Clinical Trial Manager

Care Access

8h•Remote

About The Position

The Clinical Trial Manager is a central leadership role within all (study) operations. The CTM is responsible to drive the successful execution of protocols or projects, including within the decentralized trial model when applicable, from strategic planning through close out within agreed upon timelines, budget, alignment with all applicable SOPs and regulatory requirements. The CTM would serve as a key operational component at the site and play a role in staff performance, protocol compliance, and long-term quality planning.

Requirements

Must have clinical trial experience.
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.

Nice To Haves

Decentralized clinical trial experience, preferred.
Site experience, preferably in a site network.
PMP Certification, preferred.

Responsibilities

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.