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. Will 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. Will lead in the development of Customer standards. Will lead Customer meetings / presentations in partnership with Senior Project Services / Operational / Business Development staff
- With experience may perform technical review at program / project initiation. Will manage more complex studies (e.g. Companion Diagnostic, multiple region studies)
- Study Activity Monitoring and Closeout:
- Will 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
- Will 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. Will 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
- Will lead activities that enhance Customer Delivery Team results and strengthen Customer Governance. Serve as an escalation point for program level issues
- Meetings, Initiatives and Training Activities:
- Will represent the company at Investigator meetings and other internal / external face to face meetings. Will participate in audits and inspections as required
- Will provide study training to sites, CRAs and customers. Will establish regular lines of communication with sites to manage on-going project expectations and issues
- Will participate in improvement projects as needed. With experience will direct, mentor and assist in training
- Will provide feedback on team performance against contract, customer expectation and project plan to management. May act as a Program Lead
• Process Improvements and Special Assignments: May take the lead as task owner or Subject Matter Expert. Will assist with department level assignments as required
• Program Lead: Responsible for the assigned global customer program(s), including development of operational processes and high-quality delivery and customer satisfaction. Act as process owner for customer program(s) in areas including but not limited to, Customer Specific Training, SOPs, and process improvements
Qualifications
- Bachelor's Degree Life Sciences or related field or other equivalent combination of education, training and experience may be accepted in lieu of degree.
- 5+ years of clinical or research industry experience, including 3 years project management / project set up experience
- Excellent interpersonal and customer management skills.
- Thorough understanding of medical and clinical research terminology.
- Thorough knowledge of Project Management processes, the company laboratory processes, and/or equivalent working knowledge of central laboratory operations (kits/supplies, logistics, laboratory operations, specimen storage, data reporting and transfers, site alerts, etc.) required.
- Demonstrated computer proficiency with Microsoft Office and the company systems, or equivalent experience with similar Centralized Laboratory systems preferred.
- Experience in successfully leading large, global and complex 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. In certain geographies where communication in local language is desired (e.g. Japan, China), excellent command of local language with reasonable proficiency in English preferred.
- Ability to establish and maintain effective working relationships with coworkers, managers and customers.
