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REMS Project Manager

🔥 15 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

Where this job comes from

Posted on UBC's careers page, not through a job board

First seen by Remote Rocketship 15 hours ago

Still open on UBC's site. Checked 1 hour ago.

Logo of UBC

UBC

1001 - 5000 employees

Founded 2003

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

UBC is a company dedicated to improving patient outcomes by connecting specialty therapies to patients in need. They provide modern and customized solutions focusing on access, safety, and evidence generation for biopharmaceutical products. UBC specializes in evidence development, risk management, and patient access, utilizing real-world data and innovative technologies to optimize the healthcare journey and ensure effective medication use.

📋 Description

• 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, including clinical management, monitoring, training, communication, and compliance plans • Prepare project timelines and coordinate deliverables • Prepare meeting agendas, minutes, and action logs • Serve as UBC’s primary sponsor contact • Coordinate and facilitate internal and external project meetings • Resolve project team member questions • Supervise functional areas and cross-functional project teams • Ensure project training and assist with training • Develop content and lead internal and external kickoff meetings • Negotiate budgets and assist with contract-language remediation • Present project information at bid defenses, client meetings, and monthly project reviews • Maintain audit-ready project documentation • Participate in sponsor and regulatory audits as required • Coordinate investigator meetings as required • Assist with protocol development and patient/subject consent forms or REMS documentation as required • Lead process-improvement activities • Establish, implement, and track project and initiative metrics • Coordinate and maintain the Trial Master File as required • 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 • 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

🏖️ 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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