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.

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With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com.

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