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DATE ADDED: Mon 15/10/2018

Lead Clinical Data Manager

Stamford, USA


Job Description

• Responsible for the oversight of data management CRO activities supporting client's clinical programs from database start-up through database lock and CSR/submission.

• Serves as primary point of contact with the DM CROs, 3rd party vendors and internal study teams. 

• Works with internal team and DM CRO to develop study timelines and ensures all DM related deliverables are met.

• Oversees the development of the clinical database (DB), including user requirements, edit rules/checks, query logic and data validation.

• Oversees the development of key data management documents such as case report forms (CRF), data validation specifications, manual data review guidelines, programable edit checks, and Data Management Plans DMP) Ensures compliance with these study documents. 

• Participates in the review of Clinical research documents (e.g. Protocols, Safety Monitoring Plans, Communication Plans).

• Works with the CRO to ensure the clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and/or final database lock.

• Organizes study specific meetings (e.g. Protocol Deviation review. Medical Data review).

• Develops, tracks, analyze and report, as applicable, on data management performance metrics.

• May assist in the preparation and oversight of study audits/inspections both internal and external.

• May help develop and/or revise Data Management SOPs, Work Instructions and templates/standards incorporating the industry's best practices and any applicable Regulatory guidelines and requirements

Company Description
Green Key Resources is a premier executive recruitment firm specializing in permanent placement, contract consulting, temp-to-hire and temporary staffing within the following specialty areas: accounting-finance, healthcare nursing & allied health, pharmaceutical, financial service operations, alternative asset management, information technology, office/legal support and human resources.

Our expertise, innovation, and commitment to our candidates and clients have made Green Key an award-winning company with a proven record of success. We know the steps it takes to build a happier future, and we're here to guide you on your way.

Role: Lead Clinical Data Manager
Job Type:
Location: Stamford,

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