Sr. Clinical Project Research Manager - Global Clinical Oncology

United Biosource Corporation•All Virtual Locations, Home Based Position, USA, Remote, US,

2d•Remote

About The Position

The Senior Clinical Project Research Manager leads UBC project teams to deliver 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 applicable company and project-specific SOPs, guidelines, budgets, timelines, and contracts. It executes operational project activities, helps develop study and regulatory deliverables, and ensures operational plans are established, followed, and monitored against project needs. The position leads cross-functional clinical projects, oversees supporting functional areas, and supervises project management staff and other team members. It is accountable for timely and accurate deliverables, sponsor progress reporting, project budget tracking, contracted services and milestones, project documentation readiness, and accurate reporting and interpretation of metrics. The manager also supports project training, investigator meetings, client proposals, audits, process improvement, and issue resolution, and may assist with protocol, consent form, and REMS-related development. The expected project load is two to three projects, depending on scope. Travel is 10%.

Requirements

Bachelor of Arts degree or a minimum of 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, interpersonal, and presentation skills.
Ability to independently assess issues and mitigate risk using critical judgment to reach a resolution.
Solution-driven approach and 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 study start-up through close-out.
Execute operational aspects of assigned project activities and special projects.
Assist with development and design of protocols, CRFs, regulatory documents, project master files, and other project deliverables.
Develop and monitor operational plans, including communication, monitoring, project, training, compliance, and clinical management plans, and ensure compliance with established 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, timely delivery of project deliverables and timelines; report project progress to sponsors.
Lead cross-functional projects and supervise functional areas supporting the project.
Assist with project revenue and invoicing.
Ensure project training occurs and assist with training as assigned.
Serve as a resource to team members for inquiries and issue resolution involving site management, contract budgets and remediation, and regulatory document preparation.
Lead internal client teleconferences and meetings and present project information at client meetings, bid defenses, and UBC monthly project review meetings.
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 and prepare PMs to present and defend proposals to clients.
Track project budgets against contract milestones.
Assist with protocol development and/or patient/subject consent forms or REMS and REMS supporting documents as required.
Initiate and lead process improvement activities; interpret and report project metrics and propose and implement action plans.
Ensure satisfactory delivery of contracted services and achievement of contracted milestones.
Supervise project management staff, ensure APMs/PMs understand client needs, mentor them in daily activities, help anticipate and resolve project issues, and foster teamwork.
Perform Project Manager duties and other duties assigned by management.