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:
Ability to work with diverse user groups, lead discussions on and creation of User
Strong knowledge of industry specific data standards e.g., CDASH, CDISC
Intermediate knowledge and understanding of Regulatory Guidelines for the use of
Intermediate knowledge of Clinical Data Management and Clinical Programming
Working knowledge of global standards related to clinical study data management
activities (CRF design, data standards, database design, coding and coding
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.