External Data Governance Lead for CDM & Quality

Caraway Therapeutics, Inc.; Województwo mazowieckie; In loco; PLN 90.000 - 140.000; Tempo pieno

Descrizione del lavoro

Merck & Co., Inc. is seeking an External Data Management Specialist to support trial-level external-data activities, author transfer specifications, and coordinate with service providers for accurate data ingestion.

You will perform completeness, reconciliation, and traceability checks, apply standards, and assist with audits, inspections, and continuous improvement initiatives in a regulated environment.

Competenze

• Understanding of the clinical development process and end-to-end trial data flow.
• Knowledge of clinical trial data structures and tools including EDC and data acquisition tools.
• Able to interpret mapping rules, review load logs, and recognize data-integration defect patterns.
• Basic knowledge of CDISC standards (SDTM, CDASH) and controlled vocabularies (e.g., LOINC).
• Communicates effectively with technical and business partners; adapts style to audience.
• Collaborates across functions; facilitates small working sessions and follows through on actions.
• Works independently; proactively identifies risks and proposes options.
• Leadership: develops partnerships, executes with quality, and takes accountability.

Mansioni

• Gather external data requirements from protocols, providers, and study stakeholders.
• Develop external data specifications with stakeholder approvals.
• Execute test and production file reviews against approved specs.
• Monitor external data file loads, review error logs, and resolve issues.
• Support data reconciliation and validation to ensure CDM readiness for review and lock.
• Participate in governance forums and track KPIs and timelines.
• Identify and communicate risks to study leads and cross-functional teams.
• Support QA activities including audits and CAPA resolution as required.
• Provide status updates in meetings with internal and external teams.
• Partner with GDMS and cross-functional teams to align on priorities.

Conoscenze

Clinical Data

Clinical Databases

Clinical Data Management

English Language

Services Management

Vendor Management

Descrizione del lavoro

Merck & Co., Inc. is seeking an External Data Management Specialist to support trial-level external-data activities, author transfer specifications, and coordinate with service providers for accurate data ingestion.

You will perform completeness, reconciliation, and traceability checks, apply standards, and assist with audits, inspections, and continuous improvement initiatives in a regulated environment.