At a Glance
- Tasks: Coordinate risk management in clinical trials to ensure data integrity and patient safety.
- Company: Join Johnson & Johnson, a leader in healthcare innovation.
- Benefits: Competitive salary, diverse work culture, and opportunities for professional growth.
- Other info: Flexible work environment with potential for travel and global collaboration.
- Why this job: Make a real difference in patient care while working with a dynamic team.
- Qualifications: Bachelor's degree and 6 years in healthcare; strong communication and project management skills.
The predicted salary is between 55000 - 65000 £ per year.
The Senior 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 Senior 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).
- Highlights new potential systemic risk 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).
- 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 6 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 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, or 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
- Audit Management
- Business Alignment
- Business Savvy
- Clinical Research and Regulations
- Clinical Trials Operations
- Coaching
- Collaborating
- Communication
- Compliance Management
- Data Analysis
- Escalation Management
- Fact-Based Decision Making
- Problem Solving
- Quality Control (QC)
- Quality Management Systems (QMS)
- Quality Standards
- Tactical Thinking
- Vendor Selection
Preferred Skills
- Audit Management
- Business Alignment
- Business Savvy
- Clinical Research and Regulations
- Clinical Trials Operations
- Coaching
- Collaborating
- Communication
- Compliance Management
- Data Analysis
- Escalation Management
- Fact-Based Decision Making
- Problem Solving
- Quality Control (QC)
- Quality Management Systems (QMS)
- Quality Standards
- Tactical Thinking
- Vendor Selection
Senior Specialist, Clinical Risk Management in High Wycombe employer: 6010-Biosense Webster Inc. Legal Entity
At Johnson & Johnson in High Wycombe, we pride ourselves on fostering a collaborative and inclusive work culture that empowers our employees to thrive. As a Senior Specialist in Clinical Risk Management, you will benefit from extensive professional development opportunities, competitive compensation, and a commitment to work-life balance, all while contributing to meaningful projects that enhance patient safety and data integrity. Join us in a dynamic environment where your expertise will be valued and your growth supported.
Contact Details:
6010-Biosense Webster Inc. Legal Entity Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Senior Specialist, Clinical Risk Management in High Wycombe
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field and let them know you're on the lookout for opportunities. You never know who might have the inside scoop on a role that’s perfect for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of clinical risk management. Be ready to discuss how you've tackled quality risks in past roles, and don’t forget to highlight your experience with GCP and regulatory compliance.
✨Tip Number 3
Showcase your data analysis skills! Be prepared to share examples of how you've used data to drive decision-making in clinical trials. This will demonstrate your ability to contribute to trial oversight and risk management effectively.
✨Tip Number 4
Don’t just apply anywhere; apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in being part of our team at Johnson & Johnson.
We think you need these skills to ace Senior Specialist, Clinical Risk Management in High Wycombe
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience in clinical risk management. We want to see how your skills align with the responsibilities mentioned in the job description.
Showcase Your Communication Skills:Since excellent communication is key for this role, use clear and concise language in your application. We love seeing candidates who can articulate their thoughts effectively!
Highlight Relevant Experience:Don’t forget to emphasise your experience in the healthcare industry and any specific projects related to clinical trials. We’re looking for those standout moments that demonstrate your expertise.
Apply Through Our Website:For the best chance of success, make sure to submit your application through our website. It’s the easiest way for us to keep track of your application and get back to you quickly!
How to prepare for a job interview at 6010-Biosense Webster Inc. Legal Entity
✨Know Your Risks
Familiarise yourself with common clinical trial risks and mitigation strategies. Be prepared to discuss how you've identified and managed risks in past roles, as this will show your understanding of the responsibilities of a Senior Specialist in Clinical Risk Management.
✨Showcase Your Communication Skills
Since this role involves collaboration with various teams, practice articulating your thoughts clearly and concisely. Prepare examples of how you've effectively communicated risk updates or collaborated with cross-functional teams in previous positions.
✨Demonstrate Data Savvy
Brush up on your data analytics skills and be ready to discuss how you've used data to drive decision-making in clinical trials. Mention any specific tools you've used, like Tableau or Spotfire, to highlight your technical proficiency.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving abilities. Think of situations where you had to evaluate risks or implement corrective actions, and be ready to explain your thought process and the outcomes.
