Associate Dir. Cross TA Risk Management

Associate Director, Cross Therapeutic Area Clinical Risk Management (R&D Quality CRM)

Coordinates identification, assessment, and mitigation of quality risks impacting trial data integrity, patient safety, well-being and rights. Executes data‑driven, risk‑based oversight to ensure quality execution, regulatory/internal compliance, and inspection readiness.

• Independently assess key protocol/set‑up risks and advise mitigation strategies.
• Lead regular reviews with Risk Owners to track mitigation progress and identify new/additional risks.
• Maintain Clinical Quality Plans (CQP) in the quality repository for ongoing reviews.
• Drive quality risk monitoring reviews and coach others.
• Communicate risk updates via Quality Working Groups/Governance Fora.
• Support quality investigations interpretation; guide/significant quality issues escalation (SQI) to senior management.
• Advise on CAPA Plans and Effectiveness Checks.
• Drive inspection readiness (inspection narratives, site readiness, document/record availability, mock inspections with Regulatory Compliance).
• Support investigator/sponsor‑monitor/third‑party inspections (including post‑inspection support).
• Provide independent guidance on research quality/compliance; contribute to cross‑functional working groups and process/tool development.
• Train and coach peers/new employees.

• Bachelor’s degree (scientific/medical/related).
• 8+ years in healthcare industry.
• Strong GCP Quality and/or clinical trials experience.
• Excellent interpersonal, oral, and written communication.
• Flexibility; ability to work across culturally diverse/global structures.
• Proficiency in Microsoft Office.
• Clinical trial risk management fundamentals; experience with ICH guidelines.
• Health Authority Inspection experience (e.g., FDA/EMA/other inspectorates).
• Proficiency in English.

• Knowledge of GMP/GLP/GPvP.
• Project planning/management; escalation and CAPA support.
• Data analytics/visualization (Tableau/Spotfire or similar).
• Data Science/Digital Health (incl. RWE).

Up to 10%.

• Vacation: 120 hrs/year;
  Sick time: 40 hrs/year (state‑specific values noted).
• Holiday/Floating Holidays: 13 days/year.
• Work/Personal/Family Time: up to 40 hrs/year.
• Parental leave: 480 hrs;
  Bereavement leave: 240 hrs (immediate family) + 40 hrs (extended);
  Caregiver leave: 80 hrs/52‑week rolling period;
  Volunteer leave: 32 hrs;
  Military spouse time‑off: 80 hrs/year.