Clinical Trial Manager
Great long term contract opportunity for a Clinical Trial Manager with a local pharmaceutical company in Waltham MA. Looking for 5
years clinical research experience in a pharmaceutical/biotech, CRO setting. Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials. Will be responsible for the oversight, coordination, and execution of clinical trials in support of clinical programs in Phases I-IV of development. BS or healthcare degree required; Masters preferred.
First Shift hybrid opportunity requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. Travel domestic and international - up to 25%.
Clinical project team member works closely with the Sr CTM and/or Clinical Program Manager and is responsible for oversight, planning, and execution of assigned clinical studies, timelines, and key deliverables.
Works closely with Clinical Outsourcing on selection of CROs and vendors, RFI, RFP and bid defenses, and contract & budget negotiations.
Participates in CRO and other vendor selection along with CPM and Director Clinical Outsourcing
Oversees and works directly with CROs, vendors, field monitors and other partners.
Establishes relationships with investigators, study coordinators, site personnel and other external key stakeholders.
Accountable for developing and managing study budgets and financial reporting, including month end and quarterly flash reporting, financial reconciliation, accruals, and re-forecasting, with Clinical Outsourcing, Finance and Project Management
Responsible for study status and timelines, and feeds data into performance metrics reporting for assigned clinical projects.
Works with Patient Recruitment department and is responsible for overall recruitment strategy, enrollment projections, and meeting established targets.
Coordinates and/or participates in development of clinical study documents including ICF, monitoring plans, recruitment plans, and other program/study related documents.
Leads and participates in internal cross-functional clinical team meetings; serves as main point of contact for study-level status updates.
Presents at clinical team meetings and other forums on study progress.
Works with Study Start-up and coordinates study start-up activities including feasibility, investigational product and materials preparation, trial master file set- up, CRFs, regulatory documents, and site contracts in conjunction with other relevant departments.
Participates in database creation and user acceptance testing, provides input for edit checks, monitoring guidelines, and data cleaning activities between study sites, data management and field monitors.
Participates in SOP development, process mapping, training of junior CTMs and CTAs, and other departmental activities.
Direct line management and supervision of CTAs
Responsible for performance reviews and supporting professional development for direct reports.
After you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities. You can download it from the App Store or get it on Google Play.Estimated Salary: $20 to $28 per hour based on qualifications.
years clinical research experience in a pharmaceutical/biotech, CRO setting. Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials. Will be responsible for the oversight, coordination, and execution of clinical trials in support of clinical programs in Phases I-IV of development. BS or healthcare degree required; Masters preferred.
First Shift hybrid opportunity requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. Travel domestic and international - up to 25%.
Clinical project team member works closely with the Sr CTM and/or Clinical Program Manager and is responsible for oversight, planning, and execution of assigned clinical studies, timelines, and key deliverables.
Works closely with Clinical Outsourcing on selection of CROs and vendors, RFI, RFP and bid defenses, and contract & budget negotiations.
Participates in CRO and other vendor selection along with CPM and Director Clinical Outsourcing
Oversees and works directly with CROs, vendors, field monitors and other partners.
Establishes relationships with investigators, study coordinators, site personnel and other external key stakeholders.
Accountable for developing and managing study budgets and financial reporting, including month end and quarterly flash reporting, financial reconciliation, accruals, and re-forecasting, with Clinical Outsourcing, Finance and Project Management
Responsible for study status and timelines, and feeds data into performance metrics reporting for assigned clinical projects.
Works with Patient Recruitment department and is responsible for overall recruitment strategy, enrollment projections, and meeting established targets.
Coordinates and/or participates in development of clinical study documents including ICF, monitoring plans, recruitment plans, and other program/study related documents.
Leads and participates in internal cross-functional clinical team meetings; serves as main point of contact for study-level status updates.
Presents at clinical team meetings and other forums on study progress.
Works with Study Start-up and coordinates study start-up activities including feasibility, investigational product and materials preparation, trial master file set- up, CRFs, regulatory documents, and site contracts in conjunction with other relevant departments.
Participates in database creation and user acceptance testing, provides input for edit checks, monitoring guidelines, and data cleaning activities between study sites, data management and field monitors.
Participates in SOP development, process mapping, training of junior CTMs and CTAs, and other departmental activities.
Direct line management and supervision of CTAs
Responsible for performance reviews and supporting professional development for direct reports.
After you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities. You can download it from the App Store or get it on Google Play.Estimated Salary: $20 to $28 per hour based on qualifications.
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