Clinical Trials Manager

2 weeks ago


Melbourne, Victoria, Australia Allucent Full time
Job Title: Senior Clinical Trial Leader

We are seeking a highly experienced Senior Clinical Trial Leader to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and management to our Clinical Research Associates (CRAs) and other clinical functional groups in their day-to-day clinical trial activities.

Key Responsibilities:
  • Manage the study start-up process, including coordination with the Project Manager, Regulatory Lead, and Global Site Activation Manager (GSAM).
  • Oversee the collection, maintenance, and filing of critical documentation.
  • Prepare and implement monitoring plans, TMF plans, and other study plans.
  • Contribute to the development of CRF guidelines and edit checks.
  • Customize site visit report checklists and templates according to study requirements.
  • Develop or modify templates for monitoring activities.
  • Select investigators and sites, review and approve SEV reports.
  • Manage site initiation, review and approve SIV reports.
  • Review, manage, and escalate monitoring visit reports.
  • Ensure successful trial close-out, identify critical activities for timely and efficient close-out.
  • Manage timelines, budget, and quality of clinical monitoring team deliverables.
  • Coordinate and manage site visit schedules.
  • Manage CRA site assignments and schedules.
  • Develop patient recruitment and retention plans.
  • Provide information and input about planned activities to the Project Manager for regular project review meetings.
  • Conduct project co-monitoring and team training.
  • Act as site contact for protocol clarifications and subject enrollment.
  • Monitor and manage trial materials supplies.
  • Review data listings and query reports to identify trends and ensure proactive re-training.
  • Oversee protocol deviation documentation, tracking, and escalation.
  • Participate in the development of study newsletters and communication.
  • Relay project status and issues to the Project Manager.
  • Request clinical operations staffing, workload, and resources through the Project Manager.
  • Assist the Project Manager in discussions with clients on study documentation issues.
  • Review study systems updates, ensure systems reports are up-to-date, and reports generated are current and correct.
  • Coach and mentor CRA team members.
  • Develop and deliver project-specific training and provide input to the project-specific training matrix.
  • Ensure project consistency within and across projects by following SOPs.
  • Assist in the preparation of study-specific training matrices and various training materials.
  • Assist in the preparation of company and scientific/medical presentations to potential clients and at investigators' meetings.
  • Assist in the revision of site budgets and manage investigator and site payments.
  • Contribute to case management and timely closure.
  • Support the Project Manager in the management of study vendors.
  • Provide input into proposals when required.
  • Actively participate in the preparation, attendance, and presentation of bid defense or any other study-related meetings.
Requirements:
  • Bachelor's degree in life sciences or nursing qualification preferred.
  • Minimum of 6 years of clinical research experience with at least 2 years of CTL or CTM experience.
  • Ability to mentor and train other CRAs in a positive and effective manner.
  • In-depth knowledge of clinical trials and critical elements for success in clinical trials.
  • Strong therapeutic background.
  • Possesses experience and knowledge in the CRO industry to support management of clinical trials.
  • Demonstrates ability to successfully manage people/project issues.
  • Mature management skills demonstrated by calm and thorough review of situations.
  • Demonstrates ability to define and meet project requirements.
  • Demonstrates flexibility for improvement and creating solutions.
  • Proven organizational abilities and excellent written and oral communication skills.
  • Excellent team player with team building skills.
  • Strong customer focus.
Benefits:
  • Comprehensive benefits package per location.
  • Competitive salaries per location.
  • Departmental study/training budget for furthering professional development.
  • Flexible working hours (within reason).
  • Opportunity for remote/hybrid working depending on location.
  • Leadership and mentoring opportunities.
  • Participation in our enriching Buddy Program as a new or existing employee.
  • Internal growth opportunities and career progression.
  • Financially rewarding internal employee referral program.
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms.
  • Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects.
  • Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees.


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