SUMMARY :We have partnered with a  clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases.
This Clinical Data Manager reports to the head of Biostatistics, and plays a key role in the development of data management strategies including outsourcing and oversight strategies, standards, and processes. 

RESPONSIBILITIES:

• Responsible for all clinical data management owned deliverables and ensure that all data management related milestones are met.
• Operational responsibility from reviewing protocols to identify data management requirements.
• Oversee data management vendor activities including consistency, quality and timeliness of all data management deliverables in compliance with ICH/GCP guidelines, Regulatory Authorities' regulations/guidelines, and applicable SOPs.
• Author or oversee the development of all Clinical Data Management (DM) 
• Engage in data reviews and data cleaning activities with the study team to ensure data quality.
•  Oversee data vendor through review, cleaning, auditing, validation procedures and ensure data handling compliance with regulatory requirements.
• Lead and participate in cross functional data review and report on performance and quality; review clinical data within studies and across for trend analysis. 
•  Create and maintain trackers, dashboards, metrics to monitor DM activities.
•  Develop processes, guidelines, data standards, and SOPs related to Data Management.
• Perform responsibilities in compliance with SOPs, ICH/GCP guidelines in accordance with regulatory, legal and ethical standards.

QUALIFICATIONS:

•  Bachelor's degree or higher with relevant experience of at least 5 years working in data management and at least 3 years as a clinical data manager at a study/project level.
• Detail oriented with knowledge of clinical operations and clinical data flow. 
• Familiarity with Base SAS preferred.
• Excellent communication and interpersonal skills.
•  Strong collaborative skills and ability to work with a cross-functional team.

Salary Range: $140,000 – 160,000