Clinical Trials Manager
2 weeks ago
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.
- 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.
- 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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