Janssen Research & Development, LLC, a member of the Johnson & Johnson Family of Companies, is currently recruiting for a Trial Oversight Manager- Quality Planning & Strategy within the BioResearch Quality and Compliance (BRQC) organization located at offices in Allschwil (Switzerland) or Cherry Hill (NJ, USA). Other Janssen office locations may be considered.
In Quality Planning & Strategy, within the BRQC organization, we inspire a culture of proactive quality risk management to advance the R&D portfolio and provide innovative healthcare solutions from lab to marketplace.
The Trial Oversight Manager is a key member supporting the clinical team in identifying and mitigating quality risks that could impact trial data integrity, patient safety, or patient rights. The Trial oversight Manager is data driven and drives compliance through quality by design.
- Develops and executes trial oversight activities to manage risk according to Integrated Quality Plans (IQPs), with guidance from the QP&S IQP Leader and/or the Program Leader, to ensure quality in the execution of clinical trials, compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness. Activities may span all phases of the clinical trial, from pre-start up to database lock and generation of the clinical study report.
- Monitors risks and mitigations during study execution. Documents outcomes of activities in Trial Oversight Plans and reviews these outcomes with IQP owner and applicable clinical team members to identify additional corrective or preventative actions needed to adequately control risk.
- Routinely analyzes quality-indicating data from a number of internal and external sources to identify risk signals or potential issues in execution of the clinical trial. Facilitates identification of root cause for potential risks or issues and drives action to proactively address root cause, when necessary.
- Responds 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 guidance provided.
- Leads meetings with cross-functional trial team members, when necessary, to monitor quality metrics and vendor performance.
- Develops and executes strategy to ensure inspection readiness for the clinical trial, and provides support during sponsor-monitor inspections, as needed. Works with cross-functional trial team members to prepare them for inspections.
- Identifies issues occurring in clinical trials that may be considered Significant Quality Issues. Manages escalation of significant quality issues according to company policy and SOPs and in collaboration with the clinical team and ensures timely issue resolution of actions to resolve the issue.
- Consults with appropriate business partners and peers within BRQC to develop and implement Corrective and Preventative Action Plans (Self-Identified, Inspection)
- Contributes to regular status reports to BioResearch Quality & Compliance (BRQC) management as needed.
- Participates in QP&S, cross-BRQC Janssen, cross-functional, or cross-sector working groups to develop or refine processes, tools, and systems that support key activities.
- Trains or mentors peers and new employees as needed.
Education, Experience and Skills:
- Bachelor's degree (required) or higher (desired) in scientific, medical or related discipline
- Minimum of 8 years of experience working in execution and/or oversight of clinical trials (required) and GCP quality and/or pulmonary hypertension (PH) clinical trials experience (desirable)
- Previous experience or advanced understanding of fundamentals of clinical trial risk management and ICH E6 R2 (required).
- Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Pharmacovigilance Practice (GPvP) is desirable.
- Must have the ability to interpret global regulatory standards.
- Broad knowledge of management of standard operating procedures, good documentation practices, and records management.
- Inspection support experience (FDA, EMA and other inspectorates) desirable
- Demonstrates initiative, leadership, and provides proactive, collaborative support to cross-functional peers.
- Ability to plan and organize work in an efficient manner and work well under time constraints.
- Flexibility to respond to changing business needs
- Must have experience using MS Office and data analytics tools and systems.
- Travel Up to 10%
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
North America-United States-New Jersey-Cherry Hill
Actelion Pharmaceuticals Ltd (Swiss Confederation) (8542)