REMS Project Manager
- Experience Level
- Experienced (non-manager)
*This REMS Project Manager will support our REMS business.
*This is a remote opportunity.
Job Title: YLM01H – Clinical Project Research Manager
Brief Description: Plan, organize and lead UBC project teams to deliver projects based on client needs on time, on budget, and within scope.
Specific Job Duties:
- Oversee all aspects of project conduct from start-up through close-out
- Execute operational aspects of assigned project activities as well as special projects
- Manage project per the scope of work and within the contracted budget
- Manage revenue and invoicing for project(s)
- Ensure project is conducted according to UBC SOPs and client SOPs as applicable
- Develop plans and processes to achieve contracted milestones (e.g. project plan, clinical management plan, monitoring plan, training plan, communication plan, compliance plan); monitor project progress against the established plans and ensure compliance with plans
- Prepare project timelines and prepare or coordinate development of deliverables
- Prepare project meeting agendas and create minutes and actions logs
- Ensure project budget is tracked against contract milestones
- Serve as UBC primary contact with sponsor
- Coordinate and facilitate all project meetings with internal and external stakeholders as necessary
- Focal point for resolving project team member questions
- Supervise all functional areas that support the project
- Lead projects with cross functional involvement and supervise all functional areas that support the project
- Ensure project training occurs and assist with training for project, as assigned
- Develop content and lead Kick off Meetings both internally and externally
- Negotiate budgets and assist with remediation of contract language
- Present project information at bid defenses, client meetings and UBC monthly project review meetings
- Maintain project documentation to be “audit ready”
- Participate in sponsor/regulatory audits as required
- Coordinate investigator meeting as required
- May be asked to assist in protocol development and/or patient/subject consent form or REMS and REMS Supporting Documents as required
- Help lead process improvement activities
- Establish, implement and track key metrics to report on progress of project and initiatives
- Coordinate and ensure maintenance of Trial Master File as required
- May be asked to perform CSS and CRA duties as needed
- Other duties as assigned by management
Supervisory Responsibility: Supervision of project team
Desired Skills and Qualifications:
- Bachelor’s Degree or equivalent experience
- Previous managerial, or relevant experience, required
- Very good written verbal and non-verbal communication skills
- Very good supervisory skills
- Very good interpersonal skills
- Very good presentation skills
- Ability to independently assess issues and/or mitigate risk by using critical judgment to come to a resolution
- Solution driven
- Very good knowledge of regulatory requirements (i.e. Good Clinical Practice, ICH guidelines, etc.)
- 10% travel as required
UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.
United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety.
While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.
Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.
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