Associate Laboratory Project Services Manager (Remote)

Job Overview

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.

Responsibilities

• 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
• Meetings, Initiatives and Training Activities:
• Will establish regular lines of communication with sites to manage on-going project expectations and issues.
• Will represent the company at Investigator meetings and other internal / external face to face meetings.
• Will serve as an escalation point for study level issues and will coordinate and triage study-specific issues.
• Study Setup and Planning:
• Will assist in training of less experienced staff.
• Will provide study training to sites, CRAs and customers.
• Study Activity Monitoring and Closeout:
• 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:
• Support development of Customer standards.
• Build and own the Customer relationship, facilitate communication, collaborate with all operational areas within the company.
• Will participate in audits and inspections as required.
• May participate in the proposal and business development process including bid defence meetings.
• Will participate in improvement projects as needed.
• Will monitor the Project Management Plan, timeliness, 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
• Coordinates customer survey follow up and ongoing health checks to support Customer relationship building.
• Facilitate seamless study set-up including Protocol and Budget review, leading meetings, develop and implement project plans, milestone, risk, issue, and action logs.

Required Knowledge, Skills, And Abilities

• Working 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.) preferred.
• Demonstrated computer proficiency with Microsoft Office and the company systems, or equivalent experience with similar Centralized Laboratory systems preferred.
• Strong interpersonal and customer management skills.
• 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.
• 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.
• Ability to establish and maintain effective working relationships with coworkers, managers, and customers.
• Working understanding of medical and clinical research terminology.

Minimum Required Education And Experience

• Bachelor's Degree Life Sciences and/or related field preferred or other equivalent combination of education, training and experience may be accepted in lieu of degree.
• 2+ years of clinical or research industry experience, including 1 year project management / project set up experience preferred or equivalent combination of education, training, and experience.

Q² Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. https://www.q2labsolutions.com/careers

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe

As the COVID-19 virus continues to evolve, Q² Solutions' ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status