Job Title : Project Manager I
Location : New York - NY
Duration : 6+ months
Overall management of Investigator Initiated Research (IIR) projects
Review the completeness and classification of all grant requests/proposals, entry of information into appropriate system, acknowledgment communications, and requests for additional information or documentation
Compliance review for study/project progress reports, impact reports
IRB renewal, changes, etc.
Process grant(s) per GMG direction and/or global/local review committee decision
Facilitates development of all contracts (working with Compliance, legal, regulatory)
FCPA, other review processes
Secures and manages clinical supplies and vendors
Forecasts study drug supply requirements, and initiates requests for clinical supply.
Works with PharmSci colleagues to maintain adequate drug supplies, including pooled supplies when feasible and appropriate.
Manages study drug supply inventories, and ensures timely deliveries to sites.
Monitors study milestones and requests for additional supply and funding.
Manages financial payments and tracks study progress and close
Initiates initial and milestone payments, as appropriate, working with Finance to ensure accuracy and timeliness, including vendor maintenance.
Conducts enrolment reviews on a regular basis to track patient enrolment and study progress.
Evaluates study progress reports and results for overall compliance and recommends corrective action or study termination for non-performance.
Secures study results, required documentation, and publications from completed studies/projects and implements Close procedures.
Works with the Collaborator(s), Development Operations and other Client colleagues to conduct data transfer activities in preparation for regulatory filings
Facilitates confirmed forecast transfers per direction from GMGRC team
Sunshine Act reporting requirements: collect data and review information submitted by funded organizations to ensure compliance with Sunshine Act; interact with Transparency department.
Confirms receipt of required study documentation
Monitoring and Close-out: follow up with organizations re interim status reports, post-activity reconciliation forms, and outcomes data.
Stays abreast of applicable governmental compliance laws and industry standards for IIRs, quality and education.
Initiates User-Access Requests for systems (INSPiiRE and CyberGrants)
Responsible for reporting/metrics requirements for stakeholders (per GMGRC direction)
Liaise with EMC Compliance, Process & Standards with regard to Post-CIA Grant Monitoring Program
Send mass communications via email to GMGRC stakeholders (internal and external)
Continuous Improvement: Ongoing assessment, analysis and revision of
processes and procedures for enhancement of overall GMG productivity
Ensure GMG records and files are stored/archived in compliance with Client policies and procedures.
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