Distinguished Scientist leading predictive toxicology initiatives for drug discovery at Johnson & Johnson. Collaborate with global teams to refine in vitro screening workflows and maintain toxicology expertise.
About the role
- PSSI Lead supporting clinical trial processes for CSL Behring. Overseeing site monitoring and engagement efforts with a focus on continuous improvement.
Responsibilities
- The PSSI Lead supports the processes associated with start-up, site monitoring, oversight and site engagement but strives to identify innovative continuous improvement opportunities with keen business analytics.
- They are responsible to develop and review KPI s and metrics associated with start-up, site monitoring (onsite, remote and central) and site monitoring oversight.
- With KPIs established, this role will need to continually monitor performance and critically assess their impact and collaborate with appropriate groups and the SMMO LT to identify trends and resolve issues and delinquencies.
- The PSSI Lead monitors start-up, site monitoring and oversight processes at enterprise level using dashboards and analytics; and ensures compliance through SMMO & Partner follow-up in collaboration with Clinical Compliance.
- The PSSI Lead represents SMMO on SOP and process reviews, determines impact and provides recommendations or process improvement suggestions as needed.
- Sets oversight strategies that are fit for purpose • Ensures that the monitoring oversight process is risk-based, fit for purpose and aligned with the study Compliance Oversight Plans optimizing resource availability to focus on value add tasks • Provides high-level oversight of CRO partner monitoring strategies for alignment on risk-based approaches, appropriate onsite and remote visit frequencies and percentages of source data verification and source data review.
Requirements
- A seasoned clinical trials expert with extensive experience in global clinical trials and site management, with a strong understanding of Good Clinical Practices (GCPs) and regulatory operations.
- Minimum of 10 years experience in site monitoring or central monitoring process development.
- Strong analytical thinking and problem-solving skills are essential for interpreting complex data trends and identifying risks.
- Tech and systems savvy; experience of modelling and AI
- Maintains scientific/operational knowledge and expertise to possess credibility to discuss with higher level management and peers.
- Strong interpersonal skills - establishes strong relationships with customers.
Benefits
- For more information on CSL benefits visit How CSL Supports Your Well-being | CSL
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Key member of the Translational Safety team leading predictive toxicology initiatives. Join Johnson & Johnson in developing smarter treatments with a focus on patient - centric advancements.
Principal Engineer designing high - fidelity fusion algorithms for autonomous trucks at PlusAI. Applying advanced technology to achieve centimeter - level accuracy and ensure safety in complex environments.
Russian Community Interpreter providing interpretation services for educational and non - profit clients at Mindlink. Collaborating with schools to support multilingual families in Oregon and Washington.
Portuguese Community Interpreter providing onsite and remote video interpretation for multilingual students and families. Supporting educational, local government, and nonprofit clients in WA and OR.
English teacher helping students improve their language skills with flexible online or in - person classes. No prior experience required, just a passion for teaching.
Consecutive Interpreter facilitating English - Bosnian communication across medical and customer support sectors. Engaging in note - taking, online interpreting, and improving vocabulary skills.
Medical Interpreter facilitating communication for patients with limited English proficiency at North Fulton Hospital. Supporting team development and promoting language access awareness in a healthcare setting.
Medical Interpreter facilitating effective communication between healthcare providers and patients at Stanford Health Care. Delivering high - quality interpretation and translation services in person and remotely.
Intern assisting with translation service projects and managing translation processes at Schaeffler. Collaborating on translation management tasks and supporting client communications.