锦鲤求职岗位描述
【Key Responsibilities】
<p>Trial Design and Protocol Development</p> <p>Collaborate with cross-functional teams to develop robust clinical trial protocols and study designs.</p> <p>Contribute to the development of clinical strategies, including study endpoints, randomization methods, sample size calculations, and statistical analysis plans.</p> <p>Prepare and review clinical study protocols, Investigator Brochures (IBs), Case Report Forms (CRFs), and informed consent forms (ICFs), ensuring alignment with ICH-GCP guidelines and regulatory requirements.</p> <p>Medical Monitoring</p> <p>Oversee study conduct, including site initiation, subject recruitment, and data collection to ensure adherence to protocols and ethical guidelines.</p> <p>Perform regular medical monitoring activities, including review of adverse events (AEs), serious adverse events (SAEs), and laboratory data to assess safety profiles.</p> <p>Collaborate with Principal Investigators (PIs) and study sites to resolve medical queries, manage protocol deviations, and escalate critical issues to leadership.</p> <p>Data Analysis and Report Preparation</p> <p>Collaborate with biostatisticians to review statistical analysis plans and interpret clinical data.</p> <p>Prepare comprehensive clinical study reports (CSRs), interim analyses, and regulatory submissions (e.g., IND/NDA documents).</p> <p>Contribute to the development of scientific presentations, manuscripts, and abstracts for publication or conference presentations.</p> <p>Key Opinion Leader (KOL) Engagement</p> <p>Establish and maintain relationships with academic experts and thought leaders in the therapeutic area.</p> <p>Facilitate scientific discussions, advisory boards, and expert consultations to gather insights and support study strategies.</p> <p>Provide medical education and training to internal/external stakeholders (e.g., CROs, study teams) on study protocols and disease-specific knowledge.</p> <p>Regulatory and Compliance</p> <p>Ensure all study activities comply with global regulatory guidelines (e.g., ICH-GCP, FDA/NMPA requirements).</p> <p>Participate in regulatory meetings and respond to agency queries during IND/NDA submissions.</p> <p>Maintain up-to-date knowledge of evolving regulatory landscapes and therapeutic guidelines.</p>
【Qualifications】
<p>Medical Doctorate (MD) or PhD with a strong background in clinical research.</p> <p>Minimum 3+ years of experience as a CRP in the biopharmaceutical industry.</p> <p>Proven track record in managing clinical trials from design to execution, with experience in global multi-regional studies preferred.</p> <p>Deep understanding of ICH-GCP, clinical trial methodologies, and regulatory submission processes.</p> <p>Strong analytical skills in interpreting clinical data and statistical outcomes.</p> <p>Excellent communication skills (verbal and written) to engage with diverse stakeholders (PIs, regulatory bodies, internal teams).</p> <p>Fluent in English (both verbal and written) to support global communication and document drafting.</p> <p>Ability to work in a dynamic, fast-paced environment and manage multiple projects simultaneously.</p>