The business problem is to lead the DSS Study Team and represent DS as the single point of contact to meet operational objectives, deliverables, timelines, and quality in a pharmaceutical, CRO, or biotech company.
Requirements
- EDC
- eCOA
- IRT
- CDR
- SDTM
- data visualization tools
- risk based management & TMF
Responsibilities
- Lead the DSS Study Team & represent DS as the single point of contact & accountable operational lead to meet operational objectives, deliverables, timelines & quality.
- Utilize operational analytics & project management tools to optimize execution of programs & studies, to manage internal & external resources, to track project progress, & to prepare project status reports.
- Ensure adherence to various regulations, industrial standards, Standard Operating Procedures (SOPs), & to functional quality standards.
- Participate as the DS study owner in regulatory inspections & internal quality audits.
- Lead DSS innovation & process improvement initiatives & participate/lead in cross-functional initiatives.
- Responsible for coaching & mentoring team members.
Other
- Must have a Bachelor’s degree in Life Science, Nursing, Pharmacy, Computer Science, or foreign educational equivalent
- 5 years of clinical data management experience in a pharmaceutical, CRO or biotech company
- 100% Telecommuting permitted
- Must have 5 years of experience conducting phase 2 to 3 of biologics or chemical compound studies
- Must have 3 years of experience performing as project lead in clinical data management
