Johnson & Johnson Careers
QP&S TRIAL OVERSIGHT MANAGER
Requisition ID: 1905747954W
Janssen? We’re more than 30,000 people working hard to prevent, treat, cure and
stop some of the most devastating and complex diseases of our time. We are
committed to issues that touch everyone’s lives. Our mission is to transform
individual lives and fundamentally change the way diseases are managed,
interpreted, and prevented. We believe that challenging something is the best
way to change it.
We are looking future where the world of healthcare will be challenged by informed and empowered patients. We work for change that will improve access to medicines: the best available treatment at an affordable price. That’s why we at Janssen strive to provide access to effective and affordable medicines and related healthcare services to the people who need them.
You will provide trial and support for the drug application process as well as supplement applications. Working within the clinical teams from inception to review all critical aspects and risks including building checks and balances to mitigate these risks, assessing risk and putting controls and measures to minimize the impact of possible issues. You will be using monitoring standard checks and reviewing protocol such as informed consent and other key documenting in line with compliance and internal regulations. You will have responsibility for managing CAPA’s and internal reports for global submissions
- Developing and executing the Integrated Quality Plan (IQP), with mentorship from the QP&S IQP leader and/or the Program Leader
- Developing, maintaining and executing trial oversight activities for assigned trials/indications to ensure quality in the execution of clinical trials, compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness.
- Actively participating in pre-study activities, contributing to the identification of key risks in the clinical protocol and advising clinical team members on effective mitigation strategies.
- Ensuring that selection of investigator sites balances benefits against potential risks and that rationale for decisions are well documented.
- Monitoring risks and mitigations during study execution. Prepares periodic reports assessing critical to quality parameters for the trial and reviews these reports with applicable clinical team members to evaluate pre-defined areas of risk and/or identify new areas of risk.
- Responding independently to GCP-related compliance inquiries from clinical team members and other departments on an ongoing basis. Liaises with other members of BRQC, as appropriate, to ensure alignment and consistency with mentorship provided.
- Facilitating Quality Working Group (QWG) meetings.
- Assisting /Leading in the development of materials for Stage Gate Review, as needed.
- Develops and executes strategy to ensure inspection readiness for the clinical trial, and provides support during sponsor-monitor inspections, as needed.
- Handling problems of significant quality issues according to company policy and SOPs and in collaboration with the clinical team, and ensures timely issue resolution.
- Consulting with appropriate business partners and peers within BRQC to develop and implement Corrective and Preventative Action Plans (Self Identified, Inspection)
- Contributing to regular status reports to BioResearch Quality & Compliance (BRQC) management, as needed.
Do you have the following essential skills experience and background?
- You have previous experience in Quality and Clinical (GCP)
- You are an expert in or have a deep understanding about risk management
- Excellent team working skills
- Dedicated, 'can do' attitude
- You have excellent communication skills
- Flexibility, in order to respond to changing business needs.
- You are willing to engage, learn and share standard methodology across the team and organization
- Experience in Oncology Therapeutic area, desirable but not essential
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applications will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United Kingdom-England-High Wycombe-
North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House, United States-New Jersey-Raritan
Janssen Cilag Ltd. (7360)