Specialist Oncology Risk Management

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Job Function:

Quality

Job Sub Function:

Clinical Quality

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

The Specialist, Clinical Risk Management, works with the trial teams to coordinate the identification, assessment, and mitigation of quality risks that could impact trial data integrity, patient safety, well - being, or rights. Throughout the duration of the trial, the Specialist executes data-driven, risk-based trial oversight activities to deliver quality in the execution of trials (and/or programs), compliance with regulatory requirements and internal procedures, and to maintain a continued state of inspection readiness.

Key responsibilities:

* Actively participates in all study 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 in regular review of risk areas in collaboration with Risk Owners, to evaluate progress of risk mitigations and risk reduction, and to identify potential new risks or additional mitigation needs (trial and/or compound, as assigned)

* Maintains CQP (Clinical Quality Plans) in quality repository to facilitate regular progress reviews of quality support services in addition to risks and mitigations

* Collaborates closely with risk owners in evaluation of mitigation actions and effectiveness checks on mitigations

* Communicates and facilitates risk updates to R&D colleagues as part of the regular review cycle through Quality Working Groups and Governance Fora, as applicable (trial and/or compound, as assigned).

* Highlight new potential systemic risks to RDQ CRM management

* 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 in RDQ, provides advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self - Identified, Inspection, Audit)

* Supports proactive inspection readiness activities throughout the study with trial teams to develop ongoing trial oversight, inspection narratives, identify and prepare sites of interest for inspection (including, pre-inspection visit support), ensures availability of key documents/records and coordinates mock inspection in collaboration with Regulatory Compliance teams.

* Provides support for Investigator, Sponsor-Monitor and third-party inspections including post inspection support

* Provides advice on questions related to research quality and compliance from Business Partners in collaboration with other Quality Professionals and Subject Matter Experts to ensure consistent interpretation of international regulations and policy.

Qualifications:

* A minimum of a Bachelor's 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, oral, and written communication skills

* GCP quality and/or…