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), BioTalentis 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. 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. If interested, please do not hesitate to submit your profile for consideration!
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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), BioTalentis 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. 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. If interested, please do not hesitate to submit your profile for consideration!
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