Primary Job Function
This role is responsible for clinical data management (CDM) activities and operations for new and ongoing clinical research studies including the creation of, or contribution to, the Data Management Plan (DMP), the CDM start-up activities required to initiate a new clinical trial, as well as the timely creation of queries and resolution of issues related to the ongoing conduct and closeout of clinical trials
Core Job Responsibilities
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Participates in or leads the review of Clinical Research (CR) documents (e.g., protocols, reports and statistical analysis plans) by interacting with various CR groups including: Project Managers, Clinical Scientists and Statisticians.
Leads data management activities by working with Clinical Scientists, Clinical Research Associates, Clinical Safety Monitors, Systems Analysts, QC Analysts & Standards Librarian. May draft Data Management Plans and Data Review Plans as required.
Leads the development and defines standard and non-standard edit check specifications by utilizing clinical knowledge to create the parameters surrounding data items.
Provides significant input to CRF/eCRF design and address technical issues and edit check programming, as well as contributes to the development of data management reports of clinical data.
Leads Clinical Data Management activities by using Clinical knowledge, data listings and manual review of eCRFs to issue queries and clean data as required. Contributes to the monitoring of data quality during study conduct. Provides information on issues along with proposed solutions
Ensures data snapshots are ready for analysis by following the guidelines established in the DMP and/or applicable SOPs.
Ensures database lock/unlock by following the guidelines established in the DMP and/or applicable SOPs.
Ensures archiving of the study databases and related documents by following the guidelines established in the DMP and/or applicable SOPs.
Leads the preparation and presentation of data management activities by evaluating and testing new systems and by participating in task force initiatives
Supervisory / Management Responsibilities
No Direct reports
Prefer previous experience managing CRO / vendor relationships. This experience may be in the form of oversight for CRO DM deliverables and/or Core Lab DM deliverables
Comments: (Supervision Received) Works under minimal supervision. Independently determines and develops approach to solutions. Work may be reviewed upon completion for adequacy in meeting objectives.
(Supervision Provided) May provide work direction and guidance to exempt and/or skilled nonexempt levels of employees; may be asked to evaluate performance of and assist in career development planning for subordinates.
Position Accountability / Scope
(Influence/Leadership) Establishes and cultivates an extensive network of support to facilitate completion of assignments. Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel. May lead a project team. Participates in determining goals and objectives for projects. Influences middle management on technical or business solutions. May interact with vendors.
(Planning/Organization) Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule. Establishes priorities of work assignments.
(Decision Making/Impact) Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious delays and considerable expenditure of resources.
Education / Certification
Bachelor's degree plus 6+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred.
CCDM certification preferred
Minimum Experience / Training Required
(Technical/Business Knowledge (Job Skills))
· Extensive Clinical Data Management background/experience required.
· Detailed understanding of Electronic Data Capture (EDC) concepts and techniques and of clinical trial principles is required. Experience with Phase Forward’s InForm or Medidata’s RAVE EDC application is preferred.
· Must have hands-on experience with clinical data querying, issues resolution, and coordination of CDM activities.
· Excellent verbal and written communication skills and interpersonal skills are required. Experience working in a clinical development environment is required.
· Knowledge and application of business concepts, procedures and practices.
· Solid understanding of the implications of applicable laws and regulations governing Clinical Research. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
(Cognitive Skills) Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of a variety of alternatives and their impact on their business unit.
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