Biospecimen Data Operations Lead

1001 Syneos Health, LLC; United States; On-site; USD 80,000 - 140,000; Full time

Benefits offered by this job

Company car/allowance

Health benefits

401k match

Stock Purchase Plan

PTO & sick time

Job summary

Syneos Health, LLC in the United States seeks a Biospecimen Operations Manager to oversee local LLNR data within clinical trials, coordinating with CDLS and DM teams. You will ensure quality, accuracy, and efficiency in LLNR/LOINC handling across studies.

You will lead training, resolve data issues, and collaborate globally on process improvements, regulatory alignment, and budget considerations, ensuring compliant, timely data delivery.

Qualifications

• BA/BS in biological sciences or related field or RN.
• Strong project management and leadership skills.
• Experience in Clinical Data Management and LLNR data handling.
• Knowledge of laboratory analytes, units, and normal/abnormal ranges.

Responsibilities

• Identify annual updates on local Lab normal Ranges LLNRs based on their effective dates.
• Check LLNR against protocol required analytes and notify CDLS on protocol changes.
• Support Central Repository: lab availability verification, LLNR data entry, export QC.
• Data Management: LLNR/LOINC entry, query resolution, LLNR listings, DVS design, UAT testing of DB with Local Lab component.
• Create, present, and mentor teammates on LLNR/LOINC data.
• Conduct quality reviews for onboarding to prove competency on LLNR tasks.
• Resolve LLNR/unit conversion issues with Biostatistics and Medic as applicable.
• Serve as SME/POC for LLNR procedures across studies and assist in DM budget planning.

Skills

Communication skills

Presentation skills

Interpersonal skills

Project management

Multitasking

Attention to detail

Analytical thinking

Education

BA/BS in biological sciences or related

B. Tech or N. Dip Biomedical Technology

Registered Nurse

Job description

Syneos Health, LLC in the United States seeks a Biospecimen Operations Manager to oversee local LLNR data within clinical trials, coordinating with CDLS and DM teams. You will ensure quality, accuracy, and efficiency in LLNR/LOINC handling across studies.

You will lead training, resolve data issues, and collaborate globally on process improvements, regulatory alignment, and budget considerations, ensuring compliant, timely data delivery.