Clinical Trial Manager

Job Summary:

The Clinical Trial Manager is the Regional or Global Protocol Lead in Regional Clinical Trial Operations (RCTO) responsible for the coordination of clinical operations required to initiate, execute and complete clinical trials to drive on-time delivery of clinical trial milestones.

Key Accountabilities:

Oversight & Support of Project Cycle

• Acts as Global or Regional Protocol Lead. Serves as main point of contact for clinical site management
• Monitors metrics to drive on-time delivery of clinical trial milestones
• Assists with creation and review of protocols/informed consent forms (ICFs) and clinical trial documents
•  Leads in identification, evaluation, and selection of clinical trial sites
• Coordinates and manages vendor processes. May contribute to vendor selection
• Leads functional teams within RCTO
• Conducts data review
• Accountable for completeness of Trial Master File (TMF)
• Supports audit and/or inspection activities
• Primary point of contact for CRO activities
• May lead process improvement initiatives and departmental projects

Collaborative Relationships

• May act as mentor for less senior RCTO staff on the study
• Participates as the main point of contact for RCTO on the Clinical Study Team
• Supports Molecule Lead. Closely collaborates with internal study team members, Contract Research Organizations (CRO), vendors or sites
• Facilitates communication between sites and Seagen cross-functional staff

Compliance with Parexel standards

• Complies with required training curriculum
• Completes timesheets accurately as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills:

• Excellent leadership, communication, and organizational skills. Able to multi-task under limited direction and on own initiative
• Ability to proactively handle multiple tasks, manage a diverse range of functional activities and solve problems simultaneously
• Strong communication and inter-personal skills
• Highly responsive and proactive
• A team player
• Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, electronic data capture and eTMF)
• Proficiency in written and spoken English required
• Proficiency in local language as applicable
• Ability and willingness to travel

Knowledge and Experience:

• Minimum of 6 years of relevant clinical trial management experience
• Oncology clinical research experience is preferred
• Global Phase I-III trial Management experience is preferred
• CRO management is preferred
• Experience managing large teams (direct or dotted line reporting) is preferred

Education:

• Bachelor of Arts/Bachelor of Sciences or equivalent or any relevant and qualifying training

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.