- 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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Clinical Trial Manager
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TScan Therapeutics Waltham, United StatesJob Description · Job DescriptionPosition Summary: · TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Clinical Trial Associate to join our Clinical Opera ...
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Meet Waltham, United StatesSenior Clinical Trial Manager - Oncology OR Gene Therapy experience REQUIRED · Exciting position has become available on a multi-disciplinary team of world class researchers and drug developers in a growing biotech searching for a Senior CTM or CTM (based on experience) motivated ...
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Cogent Biosciences, Inc. Waltham, United StatesWho We Are · Cogent Biosciences is a publicly traded biotechnology company developing real solutions to treat genetically driven diseases. With a focus on rational drug discovery and development, we are leveraging validated biology to advance precision therapies designed to addre ...
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Stratacuity Waltham, United StatesSr CTM- Autoimmune Location: Waltham, MA (Hybrid) Therapeutic Area: Autoimmune Job Overview: The Senior Clinical Trial Manager will lead in providing trial management support for autoimmune immunotherapy programs, ensuring the preparation of study materials, managing relationship ...
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Viridian Therapeutics Waltham, United StatesAt Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today's therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driven ...
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Stratacuity Waltham, United StatesLocation: · Waltham, MA (Hybrid) · Therapeutic Area: · Immune oncology · Job Overview: · We are looking for a talented and curious professional to oversee study activities, manage relationships with study sites and vendors, and identify project risks and contingency plans in a ...
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Sr. Clinical Trial Manager 2019622
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Stratacuity: Proven Scientific Placement Waltham, United StatesLocation: Waltham, MA (Hybrid) · Therapeutic Area: Immune oncology · Job Overview: We are looking for a talented and curious professional to oversee study activities, manage relationships with study sites and vendors, and identify project risks and contingency plans in a fast-pac ...
Clinical Trial Manager - Waltham, United States - Staffmark Group
Description
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.
After you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities.
