The incumbent is responsible for conducting tasks related to the trial, as assigned; escalates issues and recommends solutions to address concerns; with the guidance from the Director/Associate Director Clinical Operations/Senior Clinical Trial Manager.

KEY ROLE AND RESPONSIBILITIES:

• Conducts tasks related to the trial as assigned; escalates issues and recommends solutions to address concerns
• Develops tactical plans, detailed process steps and creates forms as needed for efficient trial execution; collaborates and seeks feedback from broader study team stakeholders to improve/optimize recommendations
• Responsible for oversight of defined tasks with CRO partners; ensures deliverables are conducted on a timely, quality basis. Raises issues quickly to CTM/Sr CTM for resolution; makes recommendations on how to address concerns
• Tracks inputs and deliverables day-to-day in partnership with the Clinical Operations team; identifies ways to improve the way we track study progress, reaches out to cross-functional partners for follow up and pull through.
• Collaborates effectively; operates as a mentor and subject matter expert for more junior clinical team members
• Supports TMF maintenance activities through timely filing of study and vendor documents, assisting with TMF review, reporting findings to CTM
• Continues to learn and apply ICH GCP guidelines; stays current with evolving expectations and applies new protocols as required; recommends processes and procedures that support effective trial management
• Tracks study expenses, as directed by Associate Director or Sr CTM, tracks vendor invoices, routes invoices for approval.

PREFERRED EDUCATION:

• BS in Life Sciences, or related discipline

PREFERRED EXPERIENCE:

• Minimum 4 years

KNOWLEDGE, SKILLS AND ABILITIES:

• Experience in Oncology clinical trial programs required
• Proven support of clinical studies for 2+ years; early phase and start-ups a plus
• Field/site monitoring experience a plus; sponsor in-house experience a plus, Oncology drug development experience a plus
• Track record of collaborating and managing CROs and other external vendors to deliver successful trial outcomes
• Operates effectively in cross-functional, multi-disciplinary teams
• Understands FDA regulations and ICH GCP guidelines; learns how to successfully apply these to studies to drive effective, efficient and timely strategies