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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.

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
• 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 learn sessions and create a recommendations report in order to identify successful and unsuccessful project elements, when applicable
• Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.

Qualifications

• Bachelor's Degree Science or related field Pref
• Other Equivalent combination of education, training and experience may be accepted in lieu of degree. Req
• Minimum 2 years of clinical or research industry experience, including 1 year project management / project set up experience Pref Or
• Equivalent combination of education, training and experience Req
• Possess strong interpersonal skills.
• Demonstrated ability to meet deadlines.
• Some experience in leading Phase I-IV clinical trials would be advantageous. Some technical and therapeutic expertise would be advantageous, in addition to significant experience with key customers.
• Demonstrated computer proficiency with Microsoft Office. 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 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.

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.