Clinical Trial Manager / Sr. Manager
Location: South San Francisco, California, United States
You will be responsible for all study management aspects of assigned clinical trials with varying complexity (i.e. Phase I study to a global pivotal study) within the clinical development program. You will lead and manage the tactical execution of one or more clinical trials from study start-up through the final study report and ensure the successful delivery of the assigned clinical trials in the context of the broader development program. You will ensure quality oversight of vendors and you will manage people. You will contribute to the development of Standard Operating Procedures (SOPs), work processes, best practices and business solutions for the Clinical Operations group. This position is based at our corporate headquarters in South San Francisco, CA and is not open to remote employment. Relocation assistance is not available for this position.
Specific responsibilities include:
- Manage all operational aspects for the implementation of clinical trial activities from study start-up through database lock, ensuring compliance with country regulations and ICH GCP guidelines
- Assist with selection of investigative sites, train investigators and investigative site staff, and prepare materials for and present at Investigator Meetings
- Analyze/report safety issues, patient care issues, and study design and/or study conduct issues
- Evaluate, manage and facilitate the timely flow of clinical data to support program objectives
- Oversee the forecasts to maintain adequate clinical and non-clinical supplies for assigned clinical trials
- Maintain frequent contact with and works effectively with study stakeholders including investigators, vendors, and internal staff
- Develop and maintain therapeutic area knowledge to support role and responsibilities
- Manage clinical monitoring activities (i.e., site visit reports, protocol deviations, Sponsor oversight visits) to ensure Sponsor oversight and compliance with regulatory requirements
- Assist with review and critique of CRF design for accuracy and completeness; assist with data listing reviews and discrepancy resolution as needed
- Input to and support compilation of sections of protocols and Clinical Study Reports
- Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight
- Lead internal and external development of key study documents including, but not limited to study protocol, study procedure manuals and project tools, monitoring plans and informed consent forms
- Develop/direct clinical monitoring plans, study management plans and direct study monitoring priorities
- Assist with development and maintenance of study progress trackers
- Assist with CRO and external vendor partner selection and management. Includes review of invoices for accuracy compared to vendor contract; may aid in the development of technical specifications for vendors (e.g. scope of work)
- Perform effective ongoing performance and financial management of CRO(s) and vendors
- Manage and coordinate activities of CROs and other vendors
- Ensure audit/inspection readiness including the TMF throughout the conduct of the study
- Ensure CAPAs are completed for issues identified at vendors or identified at sites in coordination with Quality Assurance
- Assist in preparing study budgets and timelines based on program goals within Clinical Development
- Assist with maintenance of study timelines including identifying and communicating trial issues that will impact budget, resources and/or timeline
- Partners with legal and financial functions to negotiate study contracts and budgets
- Develop and maintain study timeline in Microsoft Project
- Contribute to Clinical Operations SOP, Work Instructions, tools and templates, and Best Practices development by providing local clinical operations expertise
- Lead initiatives within Clinical Operations/Clinical Development as part of process improvement efforts
- Identify training needs and develop training plans for direct reports, including on-going training
- Responsible for retention, coaching, career development and performance appraisals of direct reports
- Approximately 10% domestic and international travel may be required for this position
- Not sure if you are qualified for this position? We know that skills and experience can show up in different ways and we welcome resumes from a broad range of applicants. You are encouraged to apply even if you do not meet each of the listed preferred qualifications.
- 8+ years of clinical experience in the pharmaceutical/biotechnology industry including study management of clinical trials Phase I-III. Candidates at the Senior Clinical Trial Manager level are expected to have additional years of experience. Hands-on experience with viral hepatitis, and/or clinical operations in Asia will be considered in lieu of years of actual experience.
- Experience developing study execution strategies, risk mitigation, and successful site/country selection
- Thorough knowledge ICH/GCP guidelines
- Demonstrated proficiency in the implementation, monitoring and management of clinical trials and broad cross-functional knowledge and understanding of clinical trial methodology
- Ability to interpret study level data & translate and identify risks
- Global study management experience in China, India or other countries with high prevalence of HBV and experience in study management of virology trials
- Fluency in Mandarin in both written and oral communication skills is desirable but not required
- Line management experience including performance review and career development for direct reports
- Solid vendor management skills
- Fluency in English in both written and oral communication skills
- Willing to embrace change and work in a changing environment
- Able to work collaboratively across cultures and geographies
- Strong communication skills to ensure that clinical study plans are transparent and risks, issues and results are clear to all SMT stakeholders
- Proficiency in Microsoft Word, Project, PowerPoint, Excel, SharePoint
About Assembly Bio
Assembly Biosciences (NASDAQ: ASMB) is a clinical stage biopharmaceutical company with cutting-edge therapeutics potentially capable of improving millions of lives around the world. 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 great people to our dynamic team who are driven to transform the lives of patients. We are currently focused on the development of two intelligently designed, scientifically novel clinical platforms:
An HBV program intent on creating a new class of oral therapeutics to finally cure hepatitis B. Our program is built on ingenuity, vision and experience and has the potential to improve cure rates for individuals with chronic hepatitis B (HBV) in our lifetime. Our strong scientific expertise in discovering small molecules targeting the HBV core protein has made us a leader in the field.
A Microbiome program of potentially life-changing oral live biotherapeutics to transform the treatment of an entire range of diseases linked to the microbiome. We believe our Microbiome platform represents a best in class approach, translating naturally evolved, bacteria-host pharmacological interactions into rationally selected, live oral biotherapeutics.
Assembly Bio has a strong balance sheet and is well-positioned to advance our innovative research and potential medicines in HBV-cure and the Microbiome. Headquartered in South San Francisco, CA, Assembly Bio also operates a microbiome manufacturing facility in Groton, CT, and has offices in China.
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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