Senior Project Manager
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Job Description
Senior Project Manager leading REMS and clinical research projects for UBC, a pharmaceutical support services company. Overseeing sponsors, cross-functional teams, regulatory deliverables, budgets, and milestones.
Responsibilities:
- Lead UBC project teams to deliver project milestones
- Serve as the primary sponsor contact for study-related items
- Oversee project conduct from study start-up through close-out according to SOPs, guidelines, budgets, timelines, and contracts
- Execute operational aspects of assigned projects and special projects
- Assist with protocols, CRFs, regulatory documents, project master files, and other deliverables
- Develop and monitor communication, monitoring, project, training, compliance, and clinical management plans
- Plan investigator meetings, recruit investigators, and assist with budget negotiations
- Supervise APMs, PMs, and other team members to ensure accurate and timely deliverables
- Lead cross-functional projects and supervise supporting functional areas
- Assist with project revenue and invoicing
- Ensure project training occurs and assist with training
- Support site management, contract budget and remediation, and regulatory document preparation
- Lead internal and client meetings, bid defenses, and project review meetings
- Maintain audit-ready project documentation
- Support sponsor/regulatory audits
- Assist with client proposals responding to RFPs
- Track project budgets against contract milestones
- Assist with protocol, patient/subject consent form, REMS, and REMS supporting document development as required
- Initiate and lead process improvement activities
- Report and interpret project metrics
- Propose and implement action plans
- Deliver contracted services and achieve contracted milestones
- Mentor and support APMs/PMs in daily activities, client presentations, issue resolution, and project execution
- Motivate project team members and foster teamwork
Requirements:
- 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.)
- 10% travel
- Supervisory/project management experience in a CRO or proven leadership/management experience
Benefits:
- Remote opportunities
- Competitive salaries
- Growth opportunities for promotion
- 401K with company match
- Tuition reimbursement
- Flexible work environment
- Discretionary PTO (Paid 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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