Senior/Clinical Trial Manager

Full Time
Posted
1 month ago

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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