Our client is seeking a dynamic and motivated Clinical Data Manager to co-lead and oversee the external lab reconciliation, LNR reconciliation, data cleaning, and review processes for clinical trials. This role requires a self-starter with strong initiative, excellent problem-solving abilities, and a deep understanding of clinical data management processes. The successful candidate will 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.

Required Qualifications:

• Experience: 5 years of clinical data management experience, with a proven track record in external lab and LNR reconciliation.

• Education:

Bachelor’s degree in life sciences, clinical data management, information technology, or a related field. An advanced degree is preferred.

• Skills:

o Expertise in data reconciliation processes for clinical trials (external lab and LNR).

o Strong experience in clinical data cleaning, validation, and quality oversight.

o Familiarity with clinical database platforms (e.g., Medidata RAVE, Oracle Clinical, Veeva).

o Solid understanding of clinical data standards (CDISC, SDTM) and regulatory requirements (ICH-GCP, FDA).

o 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.