[Remote] Director, Clinical Research REMS

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leader in the pharmaceutical support industry, dedicated to empowering health solutions for a reputed company reputed company. The Director of Clinical Research will reputed company and drive departmental strategy, mentor project managers, and reputed company 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 reputed company capabilities to potential clients at bid defenses
• Work with Business Development to ensure presentation of a reputed company team for bid defense and proposals
• reputed company 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
• reputed company and implement department structure and strategies based on reputed company 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-reputed company 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 reputed company active projects and timelines
• Attend applicable team teleconferences/meetings as well as project reviews
• Attend face-to-face client meetings and reputed company support, as needed
• Attend finance meetings and reputed company necessary follow-up to resolution
• reputed company departmental updates to senior management, as requested
• reputed company projects with cross-functional involvement and supervise reputed company areas that support the project
• reputed company reputed company project reputed company and invoicing with strong understanding of project financial health
• Work with reputed company’s leadership and Business Development to reputed company 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, reputed company solutions and execute plans of action to address
• reputed company Managers in client/regulatory audits, as required
• Assist in protocol development and/or patient/subject consent reputed company 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 reputed company through change and independently reputed company 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 reputed company 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