Manager, Clinical Risk Management

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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.

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at & Johnson is currently seeking a Manager Cross Therapeutic Area Clinical Risk Management to join our R&D Quality CRM team located at a J&J office in Spring House PA; Titusville NJ; Raritan NJ; Beerse Belgium; Basel Switzerland; High Wycombe UK; Madrid Spain; Breda the Netherlands; Leiden the Netherlands

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):

Spring House PA; Titusville NJ; Raritan NJ - Requisition Number: R-071027

Beerse Belgium; Basel Madrid Spain; Breda the Netherlands; Leiden the Netherlands - Requisition Number: R-070406

High Wycombe UK - Requisition Number: R-071134

Switzerland - Requisition Number: R-071137

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

As a Manager Clinical Risk Management you will:

The Manager Cross TA Clinical Risk Management works with the trial teams and/or Program teams to coordinate the identification assessment and mitigation of quality risks that couldimpact ontrial data integrity patient safetywell being or the duration of the trial/program this Manager executes data-driven risk-based trial oversight activities to deliver quality in the execution of clinical trials (and/or programs) compliance with regulatory requirements and internal procedures and tomaintaina continued state of inspection readiness.

The responsibilities and the impact YOU will have:

• Activelyparticipatesin allstudy 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.
• Leads regular 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
• Independently drives quality risk monitoring reviews andcoachsothers on risk monitoring and mitigation reviews
• 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 senior R&D management.
• 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)
• Drivesongoing inspection readiness activities with trial teams to develop inspection narrativesidentifyand prepare sites of interest for inspection (including pre-inspectionvisitsupport) ensure availability of key documents/recordsand coordinatesmock inspectionincollaboration with RegulatoryCompliance teams.
• Provides supportfor Investigator Sponsor-Monitor and third-party inspections includingpost inspection support
• Providesindependent adviceon questions related to research quality and compliance from clinical teams in collaboration with other Quality Professionals andSubject Matter Experts to ensure consistent interpretation of international regulations and policy.

We would love to hear from YOU if you have the following essential requirements:

• A minimum of a Bachelors degree (scientific medical or related discipline) is required.
• A minimum of 8 years working in the healthcare industry (pharmaceutical industry contract research organization and/or healthcare/hospital system) is required.
• Proven strong GCP Quality and/or clinical trials experience is required.
• Excellent interpersonal oral and written communication skills to effectively collaborate in a cross-functional team environment is required.
• 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 is preferred.
• Experience working to ICH guidelines is preferred.
• Knowledge of Good Manufacturing Practice (GMP) Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GPvP) is preferred.
• Health Authority Inspection experience (FDA EMA and other inspectorates) is preferred.
• Strong Project Planning/Management skills is preferred.
• Experience in managing escalations and CAPA support/advisement is preferred.
• Experience and/or proficiency with data analytics and/or data visualization tools (i.e. Tableau Spotfire or related) to analyze/interpret collective data and provide insights to drive decision-making is preferred.
• Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease) is preferred.
• Requires proficiency in speaking and writing English.
• Up to 10% of travel primarily domestic with some international travel.

The anticipated base pay range for this position in the Netherlands is 79800.00 to 137770.00 on an annual basis and includes 8% holiday allowance plus attractive benefits.

At Johnson & Johnson we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear fair and respectful of your time.

Are you ready to make an impact

If you want to leave your personal mark and be valued for who you are Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career and that you feel you can bring your whole self to work.

We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life.

Required Skills:

Preferred Skills: