Clinical Trial Manager

Role Overview

• Drives and Manages studies or projects according to scope of work, timelines, and quality standards.
• Supports building a strategy to deliver the trial or project as per protocol and timelines.
• Monitors and analyses project status to ensure successful completion of project parameters, milestones, timetables.
• Understands proactively manages risks on trials or projects and implements mitigations whilst working in a cross functional team.
• Acts as principal liaison between Sponsor and Care Access by facilitating the flow of information between Care Access and client.
• Appropriately escalates any issues or potential issues as per escalation pathways; and provides timely project updates to upline management and/or Senior Leadership at Care Access.
• Coordinates a cross functional team to support delivery of the clinical trial.
• Holds teams accountable for delivery and success of the trial.
• Leads teams to successfully deliver in their areas.
• Coordinates activities of all functional departments and vendors involved in the project.
• Works with team and management to develop plans/guidelines for project implementation using Care Access tools.
• Identifies data and analytics required to allows data-driven decisions and continuously monitors ongoing project performance.
• Evaluates growth opportunities of current engagement or potential engagements; helps develops the strategy for various initiatives.
• Works with team to identify potential risks, develop contingency plans.
• Plans and communicates to team members to study specific tasks and priorities for projects.
• Ensures that appropriate assessment and coordination of project/protocol specific and therapeutic area training needs and activities are occurring for the team members as needed.
• Maintains project logs and trackers.
• Supports essential documentation and follow up of monitoring visits
• Provides recommendations and alternative resolutions to project-specific challenges through established escalation channels.
• Ensures guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate.
• Escalates identified findings from periodic quality reviews and peer feedback reports.
• Collaborates with fellow CTMs and department leadership on best practices.
• Lead the process of study startup to support site evaluation/selection visits on each new study and help to have sites selected and successfully activated, based off of study requirements.
• Review study information and liaise with key stakeholders across the global organization to communicate study/site needs, requirements, performance expectations and establish timelines.
• Work closely with the staff onsite to help address questions, assess risks and mitigate issues throughout startup.
• Partner with other Care Access teams to initiate study related processes at the appropriate SSU milestone (e.g. capacity planning, systems build requests, etc.).
• Partner and communicate with client to drive startup activities, timelines, and expectations of Care Access startup process.
• Ensure that all information gained during the startup process is completely transitioned to sites, as required.
• Continue to assess and optimize study start up processes to enhance efficiency and productivity.
• Monitor key performance indicators to track progress and identify areas of improvement.
• Be main point of contact with the sponsor to drive study activation.

Requirements

• Must have clinical trial experience.
• Decentralized clinical trial experience, preferred.
• Site experience, preferably in a site network.
• PMP Certification, preferred.
• Bachelor's degree
• Must have 6+ years of experience in the clinical trial/pharmaceutical industry.
• Must have 4+ years in project management including client management.
• Must have 1-2 years strategy consulting experience.
• Experience with oversight of external vendors (e.g., e-consent vendor).
• Experience collaborating and leading cross-functional teams in a matrix environment.
• Experience managing multiple projects across various therapeutic areas.
• Experience anticipating and resolving problems on projects.
• Experience reporting project details to various stakeholders within the company and outside of the company

Tech Stack

• PMP

Benefits

• Paid Time Off (PTO) and Company Paid Holidays
• Medical, dental, and vision insurance plan options