Clinical Program Manager (Beijing)
Department: Clinical Operations
Location: Beijing, China
The Clinical Program Manager (CPM) has accountability and responsibility for the oversight for all assigned studies in China in accordance with the overall study and program-level plans. The CPM provides leadership, regional/local strategic planning and operational delivery of assigned clinical studies across all phases of study management (i.e., preparation, study start-up, conduct, close-out and reporting), in accordance with Assembly Biosciences quality standards, all applicable regulations, timelines and budget commitments. The CPM works closely with, and under the guidance of, the Clinical Operations team at Assembly Biosciences in South San Francisco, California, USA, to ensure seamless integration of China into global clinical studies and/or execution of local clinical studies supporting the broader clinical development programs.
- Represents Clinical Operations at a country-level at the respective Study Management Team (SMT) and provides the SMT with local country guidance and expertise.
- Highlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required and in coordination with SMT Study Leader.
- Coaches and provides support to responsible study team members at Assembly Biosciences, China
- Provides country-level study oversight, leadership and support to Contract Research Organization (CRO) and vendors to ensure overall delivery at the country and site level, and interfaces with CRO country leadership team regarding feedback on CRO staff performance as required.
- Oversees study feasibility, site monitoring performance, and ensures eTMF completeness and oversight of all relevant compliance activities for allocated studies in China.
- Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and completion of Corrective and Preventative Actions (CAPA) for allocated studies in China.
- Provides oversight of the country-level and country site-level TMF and ensures the TMF is inspection ready
- Develops and maintains optimal site relationships with investigator sites and vendors in China for current and future Assembly studies.
- Reviews clinical operational documents including ICF, protocol, study plans, timelines.
- Performs data cleaning activities and reviews study data remotely in EDC and identifies trends and escalates to the SMT as needed.
- Contributes to Clinical Operations SOP, Work Instructions, tools and templates, and Best Practices development by providing local clinical operations expertise.
- Contributes to initiatives within Clinical Operations/Clinical Development as part of process improvement efforts.
- University degree or equivalent; preferably in a medical science-related field and extensive experience and expertise in clinical research/development or related industry.
- Fluent in English (speaking and writing)
- Minimum 5-8 years of clinical research experience (and/or equivalent) in the pharmaceutical/biotechnology/CRO industry (preferably global companies)
- Experience managing industry sponsored clinical trials
- Broad understanding of the drug development process
- Proficiency in MicroSoft Word, Project, PowerPoint, Excel
- Experience using eTMF, EDC, IWRS platforms
- International and domestic travel is required
- Experience in managing, developing and training clinical research professionals is preferred
About Assembly Bio
Assembly Biosciences (NASDAQ: ASMB) is a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome. The HBV program is focused on advancing a new class of potent, oral core inhibitors that have the potential to increase cure rates for chronically infected patients. The microbiome program is developing novel oral live microbial biotherapeutic candidates with Assembly Bio’s fully integrated platform, including a robust process for strain identification and selection, GMP banking and production, and targeted delivery to the lower gastrointestinal tract with the GEMICEL® technology.
We believe our Microbiome platform represents a best in class approach to developing biopharmaceutical agents from live biotherapeutic products. ABI-M201, our lead program in mildly to moderately active ulcerative colitis (UC), is currently in a phase 1b clinical trial. This program is part of a broader collaboration we established with Allergan in 2017 for gastrointestinal programs such as UC, Crohn’s disease and Irritable Bowel Syndromes. Our internal pipeline comprises first in class or best in class live microbial biotherapeutic approaches in areas such as oncology, immune mediated and metabolic disorders, and other areas of high medical need.
We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add to our dynamic team of great people who are driven to transform the lives of patients.
Assembly Bio is headquartered in Carmel, Indiana, while the R&D headquarters is in South San Francisco. The Company also has a microbiome manufacturing facility in Groton, CT, and offices in China. Assembly Bio has a strong balance sheet having raised approximately $166 million in July 2018. We are positioned well to build the next phase of the Company toward global development and commercialization of our innovative medicines in HBV-cure and the Microbiome.
Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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