Biospecimen Operations Leader (Remote)

Syneos Health, Inc.; Morrisville (NC); On-site; USD 80,000 - 140,000; Full time

Benefits offered by this job

Health benefits

401k matching

Employee Stock Purchase Plan

Paid time off

Job summary

Syneos Health is seeking a robust Clinical Data Manager to manage LLNR data within clinical trials. You will review LLNR data, ensure ALCOA++ data quality, and support data validation on LLNR/LOINC listings.

Ideal candidates have extensive clinical data management experience, CRO exposure, and strong project leadership skills, including training and mentoring of staff in LLNR procedures.

Qualifications

• Bachelor's degree in biological sciences or RN; B.Tech or N.Dip Biomedical Technology preferred where applicable in lieu of degree, equivalent relevant work experience.
• Clinical Data Management experience with LLNR data in clinical trials is required.
• Extensive experience with local laboratory data collection methods and management of LLNR data.
• Knowledge of LLNR/LOINC listings and data quality principles (ALCOA++).

Responsibilities

• Quality check data via SNOW to ensure data accuracy.
• Identify annual updates on local Lab normal Ranges LLNRs by effective dates.
• Check LLNR against protocol required analytes and notify CDLS for changes.
• Assist in Central Repository tasks: assess local labs, verify LLNR data, export LLNR data and QC before entry in clinical database.
• Support Data Management activities: entry and filing LLNR/LOINC, query management, EFT listing reviews, and eCRF/database testing.
• Create, present, and oversee training on LLNR data for new and existing staff.
• Resolve LLNR/unit conversion issues with Biostatistics and Medic as applicable.

Skills

Clinical Data Management

LLNR data

LOINC

ICH/GCP

Project management

Team leadership

CRO experience

Communication skills

Education

BA/BS in biological sciences or RN

B. Tech or N. Dip Biomedical Technology

Tools

eCRF

eDC Database

DVS

Job description

Syneos Health is seeking a robust Clinical Data Manager to manage LLNR data within clinical trials. You will review LLNR data, ensure ALCOA++ data quality, and support data validation on LLNR/LOINC listings.

Ideal candidates have extensive clinical data management experience, CRO exposure, and strong project leadership skills, including training and mentoring of staff in LLNR procedures.