Senior/Clinical Trial Manager
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.
- 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.
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