With direction from the (ASSOCIATE) DIRECTOR, Therapeutic Area (TA) Risk Management:
The SENIOR SPECIALIST 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.
What you will be doing:
- Risk management: With direction from the (ASSOCIATE) DIRECTOR, Therapeutic Area (TA) Risk Management:
- 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 IQP (Integrated Quality Plans) risk monitoring information in quality risk repository to facilitate regular progress reviews
- Collaborates closely with risk owners in evaluation of mitigation actions and effectiveness checks on mitigations
- Facilitates risk updates to R&D Business Partners as part of the regular review cycle through cross-functional trial-level meetings and/or Quality Working Groups and Governance Forum, as applicable (trial and/or compound, as assigned)
- Actively identifies and escalates new central risk concerns to management to support collaboration and efficiencies
- Highlight new potential systemic risk to BRQC QP&S management
Issue Consultation, Issue Escalation, and Compliance Assessment:
With direction from the (ASSOCIATE) DIRECTOR, Therapeutic Area (TA) Risk 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 BRQC, provides advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self - Identified, Inspection, Audit)
Submission Support:
Pre-submission Quality Stage Gate Review (SGR)
- Supports SGR content development & follow-up Activities
- Inspection Readiness and Preparedness Support
- 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 back room support for Sponsor-Monitor inspections at J&J Sites including post inspection support. Provide 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.
Post-licensing and Acquisition (L&A) / Integration (where applicable):
With the guidance from the QP&S L&A Team and Therapeutic Area Head or Delegate:
- Support the coordination of the quality integration of the acquiring asset or company/partner and deliver robust documentation within the program/trial integration plans (90-day plan) and execute assigned responsibilities per plan.
- Provide general guidance to stakeholders
- Provide support and guidance for asset divestment
You are:
- A minimum of a Bachelor's or equivalent University degree is required. With focus in Scientific, medical, or related discipline
- Proficiency in Microsoft Office Applications
- Proficiency in speaking and writing English
- 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
- Demonstrates ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures.
Preferred:
- Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GPvP)
- Specific Therapeutic Area experience may be required depending on the position.
- Experience with fundamentals of clinical trial risk management, preferably in a global setting
- Experience working in a Quality function (Quality Management, Quality Assurance/Control and / or Compliance)
- 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
-
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
.jpg)
.jpg)
