Project Manager

• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Building:
• Salary Range: $92,625 - $97,375

Position Summary

The Eleanor and Lou Gehrig ALS Center at Columbia University is hiring a Project Manager (PM) to manager Silence ALS, a collaborative project with the n-Lorem foundation that develops individualized anti-sense oligonucleotide (ASO) therapeutics for patients with rare genetic forms of ALS. The PM will be a key member of Silence ALS with responsibilities ranging from recruiting patients to overseeing ASO treatment protocols authorized by the Food and Drug Administration (FDA) under a research or expanded access investigational new drug (IND) protocol. The PM will work closely with the ALS Center Clinical Research team and Primary Investigators to ensure compliance with regulatory agencies, including the FDA and local IRB, and accuracy of all study data.

Responsibilities

• Oversight of Silence ALS, an initiative in partnership with the n-Lorem Foundation to discover and develop novel anti-sense therapeutics for individuals with rare genetic forms of ALS.
• Preparing, submitting, and maintaining compliance of protocols and supporting documents with regulatory bodies such as the FDA, HRPO and IRB, including familiarity with IRB Reliance Agreements, Central IRBs, and Platform-based study models.
• Facilitating execution of Material Transfer Agreements and Data Use Agreements; tracking the progress of such Agreements and their associated sample/data transfers; acting as liaison between SPA/CTV, Columbia researchers, and recipients at other institutions.
• Managing all regulatory, start-up and operational aspects of Silence ALS, including CUIMC IRB submissions, communication with and monitoring of satellite sites, vendor management, operational start-up internally and externally, within the United States and internationally, and the execution of collaboration and reliance agreements as needed.
• Overseeing data entry and query resolution for Silence ALS subjects on treatment at CUIMC, delegating as appropriate. Ensures data quality by performing internal data audits and facilitating external data audits/monitoring visits.
• Developing external-facing materials, including copy for the Silence ALS website, recruitment materials (e.g. trifolds, social media, etc.), as well as investigator- and patient-facing FAQs
• Establishing and maintaining research files and documentation pertaining to regulatory. requirements for clinical trials, including CVs, financial disclosure forms, licenses, GCP trainings, CLIA/CAP certificates, and outcomes certifications, and tracking expiration dates of all the above.
• Representing the Columbia University ALS Center in meetings with monitors and stakeholders from n-Lorem, pharmaceutical companies, contract research organizations (CROs), and other Silence ALS collaborators.
• Organizing and attending regular research team meetings to update staff and investigators on the status of Silence ALS.
• Perform other related duties and responsibilities as assigned/requested.

Minimum Qualifications

• Requires a Bachelor’s degree or equivalent in education and experience, plus 4 years of related experience.

Preferred Qualifications

The ideal candidate will also demonstrate:

• Deep understanding of clinical research protocols and regulations governing clinical research.
• Ability to demonstrate professionalism and respect for subjects’ rights and individual needs.
• Ability to work cross-functionally with an interdisciplinary team.
• Excellent organizational, interpersonal, and oral/written communication skills.
• Computer literacy and familiarity with data management systems, including familiarity withLinux.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.