Description
Under general direction, manage all laboratory aspects of assigned clinical trial projects for a Customer or a specific program for a Customer. May have responsibility for a specific Customer, drug program, indication or drug compound. Acts as the main point of contact for the Customer after study award and throughout the entire study lifecycle (startup, maintenance, closeout). Ensures work is conducted in line with standard operating procedures, policies and good practices.
Essential Functions
- Study Setup and Planning: Facilitate seamless study set-up including Protocol and Budget review, leading meetings, develop and implement project plans, milestone, risk, issue and action logs. Partner with Study Setup team to ensure quality database set-up, oversee preparation of protocol specific documentation. Prepare and present protocol-specific materials at Kick Off and Investigator meetings.
- May participate in the proposal and business development process including bid defence meetings. Support development of Customer standards.
- Study Activity Monitoring and Closeout: Monitor the Project Management Plan, timelines and deliverables, manage study documentation throughout the Project lifecycle including filing into eTMF, oversee study monitoring and reporting, conduct meetings to meet needs of the Study and Customer requirements.
- Manage study scope changes and budget, monitor quality of the study and any service-related issues, implementing changes as required. Lessons learnt will be reviewed and shared.
- Proactive Lines of Communication: Build and own the Customer relationship, facilitate communication, collaborate with all operational areas within the company.
- Serve as an escalation point for study level issues and will coordinate and triage study-specific issues.
- Coordinates customer survey follow up and ongoing health checks to support Customer relationship building.
- Meetings, Initiatives and Training Activities: Represent the company at Investigator meetings and other internal / external face to face meetings. Participate in audits and inspections as required.
- Provide study training to sites, CRAs and customers.
- Establish regular lines of communication with sites to manage on-going project expectations and issues. Participate in improvement projects as needed.
- Assist in training of less experienced staff.
Qualifications
- Bachelor's Degree Life Sciences and/or related field preferred.
- 2+ years of clinical or research industry experience, including 1 year project management / project set up experience preferred.
- Strong interpersonal and customer management skills.
- Working understanding of medical and clinical research terminology.
- Working knowledge of Project Management processes, the company's laboratory processes, and/or equivalent working knowledge of central laboratory operations preferred.
- Demonstrated computer proficiency with Microsoft Office and the company's systems, or equivalent experience with similar Centralized Laboratory systems preferred.
- Experience in successfully leading Phase I-IV clinical trials preferred.
- Demonstrated ability to work in a fast-paced environment while possessing strong organizational skills and a demonstrated ability to meet deadlines.
- Strong written and verbal communication skills including good command of English language.