Associate Dir. Cross TA Risk Management

The Associate Director, Cross TA Clinical Risk Management, works with trial and/or Program teams to coordinate identification, assessment, and mitigation of quality risks that could impact trial data integrity, patient safety, well-being, or rights. Executes data-driven, risk-based trial oversight to deliver quality, comply with regulatory requirements and internal procedures, and maintain inspection readiness.

Key Responsibilities:
- Participate independently in study activities; identify and assess key protocol/set-up risks and advise mitigation strategies.
- Lead regular review of risk areas with Risk Owners to evaluate mitigation progress, reduce risk, and identify new risks/needs.
- Maintain CQP (Clinical Quality Plans) in the quality repository.
- Drive quality risk monitoring reviews and coach others.
- Communicate and facilitate risk updates via Quality Working Groups and Governance Fora.
- Highlight systemic risks to RDQ CRM management.
- Ensure consistent interpretation of issues requiring quality investigations.
- Guide significant quality issues (SQI) per standards and escalate SQI to senior R&D management.
- Advise on CAPA Plan and Effectiveness Checks (Self-Identified, Inspection, Audit).
- Drive inspection readiness (inspection narratives, site preparation, key document availability, mock inspection coordination).
- Support investigator, sponsor-monitor, and third-party inspections (including post-inspection support).
- Provide independent advice on clinical research quality/compliance questions.
- Participate in cross R&D quality and cross-functional working groups to refine processes/tools.
- Provide training and coaching to peers and new employees.

Qualifications:
- Bachelor’s degree (scientific/medical/related).
- 8+ years in healthcare industry (pharma, CRO, and/or healthcare/hospital system).
- Proven GCP Quality and/or clinical trials experience.
- Excellent interpersonal and oral/written communication.
- Flexibility for changing business needs; ability to operate across culturally diverse approaches.
- Proficiency in Microsoft Office.
- Clinical trial risk management fundamentals; ICH guideline experience.
- Health authority inspection experience (FDA, EMA, and other inspectorates).

Preferred Skills:
- Knowledge of GMP, GLP, and/or GPvP.
- Strong project planning/management.
- Escalations and CAPA support/advisement.
- Data analytics/visualization tools (e.g., Tableau, Spotfire).
- Data Science and Digital Health (incl. RWE/RWD).

Benefits:
- Vacation: 120 hours/year; Sick time: 40 hours/year (CO: 48; WA: 56); Holiday pay incl. Floating Holidays: 13 days/year; Work/Personal/Family Time: up to 40 hours/year; Parental Leave: 480 hours; Bereavement Leave: 240 hours (immediate) / 40 hours (extended); Caregiver Leave: 80 hours (10 days); Volunteer Leave: 32 hours/year; Military Spouse Time-Off: 80 hours/year.