上海招聘

RESPONSIBILITIES

· Be responsible for CRA team management and operational management system.

· Oversees the performance of the CRAs within their specified team. Implements professional development and performance evaluations;

· Ensures that clinical monitoring activities of their assigned team are performed to the project’s satisfaction, ensuring timely quality deliverables, within budget and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices and study-specific requirements;

· Supports the training and development of clinical monitoring personnel within their remit and ensures team members’ consistent use of study tools and training materials;

· Tracks clinical monitoring metrics such number of site visits performed, utilization, and timeliness to complete deliverables such as site visit report finalization, follow-up letters, timesheets, expense reports and required trainings;

· Performs on-site Accompanied Site Visits with CRAs;

· Identifies quality issues related to clinical monitoring activities through project meetings, site communications, site visit reports and follow-up letters, Accompanied Site Visits, and quality assurance audit findings. Summarizes findings and establishes action plans to bring corrective actions;

· Serves as a point of contact for CRAs and other team members for assigned projects or initiatives;

· Assists with assessing and interviewing potential clinical monitoring candidates;

· May conduct on-site monitoring visits to offer support to project teams;

· May perform site visit report review and track site visit report metrics to ensure compliance;

· May review and provide feedback on related SOPs and TOOLs during updates;

· Serves as a management contact for sites, project teams, and sponsors when issues related to clinical monitoring and trial management activities must be escalated to ensure communication is maintained and resolution is achieved.

Education

· B.Sc. in a field relevant to clinical research

Experience

· Minimum of 10 years of experience in clinical research in the biotechnology, pharmaceutical, or CRO industry

Knowledge and skills

· Excellent oral and written English skills.

· Excellent line management skills

· Strong knowledge of ICH/GCP standards and applicable regulatory requirements;

· Quick learner, good adaptability and versatile;

· Excellent leadership, judgement and problem-solving skills;

· Strong organizational, communication, time management and multi-tasking skills;

和黄中国医药科技有限公司（简称“ 和黄医药 ”或“ Chi-Med ”）（纳斯达克 / 伦交所：HCM）是一家创新型生物医药公司，在过去20年间致力于发现和全球开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。目前，和黄医药共有8个抗癌类候选药物正在全球开发中，并在中国本土市场拥有广泛的商业网络。

和黄医药成立于2002年，为在纽约和伦敦两地上市的和黄中国医药科技有限公司（纳斯达克/伦交所： HCM）旗下专注于新药研发业务的子公司, 研发中心坐落在上海浦东张江高科技园区，海外临床开发及注册中心位于美国新泽西，具有完备的研发平台和GMP生产基地。管理团队成员均有在知名跨国医药和生物医药企业工作的经历，参与了多个全球新药研发；公司目前有500余位来自海内外，拥有丰富新药研发经验的科研人员，8大临床在研药物、 30多项临床试验在全球开展。

和黄医药是一家致力于创新药物研发的生物医药公司，专注于发现和开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。 自主研发的抗肿瘤新药呋喹替尼已于2018年9月获国家药品监督管理局批准上市，并于2019年11月获纳入国家医保药品目录。公司的其他候选药物，如索凡替尼、沃利替尼等，也已进入后期开发，有望在2020及2021年上市。