- Establishes goals and objectives for CRM Representatives
- Performs mid-year and end-of-year review for CRM Representatives
- Assists in outlining and evaluating career development goals with CRM Representatives
- Works with team members to establish workstreams to update processes for efficiencies and maintaining inspection readiness.
- Coordinates upskilling knowledge workshop series for CRM Representative team development.
- Ensures CRM representatives are invited to actively participate in pre-study activities, contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical/cross functional trial team members on effective mitigation strategies.
- Ensures a consistent quality risk assessment process across the program
- Provides and leads strategic guidance to CRM representatives on quality risk assessments, risk entries, and mitigation strategies. If assigned, approves IQP (Integrated Quality Plans) risk monitoring information in quality risk repository to facilitate regular progress reviews
- Independently drives quality risk monitoring reviews and coaches others on risk monitoring and mitigation reviews
- Ensures a strategic communication framework with business partners and quality management governance to keep them informed on key quality risks and mitigations.
- Communicates and facilitates risk updates to R&D Business Partners as part of the regular review cycle through Quality Working Groups and Governance Fora, as applicable (trial and/or compound, as assigned).
- Works with risk owners to develop effective risk mitigation plans to control risks in the trial or compound level IQP
- 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 senior 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)Submission SupportPre-submission Quality Stage Gate Review (SGR)
- Leads SGR content development & follow-up activities.
- Coaches and mentors other team members on SGR for coordination and management of activities Inspection Readiness and Support
- Independently leads key inspection processes and inspection tools to maintain an ongoing inspection readiness with trial teams to develop inspection narratives, identify and prepare sites of interest for inspection (including, pre-inspection visit support), ensure availability of key documents/records and coordinates mock inspection in collaboration with Regulatory Compliance teams.
- Provides inspection support per contractual agreement for third party inspections (vendors, co-development partners and contract research organizations)
- Provides remote support for investigational site inspections including post inspection support.
- Consultancy
- Provides independent 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.
- Supports and leads the coordination of the quality integration of the acquiring asset or company/partner and delivers robust documentation within the program/trial integration plans (90-day plan) and execute assigned responsibilities per plan.
- As required, provides, and leads input into Quality Agreements with (Co-)development Partners and executes responsibilities per agreement.
- Supports and facilitates asset divestment
- A minimum of 8 years of experience working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system).
- Proficiency in Microsoft Office Applications
- Proficiency in speaking and writing English.
- Excellent interpersonal, oral, and written communication skills
- Proven strong GCP quality and/or clinical trials experience.
- Demonstrates ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures
- This position may require up to 10% domestic travel.
- This position has an estimated annual salary of 118, ,000 USD$
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Associate Director, Oncology Clinical Risk Management - Raritan, NJ, United States - Johnson & Johnson
Description
Johnson & Johnson is currently recruiting for an Associate Director, Oncology Clinical Risk Management At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease.
We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.Position Summary:
The ASSOCIATE DIRECTOR (ONC Risk Management) oversees the overall risk management of a program.
They work with the CRM Representatives to ensure the coordination of the identification, assessment, and mitigation of quality risks that could have an impact on trial data integrity, patient rights, safety, or well-being.
Throughout the duration of the program, the ASSOCIATE DIRECTOR oversees the execution of data-driven, risk-based trial and program oversight activities that deliver quality in the execution of clinical trial programs, compliance with regulatory requirements and internal procedures, and that there is a continued state of inspection readiness.
People Leader ResponsibilitiesQualificationsEducation:
A minimum of a Bachelor's or equivalent University degree is required
Required:
Other:
Job Field:
Clinical QualityOrganization: Janssen Biologics (7266)
Travel:
Yes, 10 % of the Time
