Clinical Trials Manager
Há 7 dias
We are seeking a highly skilled and experienced Clinical Trials Manager to join our team at Allucent. As a Clinical Trials Manager, 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- Coordinate and manage CRA activities across all geographies
- Liaise with sponsors and project managers to ensure clinical monitoring deliverables are met
- Manage trial start-up and site activation
- Oversight of critical documentation collection, maintenance, and filing
- Develop monitoring plans and site monitoring templates and tools
- Review trial-specific documents and develop subject-facing materials
- Customize annotated site visit reports
- Selection of investigators and sites
- Site initiation management
- Monitoring visit report review and management
- Successful trial close-out
- Responsible for timelines, budget, and quality of clinical monitoring team deliverables
- Provides information and input about planned activities and status to project managers
- Conducts project co-monitoring and site management/monitoring as needed
- Coaches and mentors CRA team members
- Prepares and chairs CRA calls and participates in internal trial team calls and client calls
- Oversees CRA handovers and serves as a site contact for protocol clarifications and subject enrollment
- Monitors and manages trial materials supplies
- Reviews data listings and query reports
- Oversees protocol deviation and trial non-compliance documentation, tracking, and escalation
- Participates in the development of trial newsletters and communications
- Requests clinical operations staffing, workload, and resources
- Assists project managers in discussions with clients on trial documentation issues
- Reviews trial systems and updates on a regular basis
- Ensures project consistency within and across projects
- Assists in the preparation of various training materials
- Prepares country-level site-facing budgets and manages investigator and site payments
- Supports project managers in the management of trial vendors
- Project contract awareness and oversight
- Provides input into proposals and actively participates in the preparation and attendance of bid defenses
- A degree in life sciences or nursing qualification preferred, but not required
- A minimum of 5 years of clinical research experience, including a combination of SCRA and CTL/CTM, PM, or regulatory/auditing experience
- In-depth knowledge of ICH GCP, clinical trials, and the critical elements for success in clinical trials
- Strong therapeutic background
- Experience and knowledge in the CRO industry that will support Allucent's management of clinical trials
- Strong written and verbal communication skills, including good command of the English language
- Professional and strong client-focused
- Ability to work in a fast-paced, challenging environment of a growing company
- Administrative excellence with attention to detail and accuracy
- Leadership and mentoring skills with the ability to mentor and train other CRAs
- Excellent team player with team building skills
- Strong organizational skills to manage a full workload across multiple projects
- Demonstrates flexibility for creating solutions and process improvement
- Analytical, financial, and problem resolution skills
- Proficiency with various computer applications, including Word, Excel, and PowerPoint, CTMS, eTMF
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