Stratus Therapeutics

Clinical Trial Manager (Senior)

Watertown, MA
Full Time
Clinical
Mid Level
Position Title: (Senior) Clinical Trial Manager
Reports to: Director of Clinical Operations
Status: Regular, Full-Time, Exempt
Location: Boston area (Hybrid – In office on T,W)

Company Summary: Stratus Therapeutics is pioneering a new era in regenerative medicine with Stratus Prime™ — an off-the-shelf platform delivering Prime HSCs™ and Prime HPCs™ to restore the blood and immune systems where finding fully matched donors continues to be a challenge. Backed by leading life sciences investors, we are committed to developing universal, on-demand stem cell solutions to give physicians and their patients the power to replace the entirety of blood and immune function. This commitment, along with an exciting team culture, drives our efforts to develop an off the shelf stem cell therapeutic platform.

Position Summary: The Clinical Trial Manager (CTM), in consultation with and support from Clinical Operations leadership, is responsible for all day-to-day operational aspects of a clinical study from setup through final report. The CTM coordinates the activities of other in-house and clinical team members (e.g., Clinical Trial Associates, Data Managers, Supply Chain, etc.), as well as external clinical vendors and/ or consultants. The CTM also assumes the role of the in-house Lead Clinical Research Associate for a study, as needed.



Specific responsibilities include, but are not limited to:
  • Lead and manage all operational aspects of assigned clinical trials (Phase 1–3), including CRO/vendor oversight, site management, study timelines, budgets and deliverables
  • Serve as the primary point of contact for internal stakeholders, CROs, and other external vendors for assigned trial(s)
  • Proactively identify risks, issues, and roadblocks, and implement data-driven solutions before they impact trial progress
  • Apply strong critical thinking to interpret complex clinical and operational issues, escalate as appropriate, and lead cross-functional problem-solving efforts
  • Monitor study progress using key performance indicators (KPIs) and metrics to ensure adherence to protocol, GCP, and regulatory requirements as well as the project budget
  • Be accountable for departmental quarterly metrics
  • Participate in protocol development, site selection, feasibility assessments, ICF review, and other essential documents
  • Collaborate closely with cross-functional partners including Regulatory, Program Management, Biostatistics, Data Management, and QA to ensure seamless execution
  • Lead the development of study tools, training materials, site communications, and trial management plans
  • Develop and manage clinical trial budget and facilitate contract review with Legal and vendor partners
  • Monitor CRO and vendor adherence to scope of work (e.g. confirmation of units consumed, oversight of milestone and deliverable schedule)
  • Participate in vendor, site and CRO audits as appropriate
  • Participate in site monitoring visits as necessary
  • Plan and present at investigator meetings, company, and other meetings as necessary
  • Develop internal tracking and reporting tools for reporting study status to leadership and facilitate internal and external project team meetings
  • Adhere to relevant company policies and SOPs, cGCP/ICH guidelines, QC/QA procedures, as well as relevant clinical regulatory requirements

Qualifications include:
  • 5+ years of clinical trial operations experience in a biotech, pharmaceutical, CRO, clinical research site or related healthcare company
  • Experience working on a multi-phase early phase (Phase 1 & 2) clinical program
  • Cell therapy experience is preferred.
  • Regulatory Authority Inspection experience preferred
  • Robust understanding of the drug development process
  • Highly organized, outcome-oriented, self-motivated performance
  • Ability to analyze complex issues objectively, using relevant KPIs, and applying a data-driven mindset, to develop and recommend trial-related plans, mitigations, and solutions.
  • Ability to thrive in a fast-paced and evolving environment
  • High level of integrity, ethics, and discretion
  • Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills
  • Strong working knowledge of cGCP/ICH guidelines, and US and international clinical regulatory requirements
  • Strong written and oral communication skills
  • Comfortable navigating ambiguity and adapting quickly to shifting priorities
  • Excellent problem-solving and decision-making skills with a “roll-up-your-sleeves” mindset
  • Periodic travel related to project meetings and/or team meetings, may be required
  • Ability and willingness to travel domestically and internationally (10-20%)
  • Must be able to laugh and contribute to a positive work culture.
     
Education:
  • Bachelor’s degree in a scientific discipline is required
  • Advanced degree or certification is a plus


Note:

This job description is written as a guideline to inform a current or prospective Stratus employee of what is or will be generally expected in a given position. The description is not intended to be all-encompassing or limiting in any manner. Duties and responsibilities other than those listed above may be included as needed.
 
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