Sr. Director - eCOA Program Lead
Eli Lilly and Company
8 days ago
Remote friendly (Indianapolis, IN)
United States
Clinical Research and Development
About The Role (eCOA Program Lead, Therapeutic Area)
Responsibilities:
- Serve as primary eCOA authority for the therapeutic area; provide guidance to DnA Senior Directors, Clinical Development Leaders, and CDDA partners.
- Develop eCOA delivery strategies (platform selection and integrated functional sourcing).
- Anticipate eCOA needs using familiarity with TA clinical pipeline, indication package status, and Disease State Measurement Strategy (DSMS).
- Contribute to TA governance and portfolio planning with eCOA perspective on investment priorities and study design.
- Manage escalation and resolution of eCOA issues; communicate leadership updates and recommend next steps.
- Track issue patterns/root causes; drive systemic improvements through cross-functional problem-solving.
- Stay current on Atom5 platform capabilities/limitations; contribute to Atom5 roadmap recommendations.
- Lead fit-for-purpose evaluations of emerging eCOA technologies and recommend adoption aligned with TA objectives.
- Partner with DnA, Clinical Capabilities, and Quality to maintain inspection readiness; ensure alignment with GCP and 21 CFR Part 11.
- Mentor junior colleagues; lead root cause analysis/corrective actions; establish and track TA-level eCOA indicators; contribute to community knowledge exchange.
Minimum Qualifications:
- Bachelor’s in life sciences/data science/computer science or related STEM + 10+ years in clinical data management, clinical drug development, or related pharma/biotech/CRO role.
- OR Master’s degree + 7+ years in related roles.
Preferred Qualifications:
- Senior advisory/SME/portfolio leadership experience in a therapeutic area.
- DSMS experience; inspection/audit readiness/regulatory submission experience related to eCOA/clinical data.
- Modern clinical data tech (AI/ML, RPA, cloud systems); eCOA standards body familiarity (e.g., C-Path, TransCelerate, FDA PRO).
- Deep Lilly CDDA/Atom5 process knowledge; independent leadership in matrixed environments.
Benefits (if eligible):
- Company bonus; 401(k), pension; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits (e.g., EAP, fitness, clubs/activities).
Application Instructions:
- If you need accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
Responsibilities:
- Serve as primary eCOA authority for the therapeutic area; provide guidance to DnA Senior Directors, Clinical Development Leaders, and CDDA partners.
- Develop eCOA delivery strategies (platform selection and integrated functional sourcing).
- Anticipate eCOA needs using familiarity with TA clinical pipeline, indication package status, and Disease State Measurement Strategy (DSMS).
- Contribute to TA governance and portfolio planning with eCOA perspective on investment priorities and study design.
- Manage escalation and resolution of eCOA issues; communicate leadership updates and recommend next steps.
- Track issue patterns/root causes; drive systemic improvements through cross-functional problem-solving.
- Stay current on Atom5 platform capabilities/limitations; contribute to Atom5 roadmap recommendations.
- Lead fit-for-purpose evaluations of emerging eCOA technologies and recommend adoption aligned with TA objectives.
- Partner with DnA, Clinical Capabilities, and Quality to maintain inspection readiness; ensure alignment with GCP and 21 CFR Part 11.
- Mentor junior colleagues; lead root cause analysis/corrective actions; establish and track TA-level eCOA indicators; contribute to community knowledge exchange.
Minimum Qualifications:
- Bachelor’s in life sciences/data science/computer science or related STEM + 10+ years in clinical data management, clinical drug development, or related pharma/biotech/CRO role.
- OR Master’s degree + 7+ years in related roles.
Preferred Qualifications:
- Senior advisory/SME/portfolio leadership experience in a therapeutic area.
- DSMS experience; inspection/audit readiness/regulatory submission experience related to eCOA/clinical data.
- Modern clinical data tech (AI/ML, RPA, cloud systems); eCOA standards body familiarity (e.g., C-Path, TransCelerate, FDA PRO).
- Deep Lilly CDDA/Atom5 process knowledge; independent leadership in matrixed environments.
Benefits (if eligible):
- Company bonus; 401(k), pension; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits (e.g., EAP, fitness, clubs/activities).
Application Instructions:
- If you need accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation