Description:
Working within the Clinical Operations Department and the Data Management functional unit, the Clinical Data Manager is responsible for the clinical data management function of Trial Runners.
This includes the development of CRF/eCRF design, the generation of the data clean-up specifications, overseeing database design and testing, the review of clinical data, and the creation and maintenance of study documentation.
Responsible for planning and implementing policies, procedures, practices, and strategy for the data management function and managing the direction, planning, and execution of the data management activities, including vendor relationships, budgets, and timelines, in order to meet corporate goals and objectives.
RESPONSIBILITIES:
Manage, coach, appraise, discipline, direct, and resource Clinical Data Associate (CDA) to achieve results.
Interact with Clinical Operations, Safety Team, SAS Programmers, and Statistics to define the necessary listings needed for the support of data clean-up and database finalization.
Manage review of listings within Clinical Data Management (CDM) for quality, content, format, and output
Allocate resources to the study team in support of the quality review of final summary tables and listings used in the preparation of the Clinical Study Report (CSR), Interim Reports of sponsor defined analysis
Manage interaction with sponsors to ensure compliance to standards, timelines, relevant guidelines, and expectations of clinical data management activities
Identify and defines priorities and timeline issues
Provide data management function SOP review and development, employee training, and associated requirements
Procure and oversee outside vendors and consultants as required
Manage data management activities with regard to protocol review, study activation, data review, maintenance, and quality for multi-institutional sites
Contribute to the development and use of department performance metrics to monitor the data collection process and identify process improvement opportunities
Attend and participate in Study Project Kick-Off meetings
Create and maintain Data Management Plans
Perform and/or Manage data entry, database design, verification, and validation activities within data management group and among various sources of clinical data o CRF Design
Database Lock and End of Study Management
Requirements:
Minimum 4 years’ experience in Clinical Data Management in a biopharmaceutical setting (industry and/or CRO)
Minimum 1-year experience leading a data management team with direct reports
Demonstrated ability to effectively manage and prioritize multiple programs
Understanding of clinical data management applications and systems
Experience in developing data management procedures and processes
Excellent written and oral communication skills
Proficient knowledge of medical terminology and expertise with ICH/GCP and regulatory compliance guidelines for clinical trials
Solid understanding of clinical drug development process
Good computer skills (MS Office products, word processing, spreadsheets)
High attention to detail and accuracy and ability to manage multiple project teams
Excellent prioritization and organizational skills and demonstrated ability to delegate appropriately
Ability to work on extremely complex problems where analysis requires evaluating various factors
Ability to exercise independent judgment in developing methods, techniques and evaluation criteria for obtaining results
Advanced people management skills and positive flexible outlook
Excellent interpersonal communication skills and works effectively on cross-functional teams
EDUCATION REQUIREMENTS:
Bachelor’s Degree in Life Sciences/Computer Sciences/Mathematics/Statistics or related field, or significant relevant work experience required
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