Site Support Lead - Trial Monitoring Organization (REMOTE)

327868BR
USA

Job Description

400+. The number of dedicated and inspired professionals in the US 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!

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Collaborating with the CSM, the Field Team, and the Global team, you will deliver study start-up milestones, coordinating activities from US allocation until TMF and Study Drug Reconciliation. Ensure consistent and accurate country study start-up planning and tracking, timelines optimization, and risk mitigation actions until study closeout. Be the point of reference for US study start-up intelligence (for example local regulations & requirements, timelines, metrics, best practice) and oversee activities related to importation and distribution of supplies for US TMO studies.

• Drive site activation activities for the US in collaboration, per above.
• Develop a detailed study start-up and site activation plan, timelines, potential risks with planned mitigations. Drive proactive risk mitigation and 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.
• Ensure CREDI-approved ICF is used for the US-Customized ICF template for the study. Review and negotiate the ICF pre-IRB submission, post-IRB approval, and amended ICFs.
• Drive EC/IRB submission/approval process, coordinate timely answers to EC/IRB questions.
• Act as the single point of contact for CTA Hub/HA submission process, ensure availability of relevant HA submission status and information.
• Supervise project drug supply challenges to prevent drug supply delays and interruptions. Oversee the planning, creation, distribution, and maintenance of clinical drug supplies for studies. Manage drug supply management from tracking importation, inspection, delivery to depot and entry into inventory.
• Drive and track confidentiality agreement collection.
• Work with Contracts & Payments team to drive Investigator/site contracts negotiation and execution.
• Drive completion of RIS process, including requesting and confirming access to study systems (ie: IRT, eCRF, Central Lab...).
• Drive preparation, filing, and quality check verification of start-up documents, including Country and site TMF.
• Lead study start-up meetings with CRAs, CRA Managers, and CSM and coordinate 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).
• File US start-up and activation plan.
• Contribute to SSU lessons learned and identify trends and opportunities for start-up activities optimization and efficiency improvement.


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

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.
Global Drug Development
GDO GDD
USA
East Hanover, NJ
Research & Development
Full Time
Regular
No
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327868BR

Site Support Lead - Trial Monitoring Organization (REMOTE)

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