Clinical Data Manager

Primary Purpose

The Clinical Data Manager is responsible for data management activities for research studies. The Clinical

Data Manager works as an integral part of a cross-functional team through the lifecycle of the research

study from design through final analysis and study closeout. The Clinical Data Manager is responsible for

the completeness and accuracy of the study data in the electronic database and collaborates with internal

and external project teams on all aspects of data collection.

Responsibilities

  • Accountable for technical, scientific, fiscal, and overseeing of research projects working with staff at Emmes responsible for research support activities, including but not limited to Clinical Operations, Statistical and Scientific Innovation, Regulatory Affairs, and Pharmacovigilance.
  • Participates with cross-functional teams in design, documentation, testing, and implementation of clinical data collection studies in an electronic data capture (EDC) system.
  • Designs and/or develops study-specific electronic or paper Case Report Forms (CRFs), ensuring consistency with study protocol, clinical requirements, and accurate and efficient data collection.
  • Collaborates with the project team and other study personnel to determine data collection requirements based on the study protocol and system knowledge.
  • Documents and resolves data management issues for a protocol or group of protocols.
  • Assists with communication for internal and external teams to resolve data management issues .
  • Creates or reviews data validation check specifications. Coordinates with relevant parties in the development and testing of eCRF and data validation checks.
  • Help organize project team meetings and facilitate efficient project communication to ensure deadlines are met, participate in functional group meetings.
  • Creates and maintains study data management documents according to instructions (e.g. Data

Management Handbook, Data Management Plan, Data Validation Plan, EDC System User's Guide, EDC Training and Certification Documents).
  • Reviews data obtained through Electronic Medical Records (EMR) integration, commercially available EDC systems, or other external data sources.
  • Identifies and resolves data queries and discrepancies. Contributes to data quality metrics for a protocol or project. Performs database closure activities.
  • Demonstrates an understanding of project and corporate SOPs.
  • Participate in corporate QA meetings with the Internal Quality Audit Team (IQAT), ensure adherence with project-specific SOPs and compliance/variance table, and participate in internal/external audits, as required. Ensure adherence to GCP and ICH guidelines.
  • Ensure accurate, effective, and timely communication of study status and discrepancies to senior members of the team

Experience
  • Bachelor's or Master's degree (preferred) in health-related field, with 2 to 4 years of related data management experience in a medical/biologic or other health within pharma and/or CRO.
  • Strong data management and computer skills.
  • Knowledge of MS Excel, Word, Access, and PowerPoint is essential.
  • Demonstrated strong problem solving and analytical skills, combined with sound business judgment.
  • Ability to work proactively and effectively, with creative problem-solving and collaboration skills
  • Highly motivated with ability to work independently and as part of a multi-disciplinary team
  • Excellent verbal and written communication skills
  • Experience in therapeutic research areas that will align with Emmes' expertise, including ophthalmology, oncology, vaccine and infectious disease, transplantation or cellular therapy trials, autoimmune disease, neurology, substance use, maternal child health is preferred

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