Director, Clinical Research - REMS Project Management

United Biosource Corporation

20d•Remote

About The Position

As a pharmaceutical support industry leader, UBC is devoted to empowering health solutions for a better tomorrow. We take pride in improving patient outcomes and advancing healthcare. At UBC we provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation. Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in an inclusive workplace that fosters creativity. If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!

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
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

Nice To Haves

Broad therapeutic experience a plus
European/Global experience a plus
Advanced computer skills

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, 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.