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Laboratory Project Set-Up Manager (Remote)

Company

Novasyte
Address , Atlanta, Ga
Employment type FULL_TIME
Salary
Expires 2023-10-01
Posted at 9 months ago
Job Description
JOB OVERVIEW
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
  • Communicate and coordinate set-up activities with clients and internal customers to ensure that all milestones are achieved.
  • 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.
  • Coordinate and mentor more junior staff; may assist in training new staff.
  • 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.
  • 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.
  • Perform database configuration and programming review and approve verification unit testing
  • Participate in external and internal audits as required.
  • 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.
  • Report on team performance against contract, customer expectations, and project baselines to management.
  • As required, prepare and present study-specific materials and services at Investigator, Kick-off and Bid Defense meetings.
  • Lead in the development of sponsor specific standards and program-specific set-up procedures.
  • Responsible for providing updates to the Project Manager regarding action/issues logs, status sheets and timelines during the start-up phase.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
  • Demonstrated ability to work in a fast-paced, high stress environment.
  • Excellent inter-personal skills
  • Knowledge of Project Management processes and terminology.
  • Demonstrated ability to meet deadlines.
  • Demonstrated computer proficiency with Microsoft Office
  • Excellent organizational and time management skills
  • Strong written and verbal communication skills written & spoken, influencing & negotiating
  • Excellent accuracy and attention to detail skills
  • Possess an understanding of medical and clinical research terminology.
  • Possess strong interpersonal skills
  • Working knowledge of Clinical Trials Management Systems would be an advantage [examples QLIMs, NewLIMs, TOPCAT, Encompass].
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
  • Minimum 3 years of clinical or research industry experience, including 1 year project management experience; or equivalent combination of education, training and experience
  • Bachelor's degree or equivalent education and experience; science related background is advantageous but is not essential
PHYSICAL REQUIREMENTS
  • May require occasional travel
  • Regular sitting for extended periods of time
  • Extensive use of keyboard requiring repetitive motion of fingers
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech
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