Global Clinical Data Manager – EDC & SDTM Lead

RiseMe; United States; Hybrid; USD 95,000 - 130,000; Full time

Benefits offered by this job

Bonuses

Equity-based incentive program

Generous vacation

Paid wellness days

Learning and development support

Job summary

Telix Pharmaceuticals is seeking a Clinical Data Manager to ensure data integrity and regulatory compliance across Telix clinical trials. You will oversee EDC development, data transfers, and data cleaning, coordinating with external vendors to meet strict timelines.

Role requires 3+ years in clinical data management with leadership experience; familiarity with CDISC standards (CDASH/SDMT) and GCP is essential. Occasional travel up to 20% may be required.

Qualifications

• Bachelor's degree in Health Information Management, Life Sciences or equivalent; advanced degree preferred.
• 3+ years in clinical trial data management with at least 1 year leading data management independently for global trials.
• Experience creating data management documents (eCRF specs, edit checks, DMP, Data Review Plans, eCRF Completion Guidelines, UAT plans and test scripts).

Responsibilities

• Act as primary data management SME for assigned Telix clinical trials.
• Oversee EDC build including DMP, data review plans, eCRF specs, UAT, and data transfer agreements.
• Lead data entry and cleaning activities for trials.
• Ensure completeness of eTMF documentation.
• Coordinate with external vendors to meet timelines and deliverables.
• Support protocol and SAP development as needed.
• Assist in audits, inspections and study kick-off meetings.
• Ensure compliance with GCP, CDISC standards and related regulations.
• Support internal clinical data management initiatives.

Skills

Data management leadership

Vendor management

Attention to detail

Organizational skills

Regulatory knowledge

Education

Bachelor's degree in Health Information Management, Life Sciences or equivalent

Advanced degree preferred

Tools

EDC systems

eCRF tools

UAT testing

Job description

Telix Pharmaceuticals is seeking a Clinical Data Manager to ensure data integrity and regulatory compliance across Telix clinical trials. You will oversee EDC development, data transfers, and data cleaning, coordinating with external vendors to meet strict timelines.

Role requires 3+ years in clinical data management with leadership experience; familiarity with CDISC standards (CDASH/SDMT) and GCP is essential. Occasional travel up to 20% may be required.