IQVIA Senior Laboratory Project Services Coordinator in Marietta, Georgia
Provide project related support by assisting in the design and launch of small, regional projects or global projects with low complexity; ensure project databases are set up according standard operating procedures, policies and good practice;
Assist in the development of database design requirements, including configuration (e.g. project specific kit contents, laboratory events, requisitions, medical reports) and programming for full protocols and protocol amendments.
Conduct configuration and programming reviews; lead in database verifications while adhering to database design requirements.
Contribute to project planning, such as creating accurate project timelines, complying with regulatory steps, and identifying potential project related issues.
Lead set-up activities and communications with client and or Sponsor counterparts, assist project coordinators in resolving queries and identify and escalate issues as required.
With supervision, mange the entire set-up process for a one region, low complexity study with the oversight of a project manager.
Coordinate set-up activities across data management, logistics, clinical trial materials, laboratory testing, and specimen management.
Create and maintain project set-up updates to project tracking database, actions/issues log, and status sheets
Use knowledge of protocol specific and routine tasks to ensure outputs are delivered in line with organizational standards and client expectations.
Coordinate information and communications for set-up activities with clients and internal customers to ensure approvals are met, launch is successful and a smooth, event free, handover to project services colleagues.
Perform technical reviews and feedback comments and changes to project managers.
Contribute to process improvement initiatives.
Maintain accurate project documentation.
Mentor and assist in training more junior staff,
May host Project Launch meetings or other internal meetings on behalf of Project / Set Up Manager.
May provide back-up support on behalf of colleagues who are absent from the office.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Requires protocol specific knowledge
Good organizational and operational skills
Good accuracy and attention to detail skills
Strong written and verbal communication skills including good command of English language
Computer proficiency in word processing, presentation, and spreadsheet applications
Demonstrated ability to work in a fast-paced, high stress environment highly desirable Ability to work with limited support through complex global trials
Ability to establish and maintain effective working relationships with co-workers, managers and clients.
Knowledge of Quintiles or Quest Laboratories processes and computer systems (including TOPCAT, Encompass, QLIMS, QLIMS2000, QNET)
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Degree and 1-2 years’ relevant experience; or equivalent combination of education, training and experience.
Extensive use of keyboard requiring repetitive motion of fingers.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
Regular sitting for extended periods of time.
EEO Minorities/Females/Protected Veterans/Disabled