Clinical Project Associate

Clinical Project Associate

Responsible for providing operational and program level support for several Phase I/II clinical trials under the leadership of the assigned Lead CTL. This support includes planning, set-up, maintenance and closeout of trials as applicable.

Your Responsibilities:

• Support TCO Lead CTL and CTLs in ensuring that all trial deliverables are met according to timelines, budget, operational procedures and quality standards. Assigned responsibilities can include development of specific sections of related study documents (e.g. sections of the lab manual); development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans.
• Support CTLs by setting up and maintaining appropriate study tracking forms
• Support CTLs in managing interactions with relevant functions including Drug Supply Management and Novartis local organizations (CPOs). Support CTL with all US drug supply shipping (initial and re-supply) to local CPO and all US sites to ensure timely SIV and uninterrupted patient treatment. Function as the liaison with US local depot to ensure drug delivery and relabeling occur in a timely fashion and track all drug at the central hubs. Support CTLs in all drug tracking to ensure adequate supply, monitor expiration dates and assist in relabeling as appropriate. Support CTL in tracking all batch numbers used throughout trials and assist with preparation of appropriate CSR appendices.
• Provide vendor and budgets’ tracking and support.
• Supports the Lead CTL or CTLs as the local trial leader (LTL) for US operational activities including working closely with US Clinical Operations for US study start up meetings and trial agreements, in addition to all other US based study start-up activities. Moreover, you will be working closely with the US Clin Ops Oncology to ensure timely Study Initiations and VDR (Verification Document Receipt) support; Update Global ICF templates for all trials to ensure appropriate Novartis US standard language incorporated at time of package release while acting as the US liaison with Novartis Legal and the US sites through IRB approval process.
• Set up and maintain eTMF tracker in CREDI for all studies. Provide support to CTL to ensure timely completion of eTMF tracker for CSR.
• Support CTL in delegated aspects of trial data analysis and reporting, including attendance at all relevant study meetings (i.e. CTT and dose escalation meetings). Provide support in meeting scheduling and distribution of meeting agendas/minutes
What you will bring to the role:

• Bachelor degree or equivalent education/degree qualification in life science/healthcare is the minimum required.
• 1+ year of involvement with clinical study planning, execution, reporting or publishing activities, (either at a local medical organization, investigational site, pharmaceutical company/CRO, or clinical fellowship program) preferred.
• Fluent English (oral and written)
• Good communication, organization and tracking skills, as well as detail oriented.
• Basic knowledge of Good Clinical Practice, as well as of scientific principles.

Why consider Novartis?:

927 million. That’s how many lives our products touched in 2017. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.
Oncology NIBR
Novartis Pharma AG
Research & Development
Full Time