Your responsibilities include, but are not limited to:
Coordinate cross-divisional qualification, monitoring and governance activities for TM vendors, ensuring compliance with the overall requirements for the vendor and service(s) evaluated.
Ensure issues/delays are communicated to the qualification/governance team; Support troubleshooting activities.
Maintain oversight of agreed timelines and deliverables from initiation of qualification or monitoring activities through record finalization/action completion in the Third-Party Management, Clinical Trial Quality Risk Management, and Supplier Lifecycle Management Systems.
Ensure supporting IT systems are adequately utilized, administered, and updated to ensure accuracy of information. Support inspections and audits management activities.
Generate and provide relevant reports to management and customers.
Contribute to the design and upgrade of controlled processes (e.g., new or revised Standard Operating Procedures (SOPs)), as assigned.
Participate in relevant cross-functional working groups related to quality implementation, process management and training.
Provide or assist with training of TM associates and provide support on related processes and tools. Collaborate with TM Strategic Outsourcing members on selected activities or projects. Contribute to the onboarding and mentoring of associates.
Role Requirements
Experience in clinical, outsourcing, vendor management, quality or monitoring in GxP environment.
Knowledge of GxP requirements and demonstrated quality mind-set.
Proficient in Excel, Power Point, Internet, SharePoint, Word, and other Microsoft programs
Strong communication, teamwork and customer service skills and organizational abilities
Proficient at computer and process skills; IT literacy
Ability to prioritize work, multitask, manage time appropriately in a fast paced/high volume environment
Strong operational project management experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities.
WHY NOVARTIS
769 million lives were touched by Novartis medicines in 2020, and while we\'re proud of this, we know there is so much more we could do to help improve and extend people\'s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what\'s possible, when we collaborate with courage to aggressively and ambitiously tackle the world\'s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse team\'s representative of the patients and communities we serve. Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Functional Area
Facilities & Administration
Division
Biomedical Research
Business Unit
Translational Medicine
Employment Type
Regular
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.