Associate Laboratory Project Set-up Manager (REMOTE)
Location: Atlanta, Georgia
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.
- Full Time
- Level: Mid-level
- Travel: No
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.
- Problem solver
- Relationship building
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.
Laboratory Project Set-Up Coordinator
Senior Laboratory Project Set-Up Coordinator
Associate Laboratory Project Set-Up Manager
Laboratory Project Set-Up Manager
Senior Laboratory Project Set-Up Manager
“I know Q2 Solutions offers me a great career path with lots of options. My line manager fully supports my growth.”Marianne H., Associate Laboratory Project Set-Up Manager
A career at Q2 Solutions will provide...
Resources that promote your career growth
Work culture that supports improved work-life balance
Dynamic work enviroment that exposes you to new experiences
Clear pathways to success
Cross-functional idea sharing and thinking to accomplish common goals
Associate Laboratory Project Set-up Manager (REMOTE)
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.
- 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.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- 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
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- 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
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. https://www.q2labsolutions.com/careers
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe
As the COVID-19 virus continues to evolve, Q² Solutions' ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status
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