Note: The job is a remote job and is open to candidates in USA. UBC is a leader in the pharmaceutical support industry, dedicated to empowering health solutions for a better tomorrow. The Director of Clinical Research will develop and drive departmental strategy, mentor project managers, and oversee project management activities to ensure successful project delivery.
Responsibilities
- 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, with 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 a 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 updates 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 plans 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
Skills
- 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
- 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
- Advanced computer skills
- Advanced Degree preferred
- Broad therapeutic experience a plus
- European/Global experience a plus
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
Company Overview
Company H1B Sponsorship