Clinical Sciences Specialist - Clinical Trial Operations - 2 Positions

Job Description

766 million lives were touched by Novartis medicines in 2021, 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.

The Clinical Sciences Specialist supports US efforts in the execution and reporting of Innovative Medicine US (IM US) clinical trials. This role may serve as Clinical Trial Leader (CTL) or supports Clinical Trial Leaders (CTLs), for IM US Medical Affairs trials, in the execution of clinical trials including Phase I-IV, Managed Access, Investigator Initiated, Research Collaborations, and Registries. This individual will interface with the disease area US clinical team members, clinical operations, scientific operations, regulatory affairs, drug supply, data management, finance, quality, compliance, and other relevant functional areas

Your responsibilities will include, but are not limited to:
• Tracks/manages key trial milestones including monthly project status and key deliverables to senior management. Accountable for the accuracy and timeliness of trial information in all trial databases and tracking systems as assigned.
• Liaises with study investigators, site research staff, and field-based colleagues to support clinical studies. Point of first contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing trials.
• Organizes/supports investigator’s start-up meeting and study site initiation meetings. Supports trial/program leads in driving study enrollment, planning advisory boards, and performing external study feasibility with investigators.
• Tracks enrollment, develops recruitment plans, and ensures procedures are in place for appropriate optimization of patients into the clinical trial. Manages patient recruitment strategies to increase patient randomization into the trial (e.g., investigator and research nurse meetings, update newsletters, advertising, and letters to GPs).
• With support of CTL, plans the requirements for clinical trial (CT) material, ordering clinical trial material (head office or local comparators), setting up and monitoring the systems whereby material is shipped to the investigator, maintaining procedures to account for the CT material, checking the expiration of CT material and requesting extensions if necessary.
• Coordinates the movement of laboratory samples and the resulting data when central laboratory facilities are used. Contributes to the preparation and review of clinical program documents (PowerPoint presentations, IND annual report, Health Authority (HA) briefing books, clinical study protocol, regulatory documents, clinical study reports, (CSR) and submissions) and other study related documents assuring quality and consistency.
• Supports the management and tracking of trial budgets working closely with the appropriate partners. Maintains project files including: ethics committee approvals, curricula vitae of investigators/study personnel, clinical investigators brochure, protocols, case report forms instructions, consent documents, clinical trial material shipping orders, start-up meeting attendance documentation, letters of agreement, lab reference ranges, all investigator and site correspondence and schedules of payment.
• May review SAEs, ensuring Medical Director sign-off that sites are notified and that all company procedures are complied with. Responsible for maintenance of trial data in electronic Clinical Trial Management Systems (CTMS) and document management systems (DMS) that support trial activities. Provides monthly status and metric reports from various systems (e.g., CTMS and DMS).

This position will be located at the East Hanover, NJ site and will not have the ability to be located remotely. This position will require 5% travel as defined by the business (domestic and/ or international). Please note that this role would not provide relocation and only local candidates will be considered.

The pay range for this position at commencement of employment is expected to be between: $102,400 - $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

What you will bring to the role:

Education: Bachelor degree in a science related field

Required Experience:
• 3 years clinical research or research monitoring experience that provides the required knowledge, skills, abilities and experience mentoring or training others.
• Effective clinical monitoring skills and the ability to mentor/train other monitors in a positive/effective manner.
• Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices (GCPs), and applicable Standard Operating Procedures (SOPs).
• Ability to evaluate medical research data and proficient knowledge of medical terminology.
• Proven flexibility, adaptability, and effective oral/written communication skills with the ability to communicate effectively with medical personnel.
• Strong customer focus, attention to detail, effective presentation, organizational and time management skills.
• Ability to utilize problem-solving techniques applicable to a constantly changing environment.
• Good computer skills with proficiency in Microsoft Office and the ability to learn appropriate software.

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, 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 do 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