Trial Manager at LanceSoft (New Jersey - Trenton)

About LanceSoft:     compress
IT Consulting Services for Government Agencies across 50 states. Is Headquartered in Herndon, VA outside of the DC area.

About the Opportunity/Requirements:     compress
Description:
Perform country and site feasibility and summarize the information in a Country Feasibility Report.
Review and sign-off Pretrial Assessment Report and ensure follow-up and resolution of all items identified.
Create and negotiate the Clinical Trial Agreement with the investigators.
Provide the GTM with the initial study budget in liaison with local management.
Create local country recruitment and study plan, including key timelines and monitoring frequency, communicate to local team and/or to GTM and ensure that it is adhered to.
Ensure that current versions of trial documents that are listed on the Site Initiation Report and all required trial-related materials and supplies are provided to the investigational site by the site manager.
Set up the LAF
Prepare a country-specific ICF and, if applicable, a pharmacogenomic country-specific ICF in the local language(s).
Ensure that the central IEC/IRB (or in case of local IRB through site manager) is provided with current and complete copies of all documents that the IEC/IRB requests to fulfill its obligation and obtain a copy of the valid written IEC/IRB approval and all related required documents, including the composition of the IEC/IRB.
Review and ensure that local information is correct in Distribution Plan*.
Provide completed 1572 Forms and related required documents to GTM and request 1572 Form waiver letter if applicable.
Ensure that valid Insurance Certificate is in place.
Review the Site Initiation Report for completeness, sign off and ensure follow up and resolution of all the items identified.
Perform UAT on trial related external systems and related manuals (such as IVRS) if applicable.
Notify the GTM (and local CSU if applicable) when the country and an investigational site is approved to receive clinical drug supplies.
Ensure shipment of drug and non-drug supplies is arranged and monitor the process for the need for additional drug and non-drug supplies as well as relabeling of study drugs or drug transfer if required.
Report Temperature excursions regarding drug immediately to CPDQA for a Release/Reject statement and inform the site accordingly.
Ensure that all relevant trial related documentation is provided to investigators, central IEC (if applicable) and regulatory authorities (if applicable) during the trial within required timelines.
Ensure that SAEs, pregnancies and PQCs are reported within reporting timelines and according to established procedure.
If updated ICF versions are issued during the trial, prepare a country-specific ICF and, if applicable, an ICF addendum and pharmacogenomic country-specific ICF in local language(s). Ensure that the final draft(s) and if applicable site specific ICFs are reviewed and approved by the local affiliate.
Ensure any updates to 1572 Form and related required documents are provided to GTM during trial

 

Additional Information:
Also, be aware that our client conducts a criminal background check/ Test for Drug Abuse on candidates who are extended offers of employment. Therefore, before we proceed with your candidacy regarding this project opportunity, please advise us now if you have any felonies or misdemeanors.
 

Application Instructions:
Click on the *Apply To Job* button to apply to this position. Please pay close attention as you'll be given instructions on how to send your resume/CV to LanceSoft.

To further discuss this opportunity; please send me your most recent resume in a MS Word format to himanshup@lancesoft.com. Also, please take a few minutes to answer some of the questions below; they will help me qualify you candidature quickly.

Full Legal Name as in SSN:
Preferred email ID:
Day/ Evening phone numbers:
Current Location:
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Earliest availability for Phone/ On-Site interview:
Hourly Rate on W2:
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Two References: (Managerial/ Lead/ Senior Level)

Comments: (Short description of your skills)