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.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. PURPOSE
Under general supervision, manage the process of designing and launching single region, less-complex global/regional clinical research studies under general direction; lead activities of the Sponsor/Clinical Research Organization (CRO), and guide the Project Manager (PM) and Set-up Coordinators (SC) in designing and organizing project components during Start-Up.RESPONSIBILITIES
- Develop the database design requirements which include configuration (project specific kit contents, laboratory events, requisitions, medical reports), programming for full protocols and protocol amendments, and developing and maintaining client design standards as applicable in accordance with the requirements of the Clinical Protocol.
- Perform database configuration and programming review and approve verification unit testing
- Collaborate with colleagues during planning & handover meetings regarding project timelines, and project-related issues focusing on capabilities within 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.
- Communicate and coordinate set-up activities with clients and internal customers to ensure that all milestones are achieved.
- Lead in the development of sponsor specific standards and program-specific set-up procedures.
- Lead in the identification and resolution of service level issues and where issues affect other projects within and across programs to ensure that any solution is employed universally.
- Ensure lessons learned are considered, shared and improvements included in study design process. Oversee the writing of protocol-specific laboratory instruction manuals / participate in the preparation and maintenance of the laboratory specifications document for each protocol within a program as appropriate.
- 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.
- Coordinate and mentor more junior staff; may assist in training new staff.
- Report on team performance against contract, customer expectations, and project baselines to management.
- Possess strong interpersonal skills
- Demonstrated ability to meet deadlines.
- Demonstrated computer proficiency with Microsoft Office
- Working knowledge of Clinical Trials Management Systems would be an advantage [examples QLIMs, NewLIMs, TOPCAT, Encompass].
- 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
- Strong written and verbal communication skills written & spoken, influencing & negotiating
- Excellent inter-personal skills
- Bachelor's degree or equivalent education and experience; science related background is advantageous but is not essential
- Minimum 3 years of clinical or research industry experience, including 1 year project management experience; or equivalent combination of education, training and experience
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of fingers
- Regular sitting for extended periods of time
- May require occasional travel
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