At a Glance
- Tasks: Lead risk management for clinical trials and ensure data integrity and patient safety.
- Company: Join a global healthcare leader committed to innovation and quality.
- Benefits: Competitive salary, flexible work options, and opportunities for professional growth.
- Other info: Work in a diverse environment with global travel opportunities.
- Why this job: Make a real impact in healthcare by ensuring the highest quality standards.
- Qualifications: 10+ years in healthcare with strong clinical trial experience required.
The predicted salary is between 80000 - 100000 £ per year.
Responsibilities
- Direct the overall risk management of a Disease Area Stronghold (DAS) or development phase.
- Coordinate with CRM Representatives to identify, assess, and mitigate quality risks that could affect trial data integrity, patient rights, safety, or well-being.
- Oversee execution of data-driven, risk-based trial and program oversight activities to ensure quality, regulatory compliance, and inspection readiness.
- Establish goals, conduct mid-year and end-of-year reviews, and support career development for CRM Representatives.
- Lead strategic guidance on quality risk assessments, risk entries, and mitigation strategies and approve Clinical Quality Plans (CQP) risk monitoring information when assigned.
- Drive quality risk monitoring reviews, coach colleagues, and maintain a strategic communication framework with business partners and quality governance.
- Consult, assess, and manage significant quality issues (SQI) per corporate standards, escalating to senior R&D management and providing initial breach evaluation when necessary.
- Assist in developing and implementing Corrective and Preventative Action (CAPA) plans, monitoring effectiveness checks across inspection, audit, and self-identified contexts.
- Lead key inspection processes, develop inspection narratives, prepare sites for inspection, and coordinate mock inspections in partnership with Regulatory Compliance teams.
- Provide front-end and back-end support for Sponsor-Monitor inspections at J&J sites and remote support for investigational site inspections.
- Offer independent consultancy on research quality and compliance to business partners, ensuring consistent interpretation of international regulations and policy.
- Support and lead the coordination of quality integration for acquiring assets or companies, delivering robust documentation within integration plans and executing responsibilities per those plans.
- Provide guidance to stakeholders, contribute to Quality Agreements with development partners, and facilitate asset divestment activities when required.
Qualifications & Requirements
- Bachelor’s degree in a scientific, medical, or related discipline.
- Minimum of 10 years experience in the healthcare industry (pharmaceutical, contract research organization, or healthcare/hospital system).
- Proven strong GCP quality and/or clinical trials experience.
- Excellent interpersonal, oral, and written communication skills for cross-functional collaboration.
- Flexibility to respond to changing business needs.
- Ability to operate in culturally diverse environments and understand regional and global business structures.
- Proficiency in Microsoft Office applications.
- Required to speak and write English fluently.
- Acceptable travel up to 10%, primarily domestic with some international travel.
Required Skills
- Budget Management
- Clinical Research and Regulations
- Clinical Trials Operations
- Compliance Management
- Compliance Risk
- Continuous Improvement
- Developing Others
- Fact-Based Decision Making
- Inclusive Leadership
- Leadership
- Operations Management
- Performance Measurement
- Quality Control (QC)
- Quality Management Systems (QMS)
- Quality Standards
- Risk Assessments
- Standard Operating Procedure (SOP)
- Tactical Planning
- Vendor Selection
Preferred Skills
- Experience with fundamentals of clinical trial risk management
- Experience working to ICH guidelines
- Knowledge of GMP, GLP, and/or GPvP
- Health Authority Inspection experience (FDA, EMA, and other inspectorates)
- Strong Project Planning/Maintenance skills
- Experience in managing escalations and CAPA support/advisement
- Experience with data analytics and visualization tools (e.g., Tableau, Spotfire)
- Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease)
Location: This role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. Focus your application on the specific country that aligns with your preferred location.
Director, Clinical Risk Management Post Approval Delivery Unit employer: 7360-Janssen-Cilag Limited Legal Entity
As a leading employer in the healthcare sector, we offer a dynamic work environment that prioritises quality and compliance while fostering employee growth and development. Our culture encourages collaboration and innovation, providing opportunities for career advancement through mentorship and strategic guidance. With a commitment to maintaining high standards and supporting our employees' well-being, we ensure that every team member can thrive in their role, making a meaningful impact on patient safety and trial integrity.
Contact Details:
7360-Janssen-Cilag Limited Legal Entity Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Director, Clinical Risk Management Post Approval Delivery Unit
✨Tip Number 1
Network like a pro! Reach out to your connections in the healthcare industry, especially those who have experience in clinical risk management. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GCP and clinical trials. Be ready to discuss how you've tackled quality risks in the past. We want to see your problem-solving skills in action!
✨Tip Number 3
Showcase your leadership skills! Think of examples where you’ve led teams or projects, especially in risk management or compliance. We love candidates who can inspire and guide others.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for passionate individuals who are ready to make an impact in clinical risk management.
We think you need these skills to ace Director, Clinical Risk Management Post Approval Delivery Unit
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Director, Clinical Risk Management. Highlight your experience in risk management and clinical trials, and don’t forget to showcase your leadership skills. We want to see how you can drive quality and compliance!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role. Mention specific experiences that relate to the responsibilities listed in the job description. We love seeing passion and clarity in your writing!
Showcase Your Communication Skills:Since excellent communication is key for this position, make sure your application reflects that. Use clear and concise language, and structure your documents well. We appreciate a good flow and readability, so keep it professional yet engaging!
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the right location. Plus, it’s super easy – just follow the prompts and submit your materials!
How to prepare for a job interview at 7360-Janssen-Cilag Limited Legal Entity
✨Know Your Risk Management Inside Out
Make sure you’re well-versed in clinical risk management principles, especially those related to GCP and clinical trials. Brush up on your knowledge of quality risk assessments and how they impact trial data integrity and patient safety. This will show that you’re not just familiar with the concepts but can also apply them effectively.
✨Prepare for Scenario-Based Questions
Expect to be asked about specific situations where you've had to assess and mitigate risks. Prepare examples from your past experience that highlight your problem-solving skills and ability to lead teams through challenges. Use the STAR method (Situation, Task, Action, Result) to structure your responses clearly.
✨Showcase Your Leadership Skills
As a Director, you'll need to demonstrate strong leadership capabilities. Be ready to discuss how you've supported career development for team members or led strategic initiatives. Highlight your experience in coaching colleagues and maintaining effective communication with stakeholders.
✨Familiarise Yourself with Regulatory Standards
Since this role involves ensuring compliance with international regulations, make sure you’re up-to-date with ICH guidelines and other relevant standards. Being able to discuss how you’ve navigated regulatory challenges in the past will set you apart as a knowledgeable candidate.
