Senior Clinical Data Manager - Lead Data Quality for Trials

BeiGene; United States; Remoto; USD 109.000 - 144.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

Descrizione del lavoro

BeOne Medicines Ltd. seeks a Senior Clinical Data Manager to lead data management from study start-up through database lock, ensuring the quality of reviewers’ deliverables in oncology trials.

The role collaborates with study leads, performs data cleaning, manages queries, generates reports, and supports eCRF development and UAT. Requires 5+ years in clinical data management, Oncology experience preferred, BS in health, and Medidata Rave proficiency. Travel may be required.

Competenze

• 5+ years of experience in clinical data management in pharma/biotech
• Oncology experience preferred
• Ability to work in cross-functional teams
• Understanding of ICH/regulatory environment for data management
• Strong communication and project management skills

Mansioni

• Supports and works closely with study leads for assigned studies.
• Performs data cleaning/reconciliation as per DM documents.
• Manages queries on assigned studies.
• Generates and delivers reports to study teams.
• Supports external data reconciliation and SAEs.
• Ensures lab data review and reconciliation where applicable.
• Maintains DM documentation (e.g., DMPs, eCRF guidelines).
• Supports eCRF and edit check development for protocol requirements.
• May lead Phase I–II studies under supervision.
• Travels as needed.

Conoscenze

Clinical data management

Data cleaning

Query management

Regulatory knowledge

Analytical thinking

Formazione

Bachelor's degree or equivalent in health-related field

Strumenti

Medidata Rave

Microsoft Office

Descrizione del lavoro

BeOne Medicines Ltd. seeks a Senior Clinical Data Manager to lead data management from study start-up through database lock, ensuring the quality of reviewers’ deliverables in oncology trials.

The role collaborates with study leads, performs data cleaning, manages queries, generates reports, and supports eCRF development and UAT. Requires 5+ years in clinical data management, Oncology experience preferred, BS in health, and Medidata Rave proficiency. Travel may be required.