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Clinical Trial Manager

Department: Clinical Operations
Location: Cambridge, MA

Why Seres Therapeutics

At Seres Therapeutics, we have a singular mission to transform the lives of patients by targeting the underlying cause of their diseases.  We are pioneers and explorers, charting a new course.  You’ll have the opportunity to truly define your area of focus.

If you have a pioneering spirit, join us as we ignite a revolution in the treatment of disease through the microbiome.

What’s Your Mission?

As a Clinical Trial Manager (CTM), you will report in to a Director of Clinical Operations. Your mission is to drive the execution of ongoing clinical studies. As such, you will directly impact Seres’ ultimate goal, of developing novel microbiome therapies to patients in need. 

You will need to independently organize and manage multiple clinical trial activities including facilitating cross-functional team meetings, managing vendors, and addressing protocol related questions. You will also be ensuring that study milestones are met and that the trial is completed in accordance with the protocol.

What You’ll Do

  • Assist in the selection and management of CROs, vendors and consultants that are involved with the clinical trial
  • Oversee vendor(s) to ensure compliance with contract specifications (including budget), SOPs and the study Oversight Plan
  • Establish/maintain study milestones and ensure accurate tracking and reporting of study metrics and timelines
  • Organize and facilitate/document study cross-functional team meetings
  • Serve as point person for trial execution
  • Review study Trial Master File periodically for quality control measures
  • Review and provide input for reports and clinical documents such as informed consent, protocols Investigator’s Brochure, yearly updates to the regulatory authorities and status updates
  • Responsible for communication and escalation of study related risks and issues as required
  • Ensure study staff is appropriately trained on relevant guidelines, regulations and SOPs
  • Assist in the oversight of monitoring activities and site visits
  • May represent Clinical Operations in cross-functional initiatives

 

What You’ll Bring

  • Knowledge – thorough understanding of GCP/regulatory requirements
  • Proactiveness – the ability to identify challenges and risks and implement appropriate actions with some supervision
  • Motivation – highly motivated and self-starter; able to organize and perform complex tasks with minimal supervision
  • Strong communication – able to communicate clearly (in writing and verbally)
  • Collaboration – to coordinate activities of internal cross-functional study team as well as external vendors as applicable
  • Leadership – skills to lead and motivate a team for timely study execution
  • Open-mindedness – listen to ideas from others and seek guidance when applicable; inform manager as situations arise to brainstorm and seek best solutions

You May Also Bring

  • Demonstrated computer skills including functional knowledge of Microsoft packages and ability to develop proficiency in technical systems and programs
  • Experience developing, reviewing, and approving study operational plans including site monitoring and risk mitigation strategies, trial budgets, site feasibility and clinical metrics tracking reports
  • Experience managing CROs, vendors, and/or clinical trial consultants
  • B.S. (or equivalent experience) and 3 - 6 years of relevant work experience
  • M.S. (or equivalent experience) and 2 - 4 years of relevant work experience

Who We Are

Seres Therapeutics is a clinical stage biotherapeutic company focused on discovering and developing Ecobiotic™ therapeutic products, novel drugs to treat important diseases by targeting the underlying biology of the human microbiome.  Founded by Flagship VentureLabs, Seres is pioneering the first therapeutics that catalyze a shift to health by augmenting the biology of the microbiome.  Current candidates span infectious, metabolic, and inflammatory diseases.  For more information, please visit http://serestherapeutics.com/

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