Clinical Data Manager 8/16/2016
Artech Information Systems LLC
JOB DESCRIPTIONAPPLY JOB DESCRIPTION:
Interact both verbally and through written communication with inter-organizational and outside customer contacts as well as with Central and External laboratories, CROs, etc.
-Contribute to the design of protocols
-Develop eCRF specifications according to protocol and approved standards (based on industry standards), participate in user acceptance testing
-Develop protocol specific edit check specifications, participate in user acceptance testing
-Develop and maintain project- specific Data Management plan throughout the life-cycle of the study protocol, which includes CRF annotation, database specifications, edit checks and other pertinent data management documents
-Provide training for team members in data management procedures
-Prioritize tasks with respect to pre-determined timelines
-Provide direction and coordinate data management activities to ensure timely database lock and release of data for interim and final analyses
-Provide oversight, monitor and track quality of vendor data management deliverables, ensuring audit practices are in place to validate the quality of EDC database content as well as external electronic data transfers
-Perform metrics on data management processes and guidelines to evaluate efficiency, accuracy, and speed in cleaning clinical study data and locking database for study reporting
-Ensure data processing activities are performed according to protocol, GCP and SOPs -Participate in hands-on data review and query management as necessary.
Clinical Data Management System experience (e.g., Clintrial, Oracle Clinical) and understanding of database/programming concepts preferred.
HIGH LEVEL OF KNOWLEDGE IN THE USE OF DATA MANAGEMENT APPLICATIONS AND DATABASE/FILE STRUCTURES; ABLE TO USE SQL, SAS AND OTHER PROGRAMMING/QUERY LANGUAGES; ABLE TO ACQUIRE AND APPLY NEW TECHNICAL SKILLS.
Knowledge of industry standards and practices.
Aware of the clinical development process.
Communicates effectively with study teams and departmental associates. Establishes rapport and collaborates with others both inside and outside the company; builds constructive and effective relationships; demonstrates flexibility through effective negotiations, can be direct yet diplomatic.
Detects problems, issues, and delays quickly, and proactively works to minimize the impact; follows through on all tasks and ensures high quality results.
Consistently meets deadlines according to accepted levels of quality, paying attention to details.
Learns quickly when facing new problems; uses rigorous, objective logic and methods to solve difficult problems with effective solutions; follows implementation plans through to completion.
Sets clear assignments as well as clear objectives and measures; monitors process, progress and results.
Project Management skills
Ability to prioritize activities
EXPERIENCE IN EARLY PHASE DEVELOPMENT STUDIES PREFERABLE
US: BACHELOR DEGREE, PREFERABLY IN A LIFE SCIENCE OR MATHEMATICS-RELATED AREA (E.G. COMPUTER SCIENCES) AND/OR WITH 8+ YEARS INDUSTRY EXPERIENCE WITH AT LEAST 2 YEARS OF CLINICAL DATA MANAGEMENT EXPERIENCE.