Job Summary
We are currently seeking a Lead CRA / Clinical Lead based in Shanghai or Guangzhou to join our clinical development team. This person will be responsible for providing operational expertise and leadership to ensure the effective and efficient delivery of clinical site management in our clinical trials, in cooperation with CRO vendor teams throughout the lifecycle of a study. The Lead CRA will assess clinical trial site performance (especially subject recruitment & operational quality) & adequacy of CRO monitoring activities, co-review monitoring visit reports and metrics, and proactively identify and communicate site management and monitoring issues and risks to the study team. This position offers an excellent opportunity for someone who enjoys working in a fast-paced company where he or she will have the opportunities to take ownership of his or her own work, enhance his or her current abilities and have an exciting and rewarding career in drug research and development while making a positive impact to lives of cancer patients.
Responsibilities
1）Serve as the lead of site-related clinical operations in clinical study projects, and to contribute to the accomplishment of study objectives outlined by the global clinical development plan
2）Oversee and manage CRO clinical operation teams, other third-party vendors and contractors, to ensure delegated outsourced activities are delivered according to contract
3）Contribute to the development and active management of study-specific patient recruitment strategies, keep track of study enrollment and keep in good relationship with sites
4）Collaborate with multiple study functions at CROs and vendors, including data management and EDC, drug supply chain, biostatistics, medical and pharmacovigilance, regulatory, etc.
5）Help with development of study tools, guidelines and training materials
6）Support all aspects of study management, including cost, time, quality, safety, communication, risk, vendors, stakeholders at a global scale
Qualifications
1）Bachelor or Master’s degree in scientific, biological, and life sciences
2）At least 4 years’ experience in the biopharmaceutical industry and clinical trial related activities
3）Understanding the process of drug development, with experience in global clinical operations preferred, with experience in biotech / CRO preferred
4）Knowledge and familiarity with industry standards including ICH guidelines, GCP and regulations
5）Performance driven with ability to work independently, with proven operational and tracking skills
6）Excellent organizational and priority management skills
7）Exceptional interpersonal and communication skills with conflict resolution and consensus building abilities
8）Highly collaborative and works well in a team environment, especially able to work effectively with colleagues from different
cultures, backgrounds and geographies
Language：
English、Mandarin
申請(qǐng)?jiān)撀毼?/a>
