Associate Lab Project Set-Up Manager (Office or Home Based, Marietta, GA)
Launched in 2015, Q2 Solutions is a leading global clinical trials laboratory services organization. We help biopharmaceutical, medical device and diagnostics customers improve human health through innovation that transforms science and data into actionable medical insights. Q2 Solutions is a quality driven, responsive partner with strong global experience and deep scientific and medical expertise. The Q2 Solutions joint venture was formed by Quintiles and Quest Diagnostics, combining the best of each parent organizations clinical trials laboratory services capabilities.
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.
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.
- Perform database configuration and programming review and approve verification unit testing while adhering to the database design requirements.
- Collaborate with senior colleagues during planning 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 updates to the project tracking database, action/issues logs, status sheets and timelines during the set up phase.
- Communicate and coordinate set-up activities with clients and internal customers to ensure approvals are met, launch is successful, and a seamless transfer of the project to the Project Manager.
- 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. Provide additional training to sponsor, CRO, and site personnel as required (telephone training, attendance at CRA training meetings, site refresher meetings, etc.).
- Participate in external and internal audits as required.
- Coordinate and mentor more junior staff; may assist in training new staff on assigned to projects.
- Report on team performance against contract, customer expectations, and project baselines to management.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Possess strong interpersonal skills for interaction with senior members within sponsor organizations
- Demonstrated ability to meet deadlines.
- Demonstrated computer proficiency with Microsoft Office and Quintiles LIMS system. .
- 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.
- Previous knowledge of Quintiles Laboratories processes and computer systems is highly desired.
- Good organizational and operational skills
- Good accuracy and attention to detail skills
- Strong written and verbal communication skills including good command of English language
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree in science related field and 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
EEO Minorities/Females/Protected Veterans/Disabled
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