Clinical Trial Manager

Key Responsibilities

• Accountable for project related efforts for the delivery of studies that are critical to a product’s clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.
• Supports external vendor selection and management process and assists in the development of RFP’s and vendor oversight plans.
• Responsible for management of CROs and other vendors.
• Provide input for the design of the Informed Consent Form(s), eCRFs, monitoring conventions, edit checks, etc.
• Develop timelines and budgets for assigned studies and is responsible for delivery to both quality and agreed timelines.
• Project leadership of the cross-functional study team, including external team members, CROs and vendors.
• Plan, negotiate, and manage site budgets as well as facilitate site contracting process.
• Develop and implement robust contingency and issue management plans to solve complex issues that impact study milestones.
• Disseminate clinical trial communications to all functional groups and leads study and team meetings.
• Interact with clinical research investigators, Key Opinion Leaders and sites.
• May interact with Senior Management to report on progress of milestones.
• Oversight of study team and site training
• Facilitation of Quality processes and Quality Assurance interactions for assigned project(s)
• Management of study drug distribution and accountability processes and documentation
• Oversight of study start-up, study management, data cleaning, and study closeout activities
• Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival
• Provides review, assistance or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms.

Qualifications

• BA/BS degree in Health or Life Sciences required
• Minimum 4+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role
• Exceptional communication and interpersonal skills
• Positive team orientated attitude
• Reliable, self-motivated, team player
• Detail oriented with excellent organizational skills
• Ability to effectively manage multiple tasks and competing priorities
• Creative problem solver
• Ability to travel is required
• CNS therapeutic experience strongly preferred

Pay

The expected salary range for this role is ($133,000 - $157,000) with the final offer based on experience, market data, and internal equity.