CTM II

Accountabilities: The CTM II will oversee clinical trial management activities, ensuring studies are delivered according to timelines, quality standards, budgets, and regulatory requirements. This role requires strong collaboration, risk identification, and leadership skills to support successful clinical operations.

Manage site oversight, clinical monitoring activities, and central monitoring deliverables while maintaining patient safety, protocol compliance, GCP standards, and data integrity.

Oversee site activities from activation through closeout, including recruitment progress, investigator payments, and operational milestones.

Review study protocols, scopes of work, budgets, and contractual requirements to ensure alignment across clinical project teams.

Identify operational risks using clinical data, performance metrics, and reporting tools, and implement mitigation strategies when required.

Support risk assessment activities and ensure monitoring strategies, clinical plans, and compliance requirements are properly executed.

Participate in study meetings, including project kickoffs, and provide updates on progress, risks, and operational challenges.

Act as an escalation point for site communications, supporting issue resolution with investigators and clinical teams.

Collaborate with cross-functional groups such as data management, patient recruitment, study startup, medical monitoring, and quality teams to achieve study objectives.

Develop, maintain, and improve clinical study tools, templates, dashboards, and tracking systems.

Ensure clinical systems such as CTMS, EDC, ePROs, TMF, and monitoring dashboards are accurately maintained and support operational visibility.

Provide training and guidance to study teams on protocols, clinical documentation, procedures, and timelines.

Oversee CRA and central monitor resources, assignments, performance, and compliance with study requirements.

Review monitoring documentation and ensure reports, correspondence, and deliverables meet quality expectations and regulatory standards.

Support inspection readiness activities and contribute to continuous improvement initiatives within clinical operations.

Requirements:

The ideal candidate has experience managing clinical trials in an international environment, with strong knowledge of monitoring practices, regulatory requirements, and risk-based approaches. They should demonstrate leadership, communication, and problem-solving abilities.

Bachelor’s degree, RN qualification, or equivalent combination of education, training, and relevant experience.

Demonstrated experience leading clinical teams and supporting delivery of project milestones.

Proven expertise in clinical site management and monitoring, including clinical or central monitoring activities.

Experience working within international clinical research environments.

Knowledge of Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.

Understanding of clinical trial financial principles and budget management.

Experience applying risk management strategies to identify and mitigate study execution challenges.

Strong analytical thinking and ability to resolve complex operational issues.

Excellent communication, presentation, and interpersonal skills when working with project teams, clients, and clinical sites.

Strong conflict resolution and stakeholder management abilities.

Good computer skills and ability to work with clinical trial management systems and digital tools.

Ability to manage multiple priorities while maintaining quality and compliance standards.

Moderate travel availability may be required (approximately 20%).

Benefits:

Opportunity to contribute to global clinical research programs that improve patient outcomes.

Work within a collaborative international environment with experienced healthcare professionals.

Career development opportunities through technical training, therapeutic education, and progression pathways.

Supportive management culture focused on employee growth and recognition.

Exposure to innovative technologies, clinical data solutions, and advanced research methodologies.

Inclusive workplace culture that values diverse perspectives and collaboration.

Remote work flexibility within approved locations.

Comprehensive rewards and benefits programs aligned with employee needs.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether? 

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