Job Posting Details


Summary

POSITION: Senior/Clinical Trial Manager 

LOCATION: New York, NY

STATUS: Regular, Full-Time

REPORTS TO: Executive Director/Head of Clinical Operations & Project Management

SUMMARY:  The Senior Clinical Trial Manager will be responsible for working with all departmental functions to develop and implement study processes and procedures to ensure the timely execution of quality clinical trial.  The Senior/Clinical Trial Manager will act as a key contact for external stakeholders like CROs and vendors and internal stakeholders like SVP of Clinical Development to address study issues and support the successful execution of clinical trials.

Essential Duties and Responsibilities

  • Develops and coordinates clinical trial and operational activities and manages their execution to ensure completion according to project timelines and budget.
  • Coordinates and leads cross-functional project team meetings that include representatives from multiple internal departments (eg, Medical Science, Regulatory Affairs, Data Management).
  • Review/finalize study protocols, amendments, case report forms (CRFs), and clinical study reports (CSRs). Develops informed consent documents.
  • Coordinates the qualification and selection of investigative sites, plans for, and presents at Investigator Meetings, develops other site training materials.
  • Develops clinical trial timelines, enrollment projections, documents, and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, and risk mitigation plans.
  • Coordinate the vendor selection process, including input and review of the draft RFP, review of returned RFPs, bid defense meetings, audits, and final vendor selection.
  • Manages vendor and CRO activities and tracks internal and external (CRO/vendor) project deliverables to ensure they remain within the timeline and budget.
  • Establishes and maintains regular contact with investigators, vendors and study site staff to ensure GCP/ICH/protocol compliance, and compliance with company SOPs.
  • Performs sponsor oversight of monitoring visits, including site qualification, study site initiation, routine monitoring and study site closure visits including review of monitoring reports and follow-up letters.
  • Responsible for ensuring the development and updating of cost estimates at the study and project level.
  • Oversee and manage CRA team and/or Clinical Trial Assistants, if applicable.
  • Develops the agenda and manages the planning and execution of Investigator Meetings: meeting vendor contracting and management, coordinate development of meeting agenda, content development and delivery of operational (non-Clinical Science) presentations and training materials, manage meeting execution and documentation; ensure input from key stakeholders.
  • Responsible for the development and presentation of slides and training materials for various audiences.
  • Develop subject recruitment/retention strategy and related initiatives.
  • Collaborate and communicate with other functional areas to identify and evaluate fundamental issues on study related projects.
  • Oversee maintenance and quality review of study TMF.
  • Develop and maintain tools for management of study deliverables (i.e., timelines, study plans, adherence to monitoring plan and TMF plan, etc.).
  • Identify potential risks and develop escalation/action plans to avoid or mitigate issues and make the appropriate decisions balancing risks with study quality, deliverables, and costs.
  • Establish efficient / effective working relationships with other functional leaders and coordinators across geographies.
  • Develops and implements risk management strategies and contingency plans for clinical deliverables.
  • Ensures consistency and accuracy in site payment process if applicable.

Requirements

  • For Clinical Trial Manager 5-7 years in-house clinical experience, must include 2+ years managing all aspect of clinical trials independently. (Biotech/Oncology-Hematology Experience is highly preferred). 
  • For Senior Clinical Trial Manager at least 6-10 years in-house clinical experience, must include 4+ years of managing all aspects of clinical trials independently.  (Biotech/Oncology-Hematology Experience is highly preferred). 
  • Able to present logical solutions to complex problems proactively before they have impact on the study.
  • Thorough understanding of ICH-GCP guidelines and their implementation in clinical trials.
  • University degree (equal to 4 years of college) in (para-) medical, pharmaceutical, sciences, life sciences or biosciences.  Equally recognized degree and/or relevant experience may also be considered.
  • Strong organizational and communication skills are a must for this position.
  • The ability to handle multiple priorities within matrix environment is required.
  • Must possess the ability to work independently and be flexible.
  • Fluent in English (written and spoken).  Any other language is an asset.
  • Good computer skills: Word, Excel, PowerPoint, Outlook.
  • May require occasional travel.

TO APPLY:

Send your resume to careers@sellaslife.com



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