Associate Lab Project Set-Up Manager

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.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

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.  Roll encompasses Set Up Managers and Associate Set Up Managers.

Essential Functions
• 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.
• 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 providing updates to the Project Manager regarding action/issues logs, status sheets and timelines during the start-up 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 and Bid Defense 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.
• Lead in the development of sponsor specific standards and program-specific set-up procedures.
• Participate in improvement projects as defined by the relevant process improvement management team.
• Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.

Qualifications
• Bachelor's Degree Science related background is advantageous but is not essential Req
• 3 years of clinical or research industry experience, including 1 year project management experience Req Or
• Equivalent combination of education, training and experience Req
• Possess strong interpersonal skills
• Demonstrated ability to meet deadlines.
• Demonstrated computer proficiency with Microsoft Office
• Experience in successfully leading Phase I-IV clinical trials.
• Demonstrated technical and therapeutic expertise, in addition to significant experience with key customers.
• Working knowledge of Clinical Trials Management Systems would be an advantage.
• Possess an understanding of medical and clinical research terminology.
• Demonstrated ability to work in a fast-paced, high stress environment.
• 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.