Associate Dir. Cross TA Risk Management

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

Job Description
Works with trial/program teams to coordinate identification, assessment, and mitigation of quality risks impacting trial data integrity, patient safety/well-being, or rights. Executes data-driven, risk-based trial oversight to ensure quality execution, regulatory compliance, internal procedures, and ongoing inspection readiness.

Key Responsibilities
- Participate independently in study activities; identify and assess key risks in protocol/set-up and advise on mitigation strategies.
- Lead regular review of risk areas with Risk Owners to evaluate progress, reduce risk, and identify new risks/mitigation needs.
- Maintain Clinical Quality Plans (CQP) in the quality repository for progress reviews of quality support services, risks, and mitigations.
- Drive quality risk monitoring reviews and coach others.
- Communicate/facilitate risk updates via Quality Working Groups/Governance Fora.
- Highlight systemic risks to RDQ CRM management.
- Ensure consistent interpretation of issues requiring quality investigations.
- Provide guidance for significant quality issues (SQI) and escalate SQI to senior R&D management.
- Advise on CAPA Plans and Effectiveness Checks (self-identified, inspection, audit).
- Drive inspection readiness: develop inspection narratives, prepare sites, support pre-inspection visits, ensure key documents/records, coordinate mock inspections with Regulatory Compliance.
- Support investigator/sponsor-monitor/third-party inspections, including post-inspection support.
- Provide independent advice on research quality and compliance in collaboration with Quality professionals/SMEs.
- Participate in cross-functional working groups to refine processes/tools/systems for quality.
- Provide training and coaching to peers and new employees as needed.

Qualifications
- Bachelor’s degree (scientific/medical/related) required.
- 8+ years in healthcare industry (pharma, CRO, and/or healthcare/hospital) required.
- Strong GCP Quality and/or clinical trials experience required.
- Excellent interpersonal and oral/written communication required.
- Flexibility for changing business needs required.
- Experience operating across culturally diverse styles/business approaches required.
- Proficiency in Microsoft Office required.
- Clinical trial risk management fundamentals required.
- Experience working to ICH guidelines required.
- Health authority inspection experience (FDA, EMA, other inspectorates) required.
- English speaking/writing proficiency required.
- Up to 10% travel (primarily domestic) required.

Preferred Skills
- Knowledge of GMP, GLP, and/or GPvP.
- Strong project planning/management.
- Experience managing escalations and CAPA support/advisement.
- Data analytics/visualization tools (e.g., Tableau, Spotfire) for decision-making.
- Data science and digital health (incl. RWE/RWD).

Benefits (time off)
- Vacation: 120 hours/calendar year; Sick time: 40 hours (CO: 48; WA: 56); Holiday pay incl. floating holidays: 13 days; Work/Personal/Family time: up to 40 hours; Parental leave: 480 hours; Bereavement leave: 240 hours (immediate) / 40 hours (extended); Caregiver leave: 80 hours (52-week rolling period); Volunteer leave: 32 hours; Military spouse time-off: 80 hours.

Application Instructions
Applies to multiple countries/requisition postings; applications considered a single submission across requisition numbers.