Clinical Project Associate, Translational Clinical Oncology

Job description

Job Description

The Translational Clinical Oncology (TCO) department at Novartis Institutes for BioMedical Research (NIBR) is looking for a degree-level educated Clinical Project Associate to join the Clinical Operations group located in Basel, Switzerland.

You will be responsible for providing operational and program level support for several Phase I/II Oncology clinical trials under the leadership of the assigned Lead Clinical Trial Leader (CTL). This support includes the planning, set-up, maintenance and closeout of trials, the management of clinical study material, the development of specific sections of related study documents (e.g. sections of the lab manual), study tools, guidelines, and training materials as well as the implementation of issue resolution plans, as applicable.

Major accountabilities include:

• Support TCO Lead CTL and CTL in group in ensuring all trial deliverables are met according to timelines, budget, operational procedures and quality standards; Support CTL in setting up and maintaining appropriate study tracking forms
• Support CTL 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 CTL 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
• Support the Lead CTL or CTL 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 working closely with the US Clinical Operations Oncology to ensure timely Study Initiations and VDR (Verification Document Receipt) support; updates 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

Desired profile

• Bachelor's degree or equivalent higher education in life science/healthcare
• Several years of postgraduate experience with clinical study planning, execution, reporting or publishing
• Basic knowledge of Good Clinical Practice; basic knowledge of scientific principles
• Good planning, prioritization, problem solving and organizational and tracking skills
• Strong communication and presentation skills
• Proficiency in MS Office (Outlook, Excel, PowerPoint etc.) and clinical trial software
• Excellent interpersonal skills, ability to successfully interact with a wide range of people
• Strong cooperative team player, ability to be flexible and adapt to a changing environment
• Demonstrated ability to work independently and to manage multiple priorities with support
• A results-driven self-starter and decision taker; open, confident and persuasive, succeeding through influence
• A creative and innovative approach, experienced in balancing big picture thinking with detailed analysis
• Fluent English (oral and written)