LabConnect
LabConnect

LabConnect atbalsta klīniskos pētījumus un zāļu izstrādi kā globāls centrālo laboratoriju risinājumu partneris. Uzņēmums apvieno centrālos un specializētos bioanalītiskos testus ar radiofarmaceitiskajiem pakalpojumiem, decentralizētu un dzīvesvietai tuvu paraugu ņemšanu, pielāgotiem paraugu ņemšanas komplektiem, pavadošo diagnostiku, analīžu validāciju un laboratorijas datu pārvaldību.

Uzņēmuma komandas palīdz pasūtītājiem un līgumisko pētījumu organizācijām koordinēt sarežģītas pētniecības programmas tādās jomās kā onkoloģija, vakcīnas, šūnu un gēnu terapija. LabConnect nodrošina arī datu harmonizāciju, regulatīvo un zinātnisko projektu vadību, kā arī komerciālu un pēcreģistrācijas atbalstu, īpašu uzmanību pievēršot laboratorijas procesu pārvēršanai uzticamā īstenošanā visā klīniskās pētniecības dzīves ciklā.

Associate Data Manager, Clinical Laboratory Data

Reconcile and validate laboratory data streams at LabConnect, supporting compliant clinical trial transfers. Review data specifications, resolve client queries, and coordinate corrections with internal teams.

Apraksts

  • Reconcile and validate regulated laboratory data streams for clients
  • Correct missing, inconsistent, or inaccurate data
  • Review laboratory files against transfer specifications
  • Prepare test laboratory data for transfer files
  • Develop simple study transfer specifications and notify clients of changes
  • Help improve real-time validity checks in LabConnect’s central laboratory information management system
  • Maintain transfer specifications under the study Data Manager’s direction
  • Design systems that support project needs
  • Send scheduled or requested data transfers to clients and designated recipients
  • Check transmissions against required file structure, format, layout, and specifications
  • Keep analyte reference ranges, decimal precision, units, and correlation factors consistent
  • Create, install, and verify laboratory unit conversion tables
  • Answer client questions about clinical data streams and record outcomes in client databases
  • Work with internal teams and Investigator Support Services to resolve queries and correct errors
  • Keep study schedules aligned with contracts and client communications
  • Complete routine work under the group manager’s direction

Prasības

  • An associate degree or university program certificate in a biological science is preferred
  • Four to six years of clinical trial industry experience is strongly preferred
  • A comparable combination of education and experience may be considered
  • Laboratory experience is preferred
  • Experience with clinical trial protocol development and FDA 21 CFR Part 11/GCP is strongly preferred
  • ASCP Medical Technologist or Medical Laboratory Technician certification is preferred
  • Strong attention to detail
  • Ability to follow established timelines, processes, and procedures
  • Strong planning and problem-solving abilities
  • Ability to work independently and collaboratively
  • Organization, time management, communication, multitasking, interpersonal, and listening skills
  • Ability to adapt to changing environments and requirements
  • Verbal comprehension and ability to convey client needs to team members
  • Ability to make timely, considered decisions
  • Customer service and client relationship management skills
  • Ability to sit at a desk and work on a computer for extended periods
  • Ability to communicate effectively by phone, video, and email
  • Ability to use hands and fingers to operate a computer and other office equipment

Priekšrocības

  • Equal opportunity employer committed to diversity and an inclusive workplace
  • Reasonable accommodations may be made for individuals with disabilities to perform essential job functions
  • Minimal travel required

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