• Select Source International
  • Mount Vernon , NY
  • Non-Executive Management
  • Full-Time
  • 208 S 4th Ave

Job Description

Job Title : Project Manager I

Location : New York - NY

Duration : 6+ months

Job Description:

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

Contracting

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 Reporting

Sunshine Act reporting requirements: collect data and review information submitted by funded organizations to ensure compliance with Sunshine Act; interact with Transparency department.

Grant/project reconciliation

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.

Misc.

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.


Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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