What are the responsibilities and job description for the Lead Clinical Data Manager II position at TekOne IT Services Pvt. Ltd.?
Job Title: Lead Clinical Data Manager II
Location: Princeton, NJ (Remote or Hybrid)
Duration: 6 Months
Summary
We are seeking an experienced Lead Clinical Data Manager to oversee and manage data management tasks throughout the lifecycle of clinical studies. This role requires a deep understanding of clinical data management processes and the ability to ensure high-quality and timely database locks for both in-house and offshore studies. The ideal candidate will possess strong leadership skills and the ability to collaborate effectively with cross-functional teams.
Key Responsibilities
Location: Princeton, NJ (Remote or Hybrid)
Duration: 6 Months
Summary
We are seeking an experienced Lead Clinical Data Manager to oversee and manage data management tasks throughout the lifecycle of clinical studies. This role requires a deep understanding of clinical data management processes and the ability to ensure high-quality and timely database locks for both in-house and offshore studies. The ideal candidate will possess strong leadership skills and the ability to collaborate effectively with cross-functional teams.
Key Responsibilities
- Serve as the primary point of contact for data management activities across multiple studies, ensuring compliance with regulatory and industry standards.
- Collaborate on the finalization of study protocols and design Electronic Case Report Forms (eCRFs) to facilitate accurate data collection.
- Develop and maintain essential data management documentation, including edit check specifications and Data Management Plans.
- Review eCRFs for alignment with protocols and conduct User Acceptance Testing (UAT) to ensure database structures meet project expectations.
- Conduct data quality checks to maintain the integrity of data for assigned studies, identifying and implementing process improvements.
- Oversee data management activities and documentation from CROs, ensuring alignment with best practices and performance metrics.
- Support vendor qualification processes and define the scope of work for data management tasks.
- Participate in or lead projects aimed at process improvement and knowledge management within the data management function.
- Mentor and provide guidance to junior data management professionals, fostering a collaborative team environment.
- Education: Bachelor’s degree in a relevant scientific discipline or equivalent work experience.
- Experience: Minimum of 5 years in clinical data management within pharmaceutical, biotechnology, medical device/diagnostic, or CRO settings. Significant hands-on experience leading data management activities for multiple clinical studies.
- Skills:
- Proficiency in data management systems (experience with Veeva CDMS and Veeva Vault eTMF preferred).
- Advanced knowledge of clinical data management processes, tools, methodologies, and documentation.
- Strong organizational, time management, and interpersonal skills.
- Excellent writing and verbal communication abilities.
- Proactive, accountable, and capable of managing competing priorities effectively.
- Proficient use of computer and general office equipment. Strong computer skills are essential.
