Clinical Project Research Manager - EDS/RWE/NIS

United Biosource Corporation• Remote, US,

5d•Remote

About The Position

The Clinical Project Research Manager plans, organizes, and leads UBC project teams to deliver projects according to client needs, on time, within budget, and within scope. The role oversees project conduct from start-up through close-out, manages contracted scope, budget, revenue, invoicing, timelines, deliverables, and project documentation, and ensures compliance with applicable UBC and client SOPs and established plans. The manager serves as UBC’s primary sponsor contact and leads coordination among internal and external stakeholders. The position supervises project teams and supporting functional areas, organizes meetings and training, tracks project progress and metrics, supports audits and Trial Master File maintenance, and may assist with protocol and consent-form development, REMS materials, or CSS and CRA duties. The role may also involve budget negotiations, contract-language remediation, process improvement, and presentations to clients and internal review meetings. Travel of 10% is required as needed.

Requirements

Bachelor’s degree or equivalent experience.
Previous managerial or relevant experience.
Excellent written, verbal, and non-verbal communication skills.
Excellent supervisory, interpersonal, and presentation skills.
Ability to independently assess issues and mitigate risk using critical judgment to reach a resolution.
Solution-driven approach.
Knowledge of regulatory requirements, including Good Clinical Practice and ICH guidelines.
Ability to travel 10% as required.

Responsibilities

Oversee all aspects of project conduct from start-up through close-out.
Execute operational aspects of assigned project activities and special projects.
Manage projects according to the scope of work and contracted budget, including revenue, invoicing, and budget tracking against contract milestones.
Ensure projects follow UBC and applicable client SOPs.
Develop and monitor plans and processes for achieving contracted milestones, including project, clinical management, monitoring, training, communication, and compliance plans.
Prepare project timelines and prepare or coordinate development of deliverables.
Prepare meeting agendas and create meeting minutes and action logs.
Serve as UBC’s primary contact with the sponsor.
Coordinate and facilitate project meetings with internal and external stakeholders.
Address project team member questions and supervise functional areas supporting the project.
Lead cross-functional projects and ensure project training occurs; assist with training as assigned.
Develop content for and lead internal and external kick-off meetings.
Negotiate budgets and assist with contract-language remediation.
Present project information at bid defenses, client meetings, and UBC monthly project review meetings.
Maintain project documentation in audit-ready condition and participate in sponsor or regulatory audits as required.
Coordinate investigator meetings as required.
Assist with protocol development, patient or subject consent forms, REMS, and REMS supporting documents as required.
Help lead process-improvement activities and establish, implement, and track key project and initiative metrics.
Coordinate and ensure maintenance of the Trial Master File as required.
Perform CSS and CRA duties as needed.
Perform other duties assigned by management.