Remote Biospecimen Operations Lead

Syneos Health, Inc.; North Carolina; Hybrid; USD 80,000 - 140,000; Full time

Job summary

Syneos Health is seeking a Clinical Data Manager to support LLNR data management across clinical studies. You will review local lab data, ensure LLNR accuracy, and coordinate with the CDLS and data management teams to maintain data quality.

You will participate in training, mentoring, and process improvements, while ensuring regulatory compliance with ICH/GCP standards and collaborating with biostatistics and CRO partners as needed.

Qualifications

• Bachelor’s degree in biological sciences or related field; RN with relevant experience acceptable.
• Extensive experience with local laboratory data collection and LLNR data in clinical trials.
• Knowledge of ICH/GCP regulatory requirements for clinical studies.

Responsibilities

• Quality check data received via SNOW to ensure accuracy.
• Identify annual updates on LLNRs based on their effective dates.
• Entry and QC of LLNR/LOINC data in the clinical database and related tasks.

Skills

Project management

Communication skills

Attention to detail

ICH/GCP knowledge

Clinical data management

Education

BA/BS in biological sciences or related field

Registered Nurse

B.Tech or N.Dip Biomedical Technology

Tools

LOINC

eCRF

Clinical Data Management systems

Job description

Syneos Health is seeking a Clinical Data Manager to support LLNR data management across clinical studies. You will review local lab data, ensure LLNR accuracy, and coordinate with the CDLS and data management teams to maintain data quality.

You will participate in training, mentoring, and process improvements, while ensuring regulatory compliance with ICH/GCP standards and collaborating with biostatistics and CRO partners as needed.