Sr Clinical Project Research Manager

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

11h•Remote

About The Position

UBC is seeking an experienced Sr. Clinical Project Research Manager with 5 years of experience managing global clinical trials within the CRO industry. This person must have observational study experience. Oncology experience is preferred. UBC is a pharmaceutical support industry leader, devoted to empowering health solutions for a better tomorrow. We take pride in improving patient outcomes and advancing healthcare. At UBC, we provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation. UBC fosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in an inclusive workplace that fosters creativity.

Requirements

5 years of experience managing global clinical trials within the CRO industry
Observational study experience
BA Degree or minimum 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/or mitigate risk by using critical judgment to come to a resolution
Solution driven
Manage competing priorities effectively
Very good knowledge of regulatory requirements (i.e. Good Clinical Practice, ICH guidelines, etc.)

Nice To Haves

Oncology experience is preferred

Responsibilities

Serve as the primary contact with the sponsor for all study related items, with oversight of all aspects of project conduct, from study start-up through close-out in accordance with company and project specific SOPs, guidelines, budgets, timelines and contracts
Execute operational aspects of assigned project activities as well as special projects
Assist in the development and design of protocols, CRFs, regulatory documents, project master file, and other project related deliverables
Ensure operational plans are developed consistent with project needs, including but not limited to, the development of communication plans, monitoring plans, project plans, training plan, study timelines, Compliance Plan and clinical management plans; monitor project progress as compared to established plans and ensure compliance with plans
Facilitate and plan investigator meetings; recruit qualified investigators and assist in budget negotiations as required
Supervise APM/PMs and other team members to ensure project deliverables and timelines are delivered accurately and timely; provide reports to the Sponsor on project progress
Lead projects with cross functional involvement and supervise all functional areas that support the project
Assist in revenue and invoicing for project(s)
Supervise all functional areas that support the project
Ensure project training occurs and assist with training for project, as assigned
Serve as a resource to team members for all inquiries and issue resolution for site management, contract budget and remediation, and regulatory document preparation
Lead internal client teleconferences and/or meetings and present project information at client meetings, bid defenses and UBC monthly project review meetings
Maintain project documentation to be “audit ready”
Support APM/PMs in sponsor/regulatory audits as required
Assist in preparation of client proposals in response to RFPs
Ensure project budget is tracked against contract milestones
May be asked to assist in protocol development and/or patient/subject consent form or REMS and REMS Supporting Documents as required
Initiate and lead process improvement activities
Accurate reporting and interpretation of project metrics
Proposal and implementation of action plans
Satisfactory delivery of contracted services and achievement of contracted milestones for assigned projects
Duties described for Project Manager and other duties as assigned by management
Supervision of project management staff in execution of assigned projects
Prepare PMs to make presentations to clients in defense of proposals
Ensure that the APM/PM understands the client needs once a project is awarded
Serve as a resource and mentor to the APM/PM in the execution of their daily activities
Proactively assist the APM/PM in anticipating and seeking resolutions to potential and actual project issues
Motivate project team members by fostering teamwork
Maintain positive attitude