Project Manager I - Tisch Cancer Institute

Job Description

Strength Through Diversity

Ground breaking science. Advancing medicine. Healing made personal. 



Job Description:

Under the leadership of the PI of the MPN-RC and PI of Project 4 (clinical trials) and in collaboration with the Clinical Trials Manager, the Project Manager I will provide regulatory expertise for multi-center clinical trial(s) with 11 clinical sites across the US and in Canada to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of Clinical Study Management, in accordance with the appropriate quality standards including ICH/GCP and applicable global regulations. The project manager will be available to external site investigators and regulatory staff to assist with the implementation and management of the MPN-RC studies at each site. S/he supports department leadership, organizes conferences, seminars, location moves, educational initiatives and other projects, and is responsible for the creation and monitoring of timelines and other specifications.


Roles & Responsibilities:

  • Ensure all regulatory requirements, study timeframes and targets are met for assigned project(s).
  • Contribute to protocol development, including organizing, formatting, and editing
  • Ensure regulatory and safety compliance throughout trial by supporting preparation and submission of expedited and aggregate reports (e.g DSURs) to regulatory authorities
  • Reviews serious adverse event (SAE) reports from clinical trials to ensure accuracy, integrity and completeness of safety information
  • Work with sites and data monitor to track safety data and maintain consistency of safety assessments
  • Set up, organize, track and maintain clinical study and project documentation both hardcopy and electronic (e.g. Main Study Files, CRFs, etc.) including document receipt and review, scanning and indexing, quality control, copying, filing, preparation for internal/external audits, final reconciliation and archival at MSSM
  • Provide project document management support to cross-functional teams by assisting in the administration, archive and tracking of essential documents of assigned projects
  • Assist in quality control audits of clinical study and project documentation (e.g. Main/Central Study Files, Monitoring Files, etc. at MSSM
  • Assists with the development and maintenance of study specific manuals, SOPs, monitoring plan and study specific documents
  • Participates in the preparation of FDA IND initial filing, annual filing, and submitting amendments to the FDA
  • Ensures study adherence to ICH/GCP and SOPs and International guidelines by conducting reviews of labels, literature and web sites for accuracy, consistency and regulatory compliance
  • Participate in project meetings and investigator conference calls
  • Other special projects as deemed necessary. 


Requirements:

Education:

  • BA/BS degree in Life Sciences discipline required. RN, BSN in nursing preferred, or combination of equivalent experience and education.
  • CCRA or CCRC Certification from ACRP or SOCRA recommended

 

Experience:

  • Five years regulatory experience or managing operational aspects of a clinical study, preferably in oncology
  • Proven clinical development experience, including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock
  • Excellent computer skills and data management skills
  • Demonstrated ability to work collaboratively with others
  • Well developed written and verbal communication skills demonstrated by the ability to present clear instructions
  • Experience with the preparation of reports and/or presentations/communications via tools such as PowerPoint

 

Skills & Abilities:

  • Microsoft Word, PowerPoint, Excel
  • Microsoft Outlook
  • Electronic Data Capture Experience Necessary


  

Strength Through Diversity

The Mount Sinai Health System believes that diversity is a driver for excellence. We share a common devotion to delivering exceptional patient care. Yet we’re as diverse as the city we call home- culturally, ethically, in outlook and lifestyle. When you join us, you become a part of Mount Sinai’s unrivaled record of achievement, education and advancement as we revolutionize medicine together.
 
We work hard to acquire and retain the best people, and to create a welcoming, nurturing work environment where you can develop professionally. We share the belief that all employees, regardless of job title or expertise, can make an impact on quality patient care. 

Explore more about this opportunity and how you can help us write a new chapter in our story! 

Who We Are

Over 38,000 employees strong, the mission of the Mount Sinai Health System is to provide compassionate patient care with seamless coordination and to advance medicine through unrivaled education, research, and outreach in the many diverse communities we serve.
 
Formed in September 2013, The Mount Sinai Health System combines the excellence of the Icahn School of Medicine at Mount Sinai with seven premier hospital campuses, including Mount Sinai Beth Israel, Mount Sinai Beth Israel Brooklyn, The Mount Sinai Hospital, Mount Sinai Queens, Mount Sinai West (formerly Mount Sinai Roosevelt), Mount Sinai St. Luke’s, and New York Eye and Ear Infirmary of Mount Sinai.
 
The Mount Sinai Health System is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, background, or sexual orientation. 

EOE Minorities/Women/Disabled/Veterans

 

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