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Senior Clinical Research Manager

2 months ago

Adelaide, South Australia Allucent Full time
Senior Clinical Trial Leader Job Description

Allucent is seeking a highly experienced Senior Clinical Trial Leader to join our team.

The ideal candidate will have a strong background in clinical research and a proven track record of managing complex clinical trials. The Senior Clinical Trial Leader will be responsible for providing leadership and management to the Clinical Research Associates and other clinical functional groups, ensuring the successful execution of clinical trials.

Key Responsibilities:

  • Manage the study start-up process, including coordination with the Project Manager, Regulatory Lead, and Global Site Activation Manager.
  • Oversee the critical documentation collection, maintenance, and filing process.
  • Prepare the Monitoring Plan and provide input to the TMF Plan and other study plans.
  • Contribute to the development of CRF guidelines and edit checks.
  • Customize Site Visit Report checklists/templates and annotated versions according to study requirements.
  • Develop or modify templates for monitoring activities according to study requirements.
  • Select investigators and sites, review and approve SEV reports.
  • Manage site initiation, review and approve SIV reports.
  • Review, manage, resolve, and escalate Monitoring Visit Reports.
  • Ensure successful trial close-out, identifying critical activities for timely and efficient close-out.
  • Responsible for timelines, budget, and quality of Clinical Monitoring team deliverables, identifying risks and issues, and escalating to the Project Manager, Line Manager, and CRMs/COMs.
  • 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 and attend Project Review Meetings as needed.
  • Conduct project co-monitoring (if required) and team training.
  • Site contact for protocol clarifications and subject enrollment if CRA unavailable.
  • Monitor and manage trial materials supplies, ensuring Investigational Product and other study supplies are shipped to sites.
  • Review data listings and query reports to identify trends, ensuring proactive re-training with CRAs and site staff.
  • Oversee protocol deviation documentation, tracking, and escalation.
  • Participate in the development of study newsletters communication.
  • Relay project status and issues to the Project Manager.
  • Request through the Project Manager appropriate Clinical Operations staffing, workload, and resources, reporting study deliverables and resource needs.
  • Assist the Project Manager in discussions with clients on study documentation issues or technical-related documentation concerns.
  • Review study systems (CTMS, CRF, IRS, central lab portal, etc.) updates on a regular basis, ensuring systems reports are up-to-date and reports generated are current and correct.
  • Coach/mentor CRA team members.
  • Develop and deliver project-specific training, providing input to the Project-Specific Training Matrix.
  • Ensure project consistency within and across projects by following SOPs.
  • Assist and support in the preparation of study-specific training matrices and various training materials, including SOPs training and specific-therapeutic area-related materials.
  • Assist in revising site budgets and managing Investigator and Site Payments.
  • Contribute to case management and timely closure.
  • Support the Project Manager in managing study vendors as required.
  • Provide input into proposals as required.
  • Actively participate in preparation, attendance, and presentation of bid defense or any other study-related meetings.

Requirements:

  • A bachelor's degree in life sciences or nursing qualification preferred.
  • A 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 the critical elements for success in clinical trials.
  • Strong therapeutic background.
  • Possesses experience and knowledge in the CRO industry that will support management of clinical trials.
  • Demonstrates the ability to successfully manage people/project issues.
  • Mature management skills demonstrated by calm and thorough review of situations, proactively identifying and addressing problems, seeking to understand all contributing factors, proposing, implementing, and evaluating appropriate resolutions.
  • Demonstrates the 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.