Advantage Technical
Clinical Trial Manager - Phase 1 Studies
Advantage Technical, Boston, Massachusetts, us, 02298
Clinical Trial Manager – Phase 1 Studies
Location:
Hybrid (3 days/week onsite)
Pay Rate:
$125/hour
Position Overview
The Clinical Trial Manager (CTM) plays a critical role in early‑stage clinical development, leading operational execution for Phase 1 clinical studies. This position oversees clinical site operations, ensures alignment with organizational objectives, and drives high‑quality, compliant, and timely delivery of clinical trials.
The CTM will provide strategic and operational leadership across trial planning, initiation, execution, vendor oversight, budgeting, and risk management. This role requires deep expertise in early‑phase clinical operations and the ability to collaborate effectively across global, cross‑functional teams.
Key Responsibilities
Clinical Operations Leadership
Develop strategy and methodology for clinical operations programs.
Ensure all clinical trials are conducted in full compliance with regulatory requirements and remain inspection‑ready.
Lead planning, oversight, and delivery of clinical programs from Start of Development through Proof of Clinical Principle/Concept.
Oversee study budgets, timelines, and operational execution in alignment with ICH‑GCP and local/global regulations.
Study Execution & Oversight
Provide strategic input on training materials, program standards, clinical development plans, and regulatory documents (e.g., IBs, CSRs, safety updates, briefing books, submission dossiers).
Ensure timely and high‑quality contributions to clinical trial protocols and evidence plans.
Collaborate with Clinical Trial Supply to determine comparator sourcing strategies when applicable.
Lead site selection, feasibility, and patient recruitment strategies to meet enrollment targets.
Data & Systems Management
Participate in database development and UAT; contribute to edit checks, monitoring guidelines, and data cleaning processes.
Support SOP development, process mapping, and training of CTAs and other team members.
Cross‑Functional Collaboration
Partner with global internal stakeholders including technical leads, project management, regulatory affairs, and other functional teams.
Ensure seamless communication and alignment across all operational partners and vendors.
Minimum Education & Experience Requirements
M.S. or Ph.D. in a basic science discipline.
10+ years of Clinical Operations experience within biotech, pharmaceutical, or CRO environments.
Strong ability to identify and champion process improvements focused on reliability, efficiency, cost, and quality.
Thorough understanding of FDA/EMEA regulations, ICH guidelines, and GCP requirements.
Experience leading global clinical trials (experience outside US/EU/Asia/Americas preferred).
Advanced experience in patient recruitment, safety oversight, non‑compliance management, document management, investigational product handling, and budget oversight.
Proven success in planning and executing clinical trial operations.
Experience developing clinical protocols, SOPs, CSRs, and NDA‑supporting documentation.
Demonstrated ability to lead business process transformation and drive organizational change.
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Hybrid (3 days/week onsite)
Pay Rate:
$125/hour
Position Overview
The Clinical Trial Manager (CTM) plays a critical role in early‑stage clinical development, leading operational execution for Phase 1 clinical studies. This position oversees clinical site operations, ensures alignment with organizational objectives, and drives high‑quality, compliant, and timely delivery of clinical trials.
The CTM will provide strategic and operational leadership across trial planning, initiation, execution, vendor oversight, budgeting, and risk management. This role requires deep expertise in early‑phase clinical operations and the ability to collaborate effectively across global, cross‑functional teams.
Key Responsibilities
Clinical Operations Leadership
Develop strategy and methodology for clinical operations programs.
Ensure all clinical trials are conducted in full compliance with regulatory requirements and remain inspection‑ready.
Lead planning, oversight, and delivery of clinical programs from Start of Development through Proof of Clinical Principle/Concept.
Oversee study budgets, timelines, and operational execution in alignment with ICH‑GCP and local/global regulations.
Study Execution & Oversight
Provide strategic input on training materials, program standards, clinical development plans, and regulatory documents (e.g., IBs, CSRs, safety updates, briefing books, submission dossiers).
Ensure timely and high‑quality contributions to clinical trial protocols and evidence plans.
Collaborate with Clinical Trial Supply to determine comparator sourcing strategies when applicable.
Lead site selection, feasibility, and patient recruitment strategies to meet enrollment targets.
Data & Systems Management
Participate in database development and UAT; contribute to edit checks, monitoring guidelines, and data cleaning processes.
Support SOP development, process mapping, and training of CTAs and other team members.
Cross‑Functional Collaboration
Partner with global internal stakeholders including technical leads, project management, regulatory affairs, and other functional teams.
Ensure seamless communication and alignment across all operational partners and vendors.
Minimum Education & Experience Requirements
M.S. or Ph.D. in a basic science discipline.
10+ years of Clinical Operations experience within biotech, pharmaceutical, or CRO environments.
Strong ability to identify and champion process improvements focused on reliability, efficiency, cost, and quality.
Thorough understanding of FDA/EMEA regulations, ICH guidelines, and GCP requirements.
Experience leading global clinical trials (experience outside US/EU/Asia/Americas preferred).
Advanced experience in patient recruitment, safety oversight, non‑compliance management, document management, investigational product handling, and budget oversight.
Proven success in planning and executing clinical trial operations.
Experience developing clinical protocols, SOPs, CSRs, and NDA‑supporting documentation.
Demonstrated ability to lead business process transformation and drive organizational change.
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