Description
Description:Provides input to the operational strategy and feasibility of clinical research studies, in partnership with development operations.
Responsible for the formulation of clinical development plans, trial design, protocols, amendments and conduct data review, analysis and interpretation.
Responsible for clinical research studies (methodology studies, biomarker studies, proof of mechanism studies, proof of concept studies, medical device studies, etc.) from trial design (development of outline/core elements) through clinical review, oversight and reporting.
Prepare strategy decisions, present and discuss data at relevant team, governance, external consultants
Consistent with Safety Review Plans, performs and documents regular review of individual subject safety data and performs review of cumulative safety data with the safety risk lead (as delegated by the clinical lead).
Analyze emerging study data to ensure appropriateness of the chosen subject population and proactively assesses the performance of techniques used for endpoint measures on an ongoing basis to ensure data quality
Builds relationships with external investigators to promote scientific discussions, clinical execution and avid interest in company success.
SKILLS:
Qualifications:
- Must have a science degree with experience.
- Microsoft Word experience required
- Must have research credentials and several years of on the job clinical development experience.
- Oncology development experience is a plus.