Clinical Trial Manager

Greenkey Resources LLC; United States; À distance; USD 90 000 - 140 000; Plein temps

Résumé du poste

Green Key Resources LLC seeks a Clinical Trial Manager to oversee remote planning, execution, and management of clinical trials in the US. You will collaborate with cross-functional teams and external vendors to ensure on-time, compliant study delivery and robust TMF/CTMS governance.

The role requires 3–4 years of CTM experience, Phase II/III exposure, and strong CRO oversight. Oncology and neuroscience trials are a plus.

Qualifications

• Bachelor’s degree in life sciences, nursing, or related field.
• Minimum 3–4 years of experience as a Clinical Trial Manager.
• Phase II and Phase III trial experience is essential.
• Strong CRO oversight and vendor management skills.
• Proficiency with CTMS, eTMF, EDC, and IRT/IWRS.
• Experience in oncology and neuroscience trials preferred.
• Ability to manage study timelines and operational issues effectively.
• Hands-on experience transitioning trial activities between CROs.
• Strong communication, organizational, and problem-solving skills.

Responsabilités

• Manage day-to-day clinical trial operations and timelines.
• Serve as the primary operational contact for assigned studies.
• Oversee vendor performance and escalate risks as needed.
• Support CRO transitions and ensure documentation transfer.
• Develop and maintain study timelines and budgets.
• Coordinate site startup activities and regulatory document collection.
• Monitor enrollment and implement recruitment strategies.
• Ensure TMF completeness and data system accuracy.
• Manage study closeout activities including site closure and database locks.

Connaissances

Vendor management

CRO oversight

Timeline management

Cross-functional coordination

Communication

Problem solving

Formation

Bachelor’s degree in life sciences or related field

Outils

CTMS

eTMF

EDC

IRT/IWRS

Description du poste

Clinical Trial Manager Overview

• The Clinical Trial Manager will oversee planning, execution, and management of clinical trials remotely.
• Collaborate with cross-functional teams and external vendors to ensure timely and quality study delivery.
• Focus on maintaining compliance with regulatory requirements and established protocols.
• Support CRO transitions, ensuring continuity and efficiency in ongoing clinical trial activities.
• Engage in vendor management, tracking deliverables and addressing operational risks.
• Coordinate study startup activities, including feasibility assessments and site activations.
• Monitor enrollment and implement patient recruitment strategies effectively.
• Ensure inspection readiness of the Trial Master File and maintain accurate study information.
• Contribute to study closeout activities, ensuring compliance and data accuracy.

Clinical Trial Manager Key Responsibilities & Duties

• Manage day-to-day clinical trial operations, ensuring adherence to protocols and timelines.
• Serve as the primary operational contact for assigned studies, coordinating internal and external teams.
• Oversee vendor performance, addressing quality issues and escalating risks as needed.
• Support CRO transitions, ensuring seamless transfer of responsibilities and documentation.
• Develop and maintain study timelines, tracking milestones and managing budgets.
• Coordinate study startup activities, including site selection and regulatory document collection.
• Monitor enrollment and implement strategies for patient recruitment and retention.
• Ensure completeness and accuracy of the Trial Master File and Clinical Trial Management System.
• Manage study closeout activities, including site closure and database lock support.

Clinical Trial Manager Job Requirements

• Bachelor’s degree in life sciences, nursing, or related field required.
• Minimum 3–4 years of experience as a Clinical Trial Manager.
• Phase II and Phase III clinical trial experience is essential.
• Strong CRO oversight and vendor management skills.
• Proficiency with clinical trial systems such as CTMS, eTMF, EDC, and IRT/IWRS.
• Experience in oncology and neuroscience clinical trials preferred.
• Ability to manage study timelines and operational issues effectively.
• Hands‑on experience transitioning clinical trial activities between CROs is desirable.
• Strong communication, organizational, and problem‑solving skills required.