Clinical Trial Manager

DESCRIPTION:

We are seeking for a Clinical Trial Manager who will be responsible for cross functional collaboration with functional leads to develop and implement clinical study processes and procedures to ensure the timely execution of quality clinical trials at multiple phases. 

ESSENTIAL FUNCTIONS 

• Develops and coordinate multiple clinical trial and operational activities and manages their execution to ensure completion according to the project timeline and budget.

• Coordinates and leads cross-functional project team meetings that include representatives from multiple internal departments (e.g., Medical Science, Regulatory Affairs, Data Management).

• Reviews/finalizes study protocols, informed consent forms, amendments, case report forms (CRFs), and clinical study reports (CSRs).

• Coordinates the qualification and selection of clinical 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.

• 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.

• 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.

• Develop and maintain tools for management of study deliverables (i.e., timelines, study plans, adherence to monitoring plan and TMF plan, etc.).

• Identifies 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.

REQUIRED QUALIFICATIONS:

· Bachelors degree in (para-) medical, pharmaceutical, sciences, life sciences or biosciences AND minimum 5 years in-house clinical experience in positions of increasing technical and operational responsibility (minimum 3 of those years must include managing all aspect of clinical trials independently) REQUIRED

• Current, working knowledge of Code of Federal Regulations Title 21 Part 314.80, Part 314.81, Part 314.98 and related FDA guidance REQUIRED

• Ability and experience in     presenting logical solutions to complex problems proactively before they have impact on the study REQUIRED

• Thorough working knowledge and understanding of ICH-GCP, and regulatory guidelines and their implementation in clinical trials REQUIRED

· Current, hands-on experience supporting all aspects of study progress and day-to-day activities from start-up to close-out activities assuring compliance and adherence to intended timelines to achieve study goals REQUIRED

· CNS trial experience PLUS

· Small-mid sized pharma or start-up experience PLUS