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Sr. Manager, Clinical Operations

Philadelphia, PA

About the Position

Reporting to the Vice President, Clinical Operations, for assigned studies, the Senior Manager, Clinical Operations provides functional oversight and support to clinical operations team in planning, conduct, and closeout of assigned clinical studies assuring consistency across regions and compliance with GCP/ICH and study objectives.  Directly manages the operational delivery and finances of assigned studies globally.

Responsibilities Include

  • Responsible for all operational aspects of study management including management of project timelines and critical path milestones, country and site selection and activation, site management and monitoring, document management, data management, and management of clinical supplies globally including supply and re-supply planning and projecting and tracking of demand for study investigational compounds.
  • Responsible for identification of, onboarding, and ongoing oversight of multiple vendors supporting the conduct of assigned studies.
  • This role requires direct, hands-on execution of tasks associated with the responsibilities described herein, in addition to management of tasks outsourced to vendors. Utilize project management analytical methods to assess progress and risks for assigned studies.
  • Responsible for compliance of work products to internal and external regulations to avoid unacceptable risk to assigned project.
  • Collaborates with VP, Clinical Operations and Finance for the overall financial management of assigned studies supporting the development of clinical study budgets, procurement of outsourced services, and forecasting and tracking of actual vs. planned expenses. This includes oversight of vendor quality control, contract delivery according to specifications, and overall performance.
  • Keeps management apprised of critical path activities along with risks, issues, or resource requirements pertaining to project plans and timelines and works with the study team to develop appropriate solutions.
  • Contributes to departmental initiatives related to continual process improvement including information and tracking systems, document management, metrics, cost and resource analysis, and the enhancement of clinical operations SOPs.

Required Qualifications

  • Bachelor's degree preferred; RN or Associate Degree in an allied health profession with appropriate experience may be considered.
  • Minimum 6 years clinical research experience, with 4 years of clinical project management experience including management of study resources, budgets, supplies, critical path activities and risk management required.
  • Knowledge of broad clinical trial functional areas and their respective deliverables including document management, regulatory affairs, monitoring, data management, safety, medical affairs, medical writing, and statistical analysis.
  • Working knowledge of GCP/ ICH regulatory guidelines.
  • Experience managing within a matrix management organization preferred.
  • Experience managing Contract Research Organizations and other external vendors (e.g., central laboratory vendor, etc.).
  • Proficient with project management tools and analysis of metrics.
  • Management of global clinical trial preferred.
  • Cell therapy/or oncology experience strongly preferred.
  • Strong attention to detail, good organization and communication skills, and ability to work independently.
  • Must be willing to travel to meetings, study sites, and vendors based on study demand estimated at 20%.

How to Apply

Please email careers@cabalettabio.com directly to submit an application.

Please include your CV along with the title of the position you are applying for.

Benefits

Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.

Equal Opportunity Employer

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.