Senior Clinical Trial Manager

Location
South San Francisco, CA, United States
Posted
Aug 14, 2019
Ref
4387709002
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
As a Senior Clinical Trial Manager (Sr. CTM) in Clinical Operations, 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.

Specific responsibilities include, but are not limited to:
  • 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

Preferred Experience:
  • Minimum 8 years of clinical research experience in the pharmaceutical/biotechnology industry including study management of clinical trials Phase I-III
  • Minimum 2 years managing global trials as a Clinical Trial Manager
  • Minimum 3 years of clinical trial monitoring and/or study coordinator 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:

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'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 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 great people who are driven to transform the lives of patients.

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 with potential total development and commercial milestones of up to $2.8 billion. 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.

Assembly 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 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.

AAP/EEO Statement:

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.