation processes for clinical trials.
  • Ensure that all data-related activities are conducted in compliance with regulatory standards, study protocols, and company objectives.
  • Play a critical role in study setup, execution, and lock, ensuring that all data-related activities are conducted in compliance with regulatory standards, study protocols, and company objectives.
  • Develop and implement data cleaning and validation processes to ensure data accuracy and quality.
  • Collaborate with cross-functional teams to ensure seamless execution of clinical trials.
Requirements
  • 5+ years of clinical data management experience, with a proven track record in external lab and LNR reconciliation.
  • Bachelor's degree in life sciences, clinical data management, information technology, or a related field. An advanced degree is preferred.
  • Expertise in data reconciliation processes for clinical trials (external lab and LNR).
  • Strong experience in clinical data cleaning, validation, and quality oversight.
  • Familiarity with clinical database platforms (e.g., Medidata RAVE, Oracle Clinical, Veeva).
  • Solid understanding of clinical data standards (CDISC, SDTM) and regulatory requirements (ICH-GCP, FDA).
  • Demonstrated ability to manage study setup, conduct, and lock processes.
Key Competencies
  • Self-starter: Demonstrates a high level of initiative and the ability to independently drive projects forward.
  • Problem-solving: Proven ability to identify, analyze, and resolve data issues efficiently.
  • Attention to detail: High level of accuracy in managing complex clinical data and reconciliation processes.
  • Collaboration: Strong interpersonal and communication skills, with the ability to work effectively across functional teams.
  • Learning Agility: Willingness and ability to quickly grasp new tools, systems, and processes.

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