Clinical Data Architect for CTMS & Source Docs

ECN Operating LLC; United States; Remote; USD 65,000 - 90,000; Full time

Job summary

ECN Operating LLC is seeking a Clinical Data Specialist to bridge Contracts, Clinical Operations, sites, and CTMS teams. You will develop and standardize source documentation, ensure data quality, and support system optimization and regulatory readiness across the network.

You will read CTAs to reflect contractual and protocol requirements in study systems, perform accurate data entry, and review CTMS templates before deployment, while collaborating across departments to maintain compliance and

Qualifications

• Education as stated: associates or bachelor in healthcare or life sciences.
• 3-5 years in clinical research, regulatory affairs, or study start-up.
• Experience with CTMS and eRegulatory systems.
• Proficiency with Microsoft platforms.
• Ability to manage multiple studies and deadlines in fast-paced env.

Responsibilities

• CTA interpretation to reflect terms in source documentation and CTMS templates.
• Data entry into CTMS and related systems ensuring data integrity.
• CTMS template review for accuracy and regulatory alignment.
• Design standardized source document templates aligned with protocols.
• Ensure CTMS templates and source documents are synchronized to prevent silos.
• Address audit findings by implementing network-wide standards for source management.
• Serve as primary site contact for source management and data entry.
• Collaborate with CTMS team and Clinical Operations on regulatory updates.

Skills

Strong communication

Cross-functional collaboration

Regulatory compliance

Attention to detail

Data entry

Education

Associate’s or Bachelor’s degree in healthcare, life sciences, or equivalent experience

Tools

CTMS

eRegulatory systems

Microsoft Office

Job description

ECN Operating LLC is seeking a Clinical Data Specialist to bridge Contracts, Clinical Operations, sites, and CTMS teams. You will develop and standardize source documentation, ensure data quality, and support system optimization and regulatory readiness across the network.

You will read CTAs to reflect contractual and protocol requirements in study systems, perform accurate data entry, and review CTMS templates before deployment, while collaborating across departments to maintain compliance and