Clinical Trial Manager Job in Central 08869, New Jersey US

 

Clinical Trial Manager – 24+ months contract in Central, NJ (Major Pharmaceutical Corporation)

 

For immediate consideration please email me your resume to ( arati.kapileshwari@maxisit.com )

 

·         Minimum Bachelor degree with 5+ years of clinical trial management experience (Sr. Manager level) to support the oncology program.

·         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.

·         Investigator contracting: Creating and negotiating 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.

·         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.

·         Vendor and partner start-up: Perform UAT on trial related external systems and related manuals (such as IVRS) if applicable.

·         Verify that IVRS is operational for the country.

·         Follow up on correct use of the IVRS system during the trial. Track costs at country level. Update country budget when necessary and provide to GTM.

·         Site closure.

·         Reconcile country budget.

·         Comply with ICH-GCP and all applicable local laws and regulations.