Senior Clinical Trial Manager

This is a fully remote position, open to applicants in Australia, +1 more country.

📋 Description

• Lead the execution of activities related to clinical study site management by coordinating clinical staff on intricate studies.

• Ensure compliance with study protocols and plans during site qualification, initiation, interim monitoring, site management, and study closure activities.

• Provide guidance and direction to members of the clinical site management team from the beginning to the conclusion of studies.

• Oversee regional Clinical Trial Managers (CTMs) and harmonize efforts across the CTM team.

• Represent Site Management concerns at meetings with sponsors, investigators, and during bid defenses.

• Contribute to project plans and develop comprehensive global monitoring strategies.

• Offer insights to project tracking systems, financial performance reports, study metrics, resource allocation, and time management.

• Collaborate effectively with teams in Business Development, Regulatory Affairs, Study Start-up, and Project Management.

• Assume a dual role as Project Manager/CTM when necessary.

• Create, maintain, and ensure adherence to Clinical Monitoring Plans, budgets, study tools, and site visit reports.

• Train and supervise Clinical Research Associate (CRA) teams on the clinical dimensions of studies.

• Develop and execute recruitment strategies while monitoring enrollment progress.

• Enhance site data quality by reviewing data metrics and addressing issues with actionable plans.

• Analyze data trends and trip report concerns and escalate issues as necessary.

• Ensure compliance with the Trial Master File (TMF) and readiness for inspections.

• Anticipate site visit requirements and address staffing needs and backlogs.

• Establish performance expectations and mentor or coach colleagues and clinical project staff.

• Conduct co-monitoring and site visits as needed.

• Assist during inspections by health authorities and sponsor audits.

• Actively identify and mitigate potential risks.

• Perform additional duties as assigned.

⛳️ Requirements

• Bachelor's degree or equivalent in biological, physical, or health studies, with at least four years of experience as a Senior Clinical Research Associate (or equivalent).

• OR an associate degree or equivalent education/training with a minimum of six years as a Senior Clinical Research Associate.

• At least 2 years of relevant experience as a CTM/LCRA (or equivalent), including supervising a CTM team.

• Willingness to travel is required.

• A valid current passport is mandatory.

• A driving license is necessary.

• Excellent verbal and written communication skills in English.

• Strong understanding of FDA and/or EU Directive regulations, ICH Guidelines, and local regulatory requirements.

• Proficient in Microsoft Office, eCRF, and IVRS software.

• Skilled in IxRS, CTMS, and EDC systems.

• Comprehensive understanding of clinical research principles and processes.

• Experience and knowledge of therapeutic areas sufficient to operate effectively as a CTM.

• In-depth knowledge of standard operating procedures.

• Exceptional planning, organizational, interpersonal, and presentation skills.

• Capability to lead and inspire teams remotely across different time zones.

🏝️ Benefits

• An inclusive and diverse work environment.

• Supportive and collaborative teams.

• Accessibility to leadership.

• Equal employment opportunities for all.

• Opportunities for mentoring and coaching.