Full-Time Clinical Research Manager

The Clinical Research Manager leads clinical operations in coordinating and implementing clinical IDE-FDA studies, Investigator Initiated studies, and Registries.

Responsibilities Include:

• Implementing and managing Sirtex Technology clinical research activities.
• Developing project plans, timelines, milestones, budgets, and staffing.
• Collaborating with Medical Affairs, Commercial, Health Economics, Biostatisticians, Quality, Regulatory Affairs, Investigators, and research organizations.
• Managing and developing regional clinical research staff, CROs, and investigational sites.
• Developing, implementing, and maintaining departmental policies and procedures to ensure GCP compliance.
• Coordinating study contracts and budgets with sites and investigators.
• Creating and managing internal study plans and timelines.
• Providing training and leadership to clinical research staff, CROs, CRAs, and sites.
• Conducting initiation, site selection, monitoring, and close-out visits; organizing meetings.
• Tracking study progress and ensuring data integrity.
• Ensuring monitoring visit reports, documentation, and contracts are complete.
• Assessing clinical trial vendors and supporting vendor selection and contracting.
• Overseeing vendor operations and financial budgets.
• Tracking payments to sites and vendors.
• Acting as a liaison between departments, sites, and vendors.
• Ensuring administrative duties are completed.
• Ensuring regulatory compliance with SOPs, QWIs, national/international regulations (e.g., EU Directives, ISO 14155).
• Collaborating with the Study Management Team and Health Economics on study protocols.
• Preparing study documentation (e.g., Informed Consent Forms, CRFs).
• Developing relationships with investigators and site staff.
• Collaborating with the regional clinical team to manage budgets.
• Reviewing clinical invoices and forwarding for approval.
• Ensuring all clinical studies comply with ICH GCP guidelines/regulations.
• Participating in quality assurance activities, including audits.
• Reviewing monitoring reports and resolving site issues.
• Coordinating regulatory or ethics committee activities.
• Coaching, mentoring, and guiding junior staff.

Qualifications:

• Bachelor's degree; Master's preferred.
• 6-8 years' clinical study experience with on-site management responsibility.
• 4 years' monitoring experience in pharmaceutical/medical device/biotechnology or CRO companies.
• Understanding of ISO 14155 and ICH GCP guidelines.
• Strong clinical study management, communication, organizational, problem-solving, conflict resolution, leadership, and teamwork skills.

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