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Director, Clinical Research – REMS, BioPharma

Clinical ResearchClinical ResearchFull TimeRemoteLeadTeam 1,001-5,000Since 2003H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

9 days ago

Salary

0

Seniority

Lead

Bachelor DegreeEnglish

Job Description

Director, Clinical Research – REMS, BioPharma

UBC

• 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.

Job 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

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