Biospecimen & Lab Data Operations Lead

Syneos Health

United States

On-site

USD 110,000 - 170,000

Full time

7 days ago

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Job summary

Syneos Health is seeking a Biospecimen Operations Manager to lead LLNR data management and LOINC alignment across studies. The role emphasizes QA reviews, data integrity, and mentoring a team responsible for local lab data handling in clinical trials.

The position requires strong knowledge of LLNR/LOINC concepts, experience in clinical data management, and collaboration with statistics, DM, and project teams. Location is in the United States with complex, cross-study workflows.

Qualifications

BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse.
B. Tech or N. Dip Biomedical Technology preferred where applicable in lieu of degree, equivalent relevant work experience.
Clinical Data Management experience with experience particularly of handling LLNR data.
Extensive experience with local laboratory data collection methods and management of LLNR data in clinical trials.
Expert knowledge of laboratory analytes, their unit of measurement and associated normal and abnormal ranges for overall safety management of patients in clinical trials.
Strong knowledge of medical terminology.

Responsibilities

Quality check data received via Service Now (SNOW) to ensure accuracy of information.
Identify annual updates on local Lab normal Ranges LLNRs based on their effective dates.
Check LLNR against protocol required analytes and notify the CDLS team when there are changes to the project.
Assess availability of local labs as required by a project; Verification of LLNR data entered; Generating protocol specific LLNR export and QC of export prior to entry in clinical database.
Entry and filing of LLNRs and LOINC; Review/resolve issues in the clinical database via query management; QC LLNRs entered; Review LLNR/LOINC listings; create additional listings within the Data Validation Specifications (DVS); Design eCRF and testing (UAT) of database with Local Lab component.
Create, present, and oversee training/mentoring of new team members, current team (or other functional areas as required) on local lab data, LLNRs/LOINC.
Conduct/document quality reviews on members onboarding to prove competency on all Clinical LLNR tasks.
Resolution of LLNR/unit conversion issues with Biostatistics and Medic as applicable.
May act as Process owner for the LLNR procedures/templates, serve as clinical laboratory data Subject Matter Expert (SME) and POC for delivery of LLNR related tasks across a portfolio of studies.
May support the Proposal Development team in creating the DM Budget specific CDLS activities.
Required to attend and/or participate/support in Trusted process meetings, internal/external inspections/audits and resolving Quality Issues (QIs) focusing on the management of the LNR and LOINC data.