Clinical Report Lead

  •  

Irvine, CA

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted Yesterday

  by    Ella Francis Lee

Clinical Report Lead needs BS/BA degree with 6 min. years' experience, or MSdegree with min. 4 years of experience in Computer Science, Life Science or elated field required

Clinical Report Lead requires:

  • 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

Strong knowledge of industry specific data standards e.g., CDASH, CDISC

  • ODM/SDTM
  • Strong knowledge of relational databases (e.g., Oracle)

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.)

Ø Intermediate knowledge of Research & Development (R&D) and an understanding of

regulatory guidelines/requirements related to R&D (e.g., ICH, GCP, safety reporting)

Clinical Report Lead duties:

Ø The Clinical Reporting Lead will act in a project management role managing various study-related projects and initiatives.

Ø he Clinical Reporting Lead must be innovative and forward-thinking in support of next generation reporting needs (e.g. advanced and predictive data review).

Ø The Clinical Reporting Lead must conduct activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all policies, and procedures.

Ø policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives. .

Ø Manage controlled document and record archiving area and associated electronic systems.

Salary

$120K - $130K