The Position

The Clinical Operations Study Manager independently manages multiple global clinical trials of moderate complexity. The COSM is expected to manage all sites and vendors (e.g., Contract Research Organizations), with supervision from the Sr. Director, Clinical Operations. Simultaneously manages all aspects of multiple global clinical studies (Phase 1 through 4). The COSM provides project oversight and guidance to junior staff members.

Responsibilities

• Manages study operational plans and CRO activities to ensure coordinated execution and quality of study deliverables
• Contributes to relevant study documentation including clinical protocols, clinical study reports as well as operational plans
• Serves as the main point of contact and coordination on assigned trials for internal and external stakeholders
• Assists in the process of identifying potential vendors, reviewing proposals contributing to the selection process
• Accurately tracks and reports study metrics to study team
• Develops and reviews study related budgets and contracts
• Responsible for approving invoices and overseeing study budgets
• Proactively identifies project risks and resolves with some supervision
• Manages adherence to ICH/GCP/local regulations internally and across sites and vendors
• Establishes and maintains a working environment which fosters open communication, collaboration, integration, and teamwork
• Provides guidance, mentorship and oversight to other Clinical Operations Managers and more junior Clinical Operations staff members
• Participate in clinical operations initiatives and meetings as assigned and other duties as required
• Assists in the preparation of training materials and presentations related to the planning and conduct of the trial
• Oversees the submission of trial-related and essential documents to the Trial Master Files
• Represents Clinical Operations in cross-functional initiatives, as assigned by management, and may act on behalf of team when designated

Requirements:

• 4-year college degree in relevant discipline such as nursing, life science, or related field strongly preferred
• At least 5 years’ experience in Clinical Operations or similar function
• At least 2 years’ experience as a Clinical Operations Manager/Clinical Study Manager, or similar position
• At least 3 years Clinical Monitoring experience
• Thorough understanding of FDA, ICH and GCP guidelines
• Broad understanding of clinical operations related to clinical development functions
• Proficiency with computer programs including Microsoft Office Suite
• Excellent intrapersonal, verbal and written communication skills
• Ability to effectively interface with medical personnel at clinical site(s)
• Strong organizational skills and attention to detail
• Team-oriented with demonstrated cross-functional team leadership and participation skills
• Proficiency clinical project management skills
• Complex problem-solving skills
• Solid vendor management skills (e.g., CRO, Laboratory, Clinical supplies/logistics)
• Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner
• Must be able to work with distributed team members and outside vendors such as clinical research organizations
• Ability to lead multi-disciplinary, cross-functional teams both internally and externally
• Ability to write and edit technical documents, such as protocols, protocol amendments, informed consent documents, and other trial-related documents