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.
With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.
Provide day-to-day direction of staff and manage the Client Delivery Team to achieve client and company goals and / or initiatives;
Support direct reports and drive continuous improvement in processes and procedures used by the project team; Perform duties and responsibilities of Project Manager / Set Up Project Manager when needed, for short-term or long-term assignments.
This position involves extensive mentoring and professional development of direct staff within the Customer Delivery Teams :
Manage assigned staff and day-to-day activities in accordance with organizational policies and applicable regulations
Responsibilities include planning, assigning, and directing work
mentoring and training staff
performance management, including appraising performance and guiding professional development, rewarding and disciplining employees as applicable
Continuous assessment of talent within project management and drive consistent, high-quality project management services
Develop and encourage a culture of delivering best-in-industry customer service by ensuring rapid identification of issues and problems and ensuring timely communication of resolution outcomes to both internal and external customers
Ensure that studies are planned and executed in accordance with FDA, ICH, and / or EMEA guidelines and that Good Clinical Practices are followed at all times
Report metrics to Associate Director related to productivity and quality
Act as a champion or business process owner as appropriate to ensure that Six Sigma or other projects are completed as described in the project charter and within the timelines agreed by company management
Participate in initiatives to improve employee engagement to positively impact operational results, customer satisfaction and employee retention
Actively participate or lead external customer meetings with sales as applicable
Participate in bid defense meetings to drive new and repeat business
Serve as liaison between Project Services, internal departments, external vendors and the sponsor during the life cycle of the project(s)
Foster a unified culture and facilitate collaboration, co-operation, sharing of information and teamwork
Build and own client relationship for assigned study and serve as a liaison between Sponsor and project teams
Lead communications and activities that further enhance the Client Delivery Team results and further strengthen the Client Governance structure
Initiate and manage appropriate customer health check calls for staff as applicable
Represent the company at Investigator / Monitor meetings, internal and external authorities of regulatory bodies, and other Face to face meetings as needed
Participate in external and internal audits / inspections, as required
As needed, administer study training to sites, CRA and sponsors and establish regular lines of communication with sites to manage on-going project expectations and issues
Report on team performance against contract, client expectations, and project baselines to management
Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice
Bachelor's Degree Life Sciences and / or related field Req
Minimum 4 years of experience in clinical trials / hospital-funded research, project management or laboratory environment.
Strong people management skills with the ability to develop and lead cross-functional teams
Excellent interpersonal, organizational and client management skills Direct line management experience preferred
Strong knowledge of Project Services processes, the company laboratory processes, and / or equivalent working knowledge of central laboratory operations preferred.
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 while possessing strong organizational skills and an ability to meet deadlines
Strong written / verbal communication skills including good command of the English language. In certain geographies where 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 clients.