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Immediate need for a Project Manager with experience in the Pharma Industry. This is a 6 months contract opportunity with long-term potential located in New York,NY. Please review the job description below:
Job ID: 17-22155
Key Responsibilities/ Key Requirements and Technology Experience:
• 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
• 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.
• 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 Pharmaceutical 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 updating GMG information on Pharmaceutical.com and internal SharePoint site(s)
• 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 Pharmaceutical policies and procedures.
Our client is a leading Pharma Industry and we are currently interviewing to fill this and other similar contract positions. Qualified candidates should apply online for immediate consideration.
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