Medical Monitor (Board‑Certified Internal Medicine)
PSI CRO · Singapour
Description du poste
About the role
Join PSI’s Medical Monitoring team as a Board‑Certified Internal Medicine physician. You will work with an international group of medical professionals to ensure the safety and scientific integrity of clinical trials for novel medicines.
Key responsibilities
- Advise clients, project teams, sites, DSMBs, regulatory agencies and vendors on medical matters.
- Collaborate on clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts and scientific presentations.
- Review and analyse clinical data to safeguard study participants and ensure data accuracy, completeness and compliance with approved protocols.
- Address safety issues, participate in bid defense meetings and support pharmacovigilance activities.
- Identify program risks, develop mitigation strategies with Clinical Operations, and organise clinical development advisory boards and safety monitoring boards.
- Ensure study team compliance with local regulatory agencies, ICH and GCP guidelines, and sign‑off on clinical documents for medical relevance.
Required profile
- Medical Doctor degree with Board‑certification in Internal Medicine.
- Extensive experience in clinical research, including interactions with health authorities.
- Strong knowledge of clinical concepts, practices and local regulations governing clinical trials.
Required skills
What we offer
- Opportunity to work on cutting‑edge clinical trials with a global pharmaceutical partner network.
- Collaborative environment with a focus on professional development and scientific impact.
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PSI CRO
Singapour
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