Assoc Lab Project Set-Up Manager, Q2 Solutions
Buenos Aires, Argentina
- Full Time
- Level: Entry-level, Mid-level, Senior-level
As a member of our global Set-Up team, you will play a vital role in the design and launch of clinical trials, collaborating with cross-functional colleagues around the world to exceed expectations. From your first day at Q2 Solutions, you will have a chance to cultivate the behaviors, knowledge and skills needed for you to be successful. You will have the opportunity to grow and develop your career, while partnering with top pharmaceutical companies, CROs, specialty, local and third-party labs and medical device manufacturers on complex clinical trials.
Success profile
What makes employees on our Set-Up team successful? Check out the top traits we’re looking for and see if you have the right mix.
- COLLABORATIVE
- COMMUNICATOR
- LEADERSHIP
- STRATEGIC
- PROBLEM SOLVER
- RELATIONSHIP BUILDING
Explore this career path
As you progress through your career at Q2 Solutions, you'll play an important part in helping our customers drive healthcare forward and ultimately improving health outcomes for patients.
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Laboratory
project set-up
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Senior
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project set-up
coordinator -
Associate
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project set-up
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Laboratory
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Senior
laboratory
project set-up
manager
A career at Q2 Solutions will provide
Assoc Lab Project Set-Up Manager, Q2 Solutions
Job description
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.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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