REMS Project Manager

🔥 7 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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UBC

WebsiteLinkedInAll Job Openings

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 plans and processes to achieve contracted milestones, including project, clinical management, monitoring, training, communication, and compliance plans • 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 and facilitate internal and external project meetings • Resolve project team member questions • Supervise functional areas supporting projects and cross-functional project teams • Ensure project training occurs 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 • Coordinate investigator meetings • Assist with protocol development, patient/subject consent forms, REMS, and REMS Supporting Documents as required • Help lead process improvement activities • Establish, implement, and track key project and initiative metrics • Coordinate and ensure 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 • 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