Specialist Oncology Risk Management

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Job Description:

The Specialist Clinical Risk Management works with thetrialteamstocoordinatetheidentification assessmentand mitigation ofquality risks that couldimpacttrial data integrity patient safetywellbeingor the duration of the trial theSpecialist executes data-driven risk-based trial oversight activities to deliver quality in the execution oftrials (and/or programs)compliance with regulatory requirements and internal procedures and tomaintaina continued state of inspection readiness.

Key responsibilities:

• Activelyparticipatesinallstudy activities contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical team members on effective mitigation strategies
• Participates inregular review of risk areas in collaboration with Risk Owners to evaluate progress of risk mitigations and risk reduction and toidentifypotential new risks oradditionalmitigation needs (trial and/or compound as assigned)
• Maintains CQP (Clinical Quality Plans) in quality repository tofacilitateregular progress reviewsof quality support services in addition to risks and mitigations
• Collaborates closely with risk owners in evaluation of mitigation actions and effectiveness checks on mitigations
• Communicatesandfacilitatesrisk updates to R&D colleagues as part of the regular review cyclethrough Quality Working Groups and Governance Fora as applicable(trial and/or compound as assigned).
• Highlight new potential systemic risks toRDQCRMmanagement
• Develops and ensures a consistent interpretation of issues that require quality investigations
• Provides guidance for significant quality issues (SQI) per corporate standards and escalates SQI to R&D management.
• Provides initial serious breach evaluation of quality issue that may require reporting to Health Authorities
• In collaboration with partners inRDQ provides advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self -Identified Inspection Audit)
• Supportsproactive inspection readiness activities throughout the study with trial teams to develop ongoing trial oversight inspection narrativesidentifyand prepare sites of interest for inspection (including pre-inspection visit support) ensuresavailability of key documents/recordsand coordinatesmock inspectionincollaboration with RegulatoryCompliance teams.
• Provides supportfor Investigator Sponsor-Monitor and third-party inspections includingpost inspection support
• Providesadvice on questions related to research quality and compliance from Business Partners in collaboration with other Quality Professionals andSubject Matter Experts to ensure consistent interpretation of international regulations and policy.

Qualifications:

• A minimum of a Bachelors degree (scientific medical or related discipline) is required.
• A minimum of 4 years working in the healthcare industry (pharmaceutical industry contract research organization and/or healthcare/hospital system) is required.
• Excellent interpersonal oraland written communication skills
• GCP quality and/or clinical trials experience
• Experience collaborating in a cross-functional team environment
• Flexibility to respond to changing business needs is required.
• Demonstrated ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures is required.
• Proficiency in Microsoft Office Applications is required.

• Experience with fundamentals of clinical trial risk management preferably in a global setting

• Experience working to ICH guidelines

• Health Authority Inspection experience (FDAEMAand other inspectorates)

• Strong Project Planning/Management skills

• Experience and/orproficiencywith data analytics and/or data visualization tools (i.e. Tableau Spotfire or related)

• Proven ability to analyze & interpret collective data to provide insights to drive decision-making

• Experience in managing escalations and CAPA support/advisement

• Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease)
• Requires proficiency in speaking and writing English.

• Up to 10% travel primarily domestic with some international travel.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is:

Benefits:

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.