Senior Laboratory Project Set Up Manager (Homebased)

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. 

Job Overview
Manage the process of designing and launching clinical research studies; Manage activities of the Sponsor/Clinical Research Organization (CRO); Lead colleagues in the design and organization of project components during Start-Up; Develop and maintain best practices within the organization; Accountability and ownership for the quality of all start-up work and sponsor deliverables; Support Business Development and commercial activities to help develop business growth.

RESPONSIBILITIES 
• Develop the database design requirements which include configuration definition for full protocols, protocol amendments and sponsor study changes
• developing and maintaining client design standards as applicable in accordance with the Clinical Protocol
• Manage study database configuration
• Support internal/external stakeholders in the development of sponsor standards and as a Set-up point of contact
• Collaborate with colleagues during planning meetings regarding project timelines, and project-related issues focusing on capabilities within, but not limited to, Data Management, Logistics, Clinical Trial Materials, Laboratory Testing, and Specimen Management
• Responsible for updates to the project, including the action/issues logs, status sheets and timelines during the startup phase, where applicable
• Communicate and coordinate set-up activities with clients and internal customers to ensure that all milestones are achieved
• Proactively manage changes in study related project scope, identify potential risks, and devise contingency plans
• As required, prepare and present study-specific materials and services at Investigator, Kick-off meetings. Participate in external and internal audits as required
• Provide day to day guidance to more junior staff assigned to project or within a specific program area
• may act as a mentor as well as assist in the training and development of more junior staff
• Participate in improvement projects as defined by the relevant process improvement management team
• Conduct project lesson learned sessions and create a recommendations report in order to identify successful and unsuccessful project elements, when applicable
• Ability to manage higher complexity studies involving elaborate database configuration. . Lead in the development of sponsor specific standards and program-specific set-up procedures
• May act as a Program Lead for specific Customer study programs
• Participate and/or provide materials and information for Bid Defense meetings
• Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Bachelor's Degree Science related background is advantageous but is not essential
• Minimum 4 years of clinical or research industry experience, including 1 year project management experience. Equivalent combination of education, training and experience.

REQUIRED KNOWLEDGE,SKILLS,AND ABILITIES

• Possess strong leadership and interpersonal skills.
• Demonstrated ability to meet deadlines.
• Experience in successfully leading Phase I-IV clinical trials.
• Demonstrated technical and therapeutic expertise, in addition to significant experience with key customers.
• Demonstrated computer proficiency with Microsoft Office.
• Experience of working with Clinical Trials Management Systems
• Possess an understanding of medical and clinical research terminology.
• Knowledge of Project Management processes and terminology.
• Excellent organizational and time management skills.
• Excellent accuracy and attention to detail skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.