REMS Senior Project Manager

United Biosource Corporation• Remote, US,

4d•Remote

About The Position

The Senior Clinical Project Research Manager leads UBC project teams in delivering project milestones and serves as the primary sponsor contact for study-related matters. The role oversees study conduct from start-up through close-out in accordance with company and project-specific SOPs, guidelines, budgets, timelines, and contracts, and executes operational activities for assigned projects and special projects. The manager leads cross-functional project teams, supervises and mentors APMs, PMs, and other team members, and ensures project deliverables, timelines, training, and documentation are handled accurately and on time. The role tracks project progress, metrics, budgets, and contracted milestones; communicates progress to sponsors; supports client proposals and meetings; and contributes to process improvement and issue resolution. The position may also support development of protocols, consent forms, REMS, and REMS supporting documents. The expected project load is two to three projects, depending on scope. Travel is 10%.

Requirements

Bachelor of Arts degree or at least 5 years of direct project management experience at a CRO, or proven leadership/management experience.
Excellent written, verbal, and non-verbal communication skills.
Excellent supervisory skills.
Excellent interpersonal skills.
Excellent presentation skills.
Ability to independently assess issues and mitigate risk using critical judgment to reach resolutions.
Solution-driven approach.
Ability to manage competing priorities effectively.
Very good knowledge of regulatory requirements, including Good Clinical Practice and ICH guidelines.
Ability to travel 10%.

Responsibilities

Serve as the primary sponsor contact for study-related matters and oversee project conduct from start-up through close-out.
Execute operational activities for assigned projects and special projects.
Assist with development of protocols, CRFs, regulatory documents, project master files, and other project deliverables.
Develop or coordinate operational plans, including communication, monitoring, project, training, compliance, and clinical management plans; monitor progress and compliance against those plans.
Plan and facilitate investigator meetings, recruit qualified investigators, and assist with budget negotiations as needed.
Supervise APMs, PMs, and other team members to ensure accurate and timely deliverables; report project progress to sponsors.
Lead cross-functional projects and supervise the functional areas supporting each project.
Assist with project revenue and invoicing.
Ensure project training occurs and provide training as assigned.
Serve as a resource for team inquiries and issue resolution involving site management, contract budgets and remediation, and regulatory document preparation.
Lead internal and client teleconferences and meetings, and present project information at client meetings, bid defenses, and UBC monthly project reviews.
Maintain project documentation in audit-ready condition and support APMs/PMs during sponsor or regulatory audits as required.
Assist in preparing client proposals in response to RFPs.
Track project budgets against contract milestones.
Assist with protocol development and/or patient or subject consent forms, REMS, and REMS supporting documents as required.
Initiate and lead process improvement activities; accurately report and interpret project metrics and propose and implement action plans.
Ensure satisfactory delivery of contracted services and achievement of contracted milestones.
Perform Project Manager duties and other duties assigned by management.
Supervise project management staff in execution of assigned projects.
Prepare PMs to present and defend proposals, and ensure APMs/PMs understand client needs after project award.
Mentor APMs/PMs, help anticipate and resolve project issues, foster teamwork, and maintain a positive attitude.