Clinical Trial Manager

Care Access

19h•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. This role is critical to operationalize trials or projects across the organization and site network within Care Access Research.

Requirements

Must have clinical trial experience.
Bachelor's degree
Must have 5+ years of experience in the clinical trial/pharmaceutical industry.
Must have 2-3+ years in project management including client management.
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
Exceptional strategic thinking and problem-solving skills to drive Care Access goals while fostering and maintaining a strong client relationship.
Effective leadership skills, strong communication competency, and proven ability to foster team productivity and cohesiveness.
Ability to show flexibility by pivoting workflows and adjusting priorities as needed.
Ability to work independently, organize work with attention to detail and accuracy; demonstrated skill in assessing timelines and coordinating numerous assignments and projects simultaneously under heavy and fluctuating workloads and conflicting deadlines.
High degree of discretion in dealing with confidential information.
Ability and willingness to work flexible hours when needed.
Ability to mentor junior team members.
Excellent written, verbal, and interpersonal communication skills.
Comfortable in a fast-paced environment.

Nice To Haves

Decentralized clinical trial experience, preferred.
Site experience, preferably in a site network.
PMP Certification, preferred.
Experience with strategy consulting, preferred.
Experience with oversight of external vendors (e.g., e-consent vendor).

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.
Ensures teams are entering and updating internal tracking tools.
Works with team to identify potential risks, develop contingency plans.
Provides Sponsor with timely project updates, ensures correct protocol interpretations, and obtains direction and feedback on implementing scope of work.
May discuss and obtain feedback from Sponsors regarding Care Access’s performance to date.
Plans and communicates to team members to study specific tasks and priorities for projects.
Delegates, as appropriate, assigned responsibilities to project team members.
Liaises with managers in all functional areas within Care Access to optimize performance and utilization of the project team members.
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.
Schedules, leads, and follows up on pre-identified meetings. Documents, sends meeting minutes and follows-up on action items. May be internal and/or external.
Maintains project logs and trackers.
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.