Job Description

OUR CLIENT:

We’re excited to be partnered with an innovative life sciences company dedicated to unraveling the complexities of human biology to improve health and longevity. Their groundbreaking work bridges research and technology, focusing on developing data-driven insights that inform next-generation healthcare solutions.

THE POSITION:

We’re seeking a Clinical Data Management Contractor to support a portfolio of clinical studies by overseeing data accuracy, integrity, and compliance throughout the entire study lifecycle.

This is a long-term contract role (40 hrs/week) with potential for extension and/or transition to a permanent position. The role requires 3–4 days per week onsite in South San Francisco.

KEY RESPONSIBILITES:

• Lead end-to-end clinical data management activities from study startup through database lock.
• Take ownership of study transitions , ensuring seamless handoffs between internal teams and external stakeholders.
• Proactively manage relationships with CROs and external partners , including oversight of data deliverables, timelines, and quality.
• Develop and manage eCRFs/CRFs, define data collection requirements, and author edit check specifications.
• Ensure data compliance with applicable regulations and internal quality standards.
• Analyze data trends through complex metrics and dashboards to drive improvements and resolve issues.
• Oversee the user acceptance testing (UAT) process to ensure robust system performance and data workflows.
• Coordinate multi-site, multi-cohort study activities, including risk management and stakeholder communication.
• Maintain essential data management documentation, including Data Management Plans, training guides, and audit support materials.
• Troubleshoot and resolve discrepancies in collaboration with clinical teams, vendors, and technical teams.
• Contribute to SOP development and ongoing process optimization initiatives.

QUALIFICATIONS:

• Bachelor's degree with 5+ years in clinical research/data management, or associate degree with 7+ years of equivalent experience.
• Strong hands-on experience with Medidata Rave ; exposure to platforms like Veeva or Medrio is a plus.
• Proven success in leading study transitions and managing CROs or vendor partnerships across complex clinical programs.
• In-depth understanding of clinical trial protocols, SAPs, DMPs, and data validation processes.
• Strong leadership and project management skills, including cross-functional collaboration.
• Familiarity with clinical data standards, regulatory requirements, and quality frameworks.
• Exceptional communication and negotiation abilities with both internal and external stakeholders.
• Able to work independently and in a matrixed, fast-paced environment.

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