Senior Clinical Trials Manager
1 month ago
Company Overview
Allucent is a leading provider of clinical trial services, dedicated to helping small-medium biopharmaceutical companies navigate the complex world of clinical trials.
We are looking for a seasoned professional to join our team as a Sr. Clinical Trial Leader.
About the Role
This is an exciting opportunity to work with a talented team of professionals who share your passion for delivering high-quality clinical trials results.
The successful candidate will be responsible for providing leadership and management to the Clinical Research Associates (CRAs) and other clinical functional groups, in their day-to-day clinical trial activities.
Main Responsibilities
- Manage the study start-up process in collaboration with the Project Manager, Regulatory Lead, and Global Site Activation Manager.
- Coordinate and oversee critical documentation collection, maintenance, and filing.
- Prepare monitoring plans, provide input to TMF plans, and ensure all plans are implemented.
- Contribute to the development of CRF guidelines and edit checks.
- Customize site visit report checklists/templates and their annotated versions according to study-specific requirements.
- Develop or modify templates for monitoring activities according to study requirements.
- Select investigators and sites; review and approve SEV reports.
- Manage site initiation and SIV report reviews and approvals.
- Review, manage, resolve, and escalate monitoring visit reports (MVRs).
- Ensure timely and efficient trial close-out, identify critical activities, and manage successful trial closure.
- Responsible for timelines, budget, and quality of Clinical Monitoring team deliverables, identifying risks and issues, and escalating to PM, 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 PM for regular Project Review Meetings and attend meetings if needed.
- Conduct project co-monitoring (if required) and team training.
- Act as a site contact for protocol clarifications and subject enrollment if CRAs are 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 and ensure proactive re-training with CRAs and site staff.
- Oversee the process of protocol deviation documentation, tracking, and escalation.
- Participate in the development of study newsletters communication.
- Relay project status and issues to PM.
- Request appropriate Clinical Operations staffing, workload, and resources through the PM.
- Assist the PM in discussions with clients on study documentation issues or technical-related documentation concerns.
- Review study systems updates on a regular basis, ensure system reports are up-to-date, and generated reports are current and correct.
- Coach/mentor CRAs.
- Develop and deliver project-specific training and provide input to Project-Specific Training Matrix.
- Ensure project consistency within and across projects by following SOPs.
- Assist in the preparation of study-specific training matrix and various training material, including SOPs training and specific-therapeutic area-related material.
Requirements
To be successful, you will possess:
- 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 supports the 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.
Estimated Salary: $120,000 - $180,000 per annum, depending on experience and location. Benefits include comprehensive benefits package, competitive salaries, departmental study/training budget, flexible working hours, remote/hybrid* working opportunities, leadership and mentoring opportunities, participation in our enriching Buddy Program, internal growth opportunities, career progression, financially rewarding employee referral program, access to online soft-skills and technical training via GoodHabitz, eligibility for Spot Bonus Award Program, and Loyalty Award Program.
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