Clinical Trial Manager (Senior)

Job Description

Job Description

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 :

Education :

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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