UBC

Director, Clinical Research – REMS

UBC

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Lead

About the role

  • Manage projects as needed
  • Work with Managers and Project Directors to ensure projects are adequately staffed; monitor workloads and adjust as needed
  • Assist, as directed, specific project opportunities in Business Development, RFP review and completion, and bid defense preparation and delivery
  • Present UBC capabilities to potential clients at bid defenses
  • Work with Business Development to ensure presentation of qualified team for bid defense and proposals
  • Provide input into proposals and review budgets
  • Ensure performance of project deliverables according to contract terms and company quality expectations, including accurate reporting and interpretation of metrics
  • Ensure project team members receive adequate training for specific job assignments
  • Develop and implement department structure and strategies based on current staffing and project needs
  • Ensure adherence to project Plans, company policies and/or sponsor’s SOPs
  • Work with staff (as needed) to plan and organize project activities
  • Ensure teams have consistency with completion of job-related tasks
  • Work closely with Managers and project teams to resolve operational issues
  • Report and discuss departmental, personnel and/or site issues with Senior Management, as needed, for possible resolutions
  • Conduct performance appraisals if assigned direct reports
  • Conduct staff interviews; assist with CV candidate review
  • Working knowledge of all active projects and timelines
  • Attend applicable team teleconferences/meetings as well as project reviews
  • Attend face to face client meetings and provide support, as needed
  • Attend finance meetings and perform necessary follow-up to resolution
  • Provide departmental update to senior management, as requested
  • Lead projects with cross-functional involvement and supervise all areas that support the project
  • Oversee all project revenue and invoicing with strong understanding of project financial health
  • Work with UBC’s leadership and Business Development to develop and grow client relationships and business to maximum potential
  • Proactively serve as a resource and mentor to Project Managers and teams for problem resolution; facilitate the involvement of Senior Management as necessary
  • Proactively identify areas of improvement, provide solutions and execute plan of action to address
  • Lead Managers in client/regulatory audits, as required
  • Assist in protocol development and/or patient/subject consent form or REMS and REMS Supporting Documents, as required
  • Other duties as assigned by management
  • Direct project supervision of multiple Managers, including development of Managers in presentation and bid defenses, proposal and implementation of action plans, and ensuring Managers have a clear understanding of client needs once a project is awarded
  • Responsible for direct reports in addition to supervision of multiple Managers and projects as assigned, if assigned direct reports
  • Serve as a resource and mentor to the Managers in their daily activities
  • Proactively assist the Managers in anticipating and seeking resolutions to potential and actual project issues
  • Motivate project team members by fostering teamwork
  • Maintain positive attitude
  • Ability to plan and forecast potential issues, outcomes, and changes necessary to ensure program and developmental success
  • Ability to identify and optimize resources, inclusive of knowing when to identify and/or assign additional/or different resources

Requirements

  • Advanced Degree preferred, bachelor’s degree or equivalent experience required
  • Extensive project management experience at a CRO or proven leadership/management experience managing multiple projects and project teams (additional or other relevant management experience may be considered)
  • Strong knowledge of FDA/ICH regulatory guidelines; only applicable for Europe if required
  • Working knowledge of functional components of clinical drug development (e.g., clinical, data management, statistics and regulatory/medical writing)
  • Mastery of project management skills with the ability to lead through change and independently lead multiple large projects simultaneously
  • Solid problem-solving and analytical skills with willingness and ability to detect process gaps, challenge assumptions, and drive change and improvement
  • Ability to work in a team environment under high-pressure situations
  • Excellent interpersonal, written, and verbal communication skills
  • Proven ability to interpret and prioritize customer needs
  • Strong influencing and negotiation skills
  • Takes initiative and is results and detail oriented
  • Ability to build strong business relationships across various departments
  • Broad therapeutic experience a plus
  • 10% travel as required
  • Extensive knowledge of Clinical Trial Monitoring, as required
  • Clinical background or equivalency in clinical research experience, as required
  • Proven knowledge of medical terminology
  • European/Global experience a plus
  • Advanced computer skills
Benefits
  • Remote opportunities
  • Competitive salaries
  • Growth opportunities for promotion
  • 401K with company match
  • Tuition reimbursement (after 90 days of employment)
  • 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 (after 90 days of employment)
  • Long-term disability
  • Life insurance
  • Discount programs
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
project managementclinical trial monitoringclinical drug developmentFDA regulatory guidelinesICH regulatory guidelinesdata managementstatisticsregulatory writingmedical terminologybudget management
Soft Skills
leadershipproblem-solvinganalytical skillsinterpersonal skillscommunication skillsinfluencing skillsnegotiation skillsteamworkinitiativedetail-oriented
Certifications
Project Management Professional (PMP)Certified Clinical Research Associate (CCRA)Certified Clinical Research Coordinator (CCRC)Advanced degree in relevant field