347355BR
Jun 20, 2022
USA

Job Description

400+. The number of dedicated and inspired professionals in the US Trial Monitoring Organization (TMO) function who are empowered to ask new questions and make bold decisions to bring lifesaving medicines and treatments to patients. Come join our curious and unbossed team and make an impact on patient’s lives every day!

Collaborating with the Clinical Study Manager, the Field Team, and the Global team, the Site Support Lead will be responsible for driving study start-up and delivering on US site activation milestones. In this role, you will ensure consistent and accurate country study start-up planning and tracking, time-line optimization, risk mitigation actions, and act as the point of reference for US study start-up intelligence (for example local regulations/requirements, timelines, metrics, and best practices).

Your responsibilities will include, but are not limited to:
• Drive site activation activities for the US in collaboration with partners, per above. Develop a detailed study start-up and site activation plan including timelines and potential risks with planned mitigations. Drive proactive risk mitigation, effective startup scenario generation and planning through data driven analysis.
• Drive local Full Protocol Package process by obtaining documentation for the country for Health Authority (HA) and/or Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) submissions; obtain global documents for site activation from the Global Study Start-Up Lead or equivalent.
• Create and manage the US-Customized Informed Consent Forms (ICFs) template utilizing using the global ICF(s) for the study. Review and negotiate site ICF pre-IRB submission, post-IRB approval, and amended ICFs during study start up. Drive IRB submission/approval process, coordinating timely answers to EC/IRB questions.
• Drive preparation, filing, and quality check verification of start-up documents, including Country and site TMF.
• Work with Contracts & Payments team to drive Investigator/site contracts negotiation and execution during study start up. Drive completion of Ready to Initiate Site (RIS) process, including requesting and confirming access to study systems (i.e.: IRT, eCRF, Central Lab, etc.).
• Lead study start-up meetings with CRAs, CRA Managers, and CSM, coordinating Site Initiation planning. Track landmarks and analyses study start-up data (metrics) to ensure efficiency, to reduce start-up timelines, and create improvements. Ensure update of accurate and complete US start-up data within company systems (e.g., IMPACT).
• Contribute to SSU lessons learned and identify trends and opportunities for start-up activities optimization and efficiency improvement.

This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectations of working hours and travel (domestic and/or international) will be defined by the Hiring Manager.

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’ll bring to the role:
• 5+ years of direct operational/managerial experience in planning and executing implementing global clinical trials with experience in developing effective working relationships with internal and external partners.
• Strong project management skills and expertise in meeting timelines.
• Ability to manage operational challenges for large complex trials with minimal supervision.
• Organizational awareness, including experience working cross-functionally and with global teams.
• Knowledge of GCPs, Local Regulations, and global drug development process.
• Adept at working independently in a complex matrix environment.
• Strong interpersonal, problem-solving, negotiation, conflict resolution, business communication and influencing skills.

Desirable:
• Related expertise from a pharmaceutical company or a contract research organization is preferred.
• Advanced degree or equivalent education/degree in life science/healthcare preferred.

Why consider 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.

COVID-19: While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected].

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 Net-work here: https://talentnetwork.novartis.com/network
Global Drug Development
GDO GDD
USA
East Hanover, NJ
Research & Development
Full Time
Regular
No
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347355BR

Site Support Lead - Trial Monitoring Organization (REMOTE)

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