Job Title: Oncology Medical Monitor (Remote, US-Based)

Location: Remote (United States)

Employment Type: Full-Time

About the Role:
On behalf of a leading APAC-based Contract Research Organization (CRO), BioTalent is seeking an experienced Oncology Medical Monitor for a remote, US-based position. This role offers a unique opportunity to contribute to ground-breaking oncology trials conducted across APAC and global regions. If you are a medical professional with extensive experience in oncology and a passion for advancing clinical research, we’d love to hear from you.

Key Responsibilities:

• Act as the medical expert for ongoing oncology clinical trials, providing medical oversight and ensuring compliance with protocols, ethical standards, and regulatory requirements.
• Serve as the primary medical liaison for investigators, site staff, and internal clinical teams, addressing medical queries and offering expert guidance.
• Monitor and evaluate safety data, including adverse events (AEs), serious adverse events (SAEs), and protocol deviations, ensuring patient safety and data integrity.
• Contribute to the development and review of essential trial documents, such as protocols, investigator brochures, informed consent forms, and study reports.
• Collaborate with cross-functional teams, including clinical operations, pharmacovigilance, and regulatory affairs, to support trial success.
• Participate in investigator meetings, site initiation visits, and other study-related activities.
• Analyze clinical trial data for safety trends and efficacy signals to guide decision-making.
• Support Data Safety Monitoring Board (DSMB) and Ethics Committee activities as needed.
• Ensure compliance with global and APAC-specific regulatory standards, including ICH-GCP, FDA, and EMA guidelines.

Candidate Profile:
We are looking for candidates who are not only technically qualified but also possess strong leadership and communication skills, with the ability to work collaboratively in a global and remote environment.

Qualifications:

• Education: MD or equivalent medical degree, with board certification or specialization in oncology preferred.
• Experience: At least 5 years of clinical or industry experience in oncology, including 2+ years in medical monitoring or drug development roles.
• Monitors who have practiced medicine in the US 
• Strong understanding of oncology therapeutic areas, including solid tumors, hematologic malignancies, or immuno-oncology.
• Familiarity with global clinical trial operations, particularly in the APAC region, is a significant advantage.
• In-depth knowledge of regulatory requirements (FDA, EMA, ICH-GCP).
• Exceptional problem-solving, decision-making, and organizational skills.

Preferred Skills:

• Experience with immuno-oncology or biomarker-driven studies.
• Previous involvement with APAC-based CROs or sponsors.
• Proficiency in electronic data capture (EDC) systems and safety reporting tools.