The posting
Band
Level 3
Job Description Summary
#LI-Hybrid Location: Cambridge, MA (USA)
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.
Job Description
Key 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.
Essential 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
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The salary for this position is expected to range between: $103,600-$192,400/year
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
To learn more about the culture, rewards and benefits we offer our people click here
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings
Salary Range
$103,600.00 - $192,400.00
Skills Desired
Clinical Research, Clinical Trial Protocols, Clinical Trials, Data Integrity, Learning Design, Life Science, Risk Monitoring, Trend Analysis
