Sr. Clinical Data Manager (Temp)

Job Title: Sr. Clinical Data Manager (Temp)

Job Number: 35264

Location: , 

Job Description

The Senior Clinical Data Manager will oversee all aspects of clinical data management, including database design and project oversight, ensuring the quality and accuracy of the database for clinical trials.

Responsibilities

• Coordinate and oversee data management activities from study initiation to database lock.
• Manage outsourced projects and vendors.
• Support CRF design, database validation, and author project start-up documents.
• Perform user acceptance testing and monitor project progress, ensuring timelines are met.
• Prepare data transfer agreements, database lock documentation, and data cleaning reports.
• Conduct coding for adverse events and medications, and reconcile SAEs.
• Provide data management timelines, costs, and support process improvements.
• Manage multiple trials with minimal supervision and collaborate with project teams.
• Mentor junior Data Managers.
• Ensure compliance with regulations and company policies.

Required Skills

• Bachelor’s degree in a related field.
• 5+ years of data management experience.
• Knowledge of CDISC/CDASH standards and EDC systems.
• Familiarity with medical terminology, coding dictionaries, and relevant regulations.
• Strong scientific background and understanding of clinical trials.
• Experience in biotech, pharmaceutical, or medical device industries preferred.
• Proven ability to initiate process improvements.
• Successful track record in dynamic environments, with strong organizational and communication skills.
• No regular travel required.

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