Associate Clinical Trial Leader, Translational Medicine

Novartis • Cambridge, MA

10d • $103,600 - $192,400 • Hybrid

About The Position

CS&I is a dynamic group of Clinical Scientists who plan and execute Novartis’ early phase global clinical trials. From First-in-Human, to Proof-of-Concept, and beyond, we design and operationalize clinical trials, ensuring they run smoothly, on time and, most importantly, with patients’ interests in the forefront. We play a pivotal role in transitioning discovery research to clinical practice. As part of CS&I’s commitment to talent development, we have an open position for a clinical trial associate/associate clinical scientist. We are ideally looking for a lab-based associate, who is seeking to transfer their drug development skills from bench to bedside and would like to embark on a new opportunity in clinical trial management. You, as part of our team, will support Clinical Study Leads with the clinical science and operations of planning and executing early-phase trials. Collaborating internally across line functions and externally with clinical sites and vendors. Prioritizing and delivering on tasks across multiple studies. Always curious, innovative and quality focused.

Requirements

• Bachelors in life science/healthcare required; Advanced degree or equivalent education/degree in life sciences/ healthcare preferred (PhD/MD/PharmD/ Masters).
• 1+ year’s experience in clinical trials/development
• Science-based drug development role; previous experience/knowledge in a clinical trial setting and awareness of the principles of Good Clinical Practice an advantage.
• Demonstrated organizational skills. Ability to multi-task and prioritize in order to deliver on timelines.
• A detail, quality and compliance focused approach to projects.
• Strong change agility. Ability to pro-actively learn, solve issues and take accountability.
• Good collaboration skills; ability to work in a team, interact with and influence a wide range of people.
• Clear written and verbal expression of ideas; an active communicator

Responsibilities

• Supporting assigned clinical trial teams (CTT) with study tasks, across multiple therapeutic areas (non-oncology), to ensure the trial deliverables are met according to timelines and budget.
• Assist in the preparation and management of clinical and regulatory study-essential documents, including protocols and ICFs.
• Support the set-up and maintenance of the Trial Master File.
• Collaborate with internal partners including TMDP, global clinical supply, data management, regulatory, biostatistics, PK sciences, biomarker development.
• Liaise with clinical sites, external service providers and monitoring partners for study/site set-up and efficient study conduct.
• Manage and track trial information databases, ensuring accuracy.
• In collaboration with the medical expert and CTT, support ongoing scientific review of clinical trial data, data analysis and clinical study report writing/preparation.
• Ensure compliance to internal Novartis processes and Good Clinical Practice guidelines.

Benefits

• performance-based cash incentive
• annual equity awards
• health benefits
• life benefits
• disability benefits
• 401(k) with company contribution and match
• generous time off package including vacation, personal days, holidays and other leaves

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level