Clinical Trial Manager

This is a fully remote position, open to applicants in Australia.

📋 Description

• Develop the Site Activation Plan and tailor study start-up documents.

• Coordinate the identification, selection, and recruitment of sites.

• Supervise the collection, review, and submission of regulatory documents and ethics applications.

• Prepare and assess essential study documentation.

• Authorize the release of Investigational Products.

• Coordinate site contracts and manage budget negotiations.

• Oversee clinical deliverables, project milestones, timelines, and address deficiencies.

• Train, delegate tasks, and supervise CRAs and other members of the study team.

• Develop Monitoring Plans, tools, and training resources.

• Manage the scheduling of monitoring visits and evaluate CRA performance.

• Review and approve visit reports, follow-up letters, expenses, and timesheets.

• Conduct remote clinical data reviews in EDC systems and identify trends in enrollment and data entry.

• Perform quality-control reviews of the Trial Master File (TMF) and ensure proper filing of regulatory documents.

• Manage budgets, contracts, deliverables, and quality of clinical vendors.

• Assist with study budgets, expenses, revenue recognition, scope adjustments, and invoice reviews.

• Monitor assigned sites and support on-site audits.

• Participate in and contribute to investigator meetings, kick-off meetings, client meetings, and project discussions.

⛳️ Requirements

• Exceptional written and verbal communication, presentation abilities, conflict resolution, time management, organizational, interpersonal, and problem-solving skills.

• Understanding of project management techniques and tools, with proficiency in project management software.

• Strong skills in team-building and the ability to thrive in a matrixed team environment.

• Excellent customer service and relationship-building capabilities.

• Comprehensive working knowledge of ICH, GCP, and local guidelines/regulations.

• Familiarity with all aspects of clinical trial execution, including systems, study financials, and procedures.

• Ability to prioritize and manage multiple responsibilities and delegate tasks as needed.

• Commitment to quality in all work tasks and deliverables.

• Proficient in computer systems, applications, and operating systems.

• Degree in Life Sciences, nursing background, or a combination of education and experience.

• At least three years of experience in clinical trial management.

• Previous experience in personnel management is preferred.

• Prior experience as a CRA is preferred.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health benefits including medical, dental, and vision.

• Opportunities for professional development and career growth.

• Flexible working hours and remote work options.

• Supportive and collaborative work environment.