Clinical Project Research Manager – EDS, RWE, NIS
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Job Description
Clinical Project Research Manager leading pharmaceutical clinical and real-world evidence projects at UBC. Managing cross-functional teams, budgets, milestones, compliance, and sponsor relationships.
Responsibilities:
- Plan, organize, and lead UBC project teams to deliver projects based on client needs on time, on budget, and within scope
- 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 scope of work and contracted budget
- Manage project revenue and invoicing
- Ensure projects follow UBC and applicable client SOPs
- Develop project plans and processes to achieve contracted milestones
- Monitor project progress and compliance against established plans
- Prepare project timelines and coordinate deliverables
- Prepare meeting agendas, minutes, and action logs
- Track project budgets against contract milestones
- Serve as UBC’s primary sponsor contact
- Coordinate project meetings with internal and external stakeholders
- Resolve project team member questions
- Supervise functional areas supporting projects
- Lead cross-functional projects
- Ensure and assist with project training
- Develop and lead internal and external kick-off meetings
- Negotiate budgets and assist with contract remediation
- Present project information at bid defenses, client meetings, and monthly project reviews
- Maintain audit-ready project documentation
- Participate in sponsor/regulatory audits
- Coordinate investigator meetings
- Assist with protocol development and patient/subject consent forms or REMS documents as required
- Lead process improvement activities
- Establish, implement, and track key project metrics
- Coordinate maintenance of the Trial Master File
- Perform CSS and CRA duties as needed
- Perform other duties assigned by management
- Supervise the project team
Requirements:
- Bachelor’s Degree or equivalent experience
- Previous managerial, or relevant experience, required
- Excellent written verbal and non-verbal communication skills
- Excellent supervisory, interpersonal, and presentation skills
- Ability to independently assess issues and/or mitigate risk by using critical judgment to come to a resolution
- Solution driven
- Knowledge of regulatory requirements (i.e. Good Clinical Practice, ICH guidelines, etc.)
- 10% travel as required
Benefits:
- Remote opportunities
- Competitive salaries
- Growth opportunities for promotion
- 401K with company match
- Tuition reimbursement
- Flexible work environment
- Discretionary Time Off
- Paid Holidays
- Employee assistance programs
- Medical, Dental, and vision coverage
- HSA/FSA
- Telemedicine (Virtual doctor appointments)
- Wellness program
- Adoption assistance
- Short term disability
- Long term disability
- Life insurance
- Discount programs
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