Clinical Data Manager

Location
Irvine, California (US)
Posted
Apr 24, 2019
Ref
962730
Required Education
Bachelors Degree
Position Type
Contract

Under the direction of management, the Clinical Reporting Lead will lead the design, development, validation, rollout of reports/dashboards using business intelligence tools (e.g., Spotfire, J-Review) and programs (e.g., SQL, PL-SQL, SAS) used in Clinical Research and Development studies. 

Responsibilities Include:  

  • Analyze Clinical Study design requirements against third party system specifications to support the implementation of electronic systems (e.g., electronic diaries) used in Clinical studies.
  • Assist in the validation of electronic systems and programs as implemented internally or through external vendors according to current regulatory requirements.
  • Act in a project management role managing various study-related projects and initiatives.
  • The Clinical Reporting Lead must be innovative and forward-thinking in support of next generation reporting needs (e.g. advanced and predictive data review).
  • The Clinical Reporting Lead must conduct activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all Allergan policies, and procedures. Allergan policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

Education and Experience:

  • BS/BA degree with 6 min. years experience, or MS degree with min. 4 years of experience in Computer Science, Life Science or elated field required
  • Strong knowledge of databases, such as Oracle
  • Knowledge of visualization tools, such as TIBCO Spotfire Knowledge of clinical reporting tools (e.g. Cognos, J-Review, SAS, SQL, etc.)
  • Strong Project Management and Communication skills
  • Ability to work with diverse user groups, lead discussions on and creation of User Requirements and Design documentation Support creation and maintenance of standard report libraries
  • Liaise with other technical personnel in related functions, as needed Strong knowledge of industry specific data standards e.g., CDASH, CDISC ODM/SDTM
  • Strong knowledge of relational databases (e.g., Oracle)
  • Knowledge: * Intermediate knowledge and understanding of Regulatory Guidelines for the use of computer systems in clinical studies
  • Intermediate knowledge of Clinical Data Management and Clinical Programming methodologies as well as current and emerging global industry standards
  • Working knowledge of global standards related to clinical study data management activities (CRF design, data standards, database design, coding and coding dictionaries, etc.) Intermediate knowledge of Research & Development (R&D) and an understanding of regulatory guidelines/requirements related to R&D (e.g., ICH, GCP, safety reporting