Senior Clinical Trial Manager (Contract, Remote)

Department: Clinical Operations

Location: South San Francisco, California, United States

Senior Clinical Trial Manager (remote contract)

In this contract role as Senior Clinical Trial Manager (Sr. CTM), you will be responsible for all study management aspects of assigned clinical trials with varying complexity.  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.

This is a six-month contract assignment offering approximately 40 hours per week of work.  Independent contractors not represented through an agency will be paid through our partner, Eastridge Workforce Solutions.  The clinical operations team is based at our corporate headquarters in South San Francisco, CA; however, this contract opportunity is open to a remote engagement.

Qualified Contractors should have experience that includes:  

  • Manage 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
  • Manage clinical monitoring activities (i.e., site visit reports, protocol deviations, Sponsor oversight visits) to ensure Sponsor oversight and compliance with regulatory requirements
  • Lead internal and external development of key study documents including study protocol, study procedure manuals and project tools, monitoring plans and informed consent forms
  • Oversee forecasts to maintain adequate clinical and non-clinical supplies for assigned clinical trials
  • Analyze/report safety issues, patient care issues, and study design and/or study conduct issues
  • Develop/direct clinical monitoring plans, study management plans and direct study monitoring priorities
  • 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
  • Contractors with fluency in Mandarin, or experience working on global trials in Asia, or knowledge of HBV and infections disease will be given priority review

COVID-19 Vaccination

As a condition of this contract assignment, you will be required to show proof that you are fully vaccinated by the first day of your assignment, even if you will be working in a remote capacity.  You are considered fully vaccinated two weeks after your second dose in a 2-dose series, (Pfizer or Moderna vaccines), or two weeks after a single-dose vaccine, (Johnson & Johnson’s/Janssen vaccine).  If you are unable to be vaccinated for a medical or disability-related reason, or a deeply held religious belief, Human Resources will discuss potential exemptions and accommodations with you. 

About Assembly Bio

Assembly Biosciences (NASDAQ: ASMB) is an ambitious clinical stage biopharmaceutical company with cutting-edge therapeutics potentially capable of improving the lives of millions living with chronic hepatitis B virus (HBV) infection around the world.  We are currently focused on 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. 

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 set our sights high—and pursue our goals with determination. Our unique organization stands ready to welcome talented, motivated individuals, who share our ambitions.

As an equal opportunity employer, we are committed to diversity and inclusion and will not tolerate discrimination and harassment of any kind.  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.

Information for Recruitment Agencies

Assembly Bio does not accept from recruiters/agencies any unsolicited resumes, or any candidate information including blinded resumes and will not be responsible for any fees related to resumes or candidate information that is unsolicited.  Please do not contact hiring managers or Assembly Bio employees directly with any information related to a resume or a candidate.  We handle all recruiting through our internal Human Resources team, and we will reach out to you directly should we wish to engage in a search.  Your willingness to comply with this will significantly impact any decision we may make about doing business with you.

 


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