Associate Study Operations Manager

Job Description

7000 patients, 1200 clinical sites, 40 countries, 100+ clinical studies led by Novartis Clinical Sciences & Innovation (CS&I) last year.

Who are we?
We are Clinical Sciences and Innovation at Novartis. A dynamic group of Clinical Scientists who plan and execute early phase trials worldwide. From First-in-Human to Proof-of-Concept and beyond. We design and operationalize trials, ensuring they run smoothly, on time and - most importantly - with patients’ interests at the fore. Curious, unbossed and inspired; we are committed to flexibility in the workplace.

The purpose of the Associate Study Operations Manager role is to contribute to all aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance, and performance standards. You will be a member of the Clinical Trial Team and will lead specific aspects of global clinical trial(s). You will have an impact on high quality clinical studies, collaborate across our global network, partner with best-in-class physicians and scientists, be curious, innovative, and inspired.

Your key responsibilities:
Your responsibilities include but are not limited to:
• Providing operational and logistical support across multidisciplinary teams in Clinical Sciences & Innovation (CS&I) with a focus on early phase clinical studies (Phase 1 first in human/patient trials, Phase 2a proof of concept trials) and Clinical Pharmacology trials.
• Support interactions with relevant line functions including data management, drug supply management, and Novartis Country Offices
• Support interactions and communications with investigator sites and vendors as needed.
• Ensuring proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation.
• Ensuring accuracy of clinical trial management databases, systems, and resource/budget tracking tools, providing information, and following up on questions as necessary.
• Support coordinating departmental activities related to study operations support (e.g. training on areas of expertise, process improvements, on-demand study support)
May function as Subject Matter Expert (SME) and support training of other associates by providing 1:1 mentorship for mentee(s) as appropriate.

The pay range for this position at commencement of employment is expected to be between $102,400 and $153,600/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. 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 are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

Position to be based in Cambridge, MA
Please note that this role would not provide relocation.
The closing date for this role is September 19th, 2023.
Potential for 2 positions to be filled.

What you will bring to the role:
Education:
• A minimum of a bachelor’s degree, preferably in life sciences or nursing, as well as proficiency in English

Experience:
• 1+ years’ experience in early phase clinical trials operations
• Organizational skills and quality mindset with attention to detail, as well as strong communicator with demonstrated interpersonal skills.
• Basic presentation skills and ability to mentor / train small groups.
• Ability to successfully interact with a wide range of people, including global teams, different cultures, diverse experience backgrounds, as well as ability to work in a team as well as independently if required and to manage multiple priorities.
• Knowledge of GCP requirements
Office and clinical trial software IT computer literacy

Why Novartis?
236 million lives were touched by Novartis Innovative Medicines in 2022, 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 achieve here at Novartis!

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or 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.

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