Clinical Data Manager

Position Summary:

Under the direction of the VP Clinical, Regulatory & Quality, the Clinical Data Manager will be responsible for clinical database design, validation and maintenance, as well as oversight of clinical data quality and integrity related to clinical studies. This position is also responsible for managing the clinical data specialist team.

Responsibilities:

  • Ensure clinical trial data is collected, managed and reported clearly, accurately and securely;
  • Establish and maintain policies and procedures (SOPs) for gathering, analyzing and reporting clinical data;
  • Lead and manage team of data specialist(s)/coordinator(s);
  • Resolve escalated issues arising from operations, in coordination with other functions and/or departments as required;
  • Manage clinical data related vendors;
  • Design clinical database for each clinical study;
  • Develop clinical database specifications including CRFs/eCRFs in collaboration with the clinical team;
  • Develop user requirements, edit checks, query logic/language in collaboration with the clinical team;
  • Manage roles and permissions related to clinical database;
  • Develop and manage eCRF completion and review guidelines and requirements;
  • Develop and manage source worksheet templates;
  • Develop plan for, lead, and oversee documentation of User Acceptance Testing;
  • Develop Data Management Plan in collaboration with clinical team;
  • Development of EDC training materials and documentation;
  • Train clinical database end users (including internal staff, monitors, clinical centers) on the use of the clinical database;
  • Develop pertinent clinical data reports as needed;
  • Work closely with clinical team, including monitors, to ensure quality of clinical data through data review and query management;
  • Manage and document changes to clinical database;
  • Compile data outputs and transfer to biostatisticians;
  • Execute database locks/freezes (as appropriate);
  • Archive study data and study design documentation;
  • Other related duties as required in support of company and departmental objectives.

 Qualifications:

  • B.S. in biological or medical/clinical sciences preferred with 8+ years of related experience in medical device clinical research
  • IDE Class III medical device experience a must
  • 2+ years of managerial experience
  • Working knowledge of GCPs and regulatory requirements related to clinical research
  • Working knowledge of data management practices
  • Certified MERGE eCOS Designer preferred
  • Strong organization skills and time management in a dynamic environment; ability to work on multiple projects
  • Good critical thinking and sound communication skills
  • Excellent computer skills including proficiency in Microsoft office
  • Self-motivated and detailed oriented