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Clinical Operations and Regulatory Affairs, USA | 24 Feb 2021

Associate Director/Director, Clinical Data Management

Job Title: Associate Director/Director, Clinical Data Management Job Category: Exempt/Non-Exempt
Department/Group: Biometrics Travel Required: NA
Location: Florham Park, NJ Position Type: Full Time
Level/Salary Range: Mid-Level Hiring Manager: Senior Director, Biometrics and Data Management

 

Job Description

Primary Function

  • This position plays a key role in the development of data management strategies including outsourcing and oversight strategies, standards and processes. Serves as a subject matter expert related to data management activities across multiple compounds in Oncology.  Provides and manages all data management deliverables for assigned projects. 

 

Major Responsibilities and Duties

  • Responsible for all clinical data management owned deliverables across multiple compounds in oncology, ensure that all data management related milestones are met
  • Operational responsibility from reviewing protocols, identifying data management requirements, trial execution, and other activities leading to release of data for analysis
  • Development of eCRFs and measures to ensure data consistency; engage in data reviews and data cleaning activities with the study team to ensure data quality
  • Create and maintain trackers, dashboards, metrics to monitor activities
  • Oversight responsibility for outsourced studiesto ensure compliance with the protocol, regulatory standards, GCP, policies, SOPs and other relevant guidelines
  • Collaborate with cross-functional teams on projects globally
  • Contribute to vendor selection, reviewing bids, budgets, change orders, and overall vendor management
  • Develop processes, guidelines, data standards, and SOPs at a department level
  • Participate in audits and inspections
  • Perform responsibilities in compliance with SOPs, GCP and ICH guidelines in accordance with regulatory, legal and ethical standards

 

Qualifications and Education Requirements

  • Bachelor’s degree or higher with relevant experience of at least 10 years as a clinical data manager at a study/project level
  • Detail oriented with a thorough knowledge of clinical development operations
  • Thorough knowledge of using data management technologies e.g. working in SAS environment
  • Knowledge of regulations and guidelines such as ICH, GCP, Privacy rules (HIPPA)
  • Excellent interpersonal, leadership, and communication skills
  • Strong collaborative skills and ability to work with a cross-functional team
  • Strong project management skills