Specialist Oncology Risk Management
Top focus
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.
We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. All Job Posting Locations: Raritan, New Jersey, United States of America Job Description: The Specialist, Clinical Risk Management, works with t he 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
- 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
- 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 (FDA, EMA and other inspectorates) Strong Project Planning/Management skills Experience and/or proficiency with data analytics and/or data visualization tools (i.e., Tableau, Spotfire
- 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: Audit Management, Business Alignment, Business Behavior, Business Savvy, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaboration, Compliance Management, Data Analysis, Data Compilation, Escalation Management, Goal Attainment, Internal Controls, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards The anticipated base pay range for this position is : $79 000,00 - $127 650,00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company’s long-term incentive program.
- Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year
- for employees who reside in the State of Colorado –48 hours per calendar year
- for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits