Clinical Project Research Manager – EDS, RWE, NIS
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Job Description
Clinical Project Research Manager leading UBC pharmaceutical clinical and real-world evidence projects. Managing cross-functional teams, budgets, sponsors, regulatory compliance, and Trial Master File activities.
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 and monitor project plans and processes for contracted milestones
- Prepare project timelines and coordinate deliverables
- Prepare meeting agendas and create minutes and action logs
- Track project budgets against contract milestones
- Serve as primary UBC contact with sponsors
- Coordinate and facilitate internal and external project meetings
- Resolve project team member questions
- Supervise cross-functional project support areas
- Ensure project training and assist with training
- Develop content and lead internal and external kickoff 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 project metrics
- Coordinate and maintain 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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