[Remote] Project Director, Evidence Development - RWE Clinical Trials

Note: The job is a remote job and is open to candidates in USA. UBC is a leader in the pharmaceutical support industry, focused on empowering health solutions and improving patient outcomes. The Project Director will provide leadership and oversight for project operations, financial performance, and client relationship management within the Evidence Development Solutions Department, ensuring successful project delivery and compliance with quality standards.ResponsibilitiesProvide strategic leadership, vision, and support to the project teams, ensuring alignment with the company's goals and client expectationsDrive PM performance, project quality delivery, milestone timeline adherence, financial margin optimization, and customer satisfaction through efficient and effective directorshipEnsure project teams prepare project plans to meet contracted services and timelinesEngage in UBC cross-functional interactions to address project needs and drive problem resolution; facilitate the involvement of Senior Management as necessaryAttend/participate in project internal / external meetings, and audits as neededLead and mentor multidisciplinary project teams, including Project Managers, Operations teams, vendors, and other functional staff, ensuring effective communication, collaboration, and performance of project deliverables according to contract termsWork with cross-functional managers to ensure projects are adequately staffed team members receive adequate training for specific job assignmentsSelect, contract, and manage external vendors and subcontractors, when necessary, while maintaining quality and cost-effectivenessMonitor delivery of projects per scope and budgets, and demonstrate strong oversight of financial health for assigned projectsOversee project budgets, resource expenditures, and effectively drive compliance with forecasting, invoicing, revenue recognition, out-of-scope management, and contract modificationsProactive, ongoing identification of project risks and development of mitigating strategies to minimize their impact on projects effectivelyEnsure development and maintenance of risk management plans and risk assessments and categorization toolsServe as the UBC senior operational contact with clients for all project related items, maintaining strong relationships, addressing their needs, and providing regular project updatesEnsure regular conduct of formal governance discussions to assess performance and drive issue resolutionImplement quality control measures to maintain the highest standards of data integrity, patient safety, and protocol complianceEnsure activities on projects are delivered with adherence to project Plans, company policies and/or sponsor’s SOPsBe familiar with and ensure that all projects adhere to relevant regulatory requirements, data privacy provisions, and international guidelines (e.g., FDA, EMA, EU Clinical Trials Directives, ICH-GCP, GDPR, HIPAA)Prepare, maintain, and deliver high quality project progress reports, metrics, and other outputs to clients and UBC senior managementEnsure that project specific tracking metrics are developed, consistent with scope of work and project timelinesOngoing review of available dashboards and reports for assigned projects to ensure adherence to all required activities and operational / financial performance indicatorsAssist, as directed, on specific business development opportunities: capabilities presentations, RFP review, proposals/budget input, bid defence participationWork with UBC Business Development to develop and grow UBC client relationships and maximum business opportunitiesAttend and present at conferences as requiredResponsible for the development, implementation, and project management process compliance for global projectsLead, innovate, and develop operational strategies that meet requirements and maximize project delivery successIdentify, develop, and implement improvements to UBC processes, quality, and overall project deliveryEngage in cross-functional collaborations with UBC leadership staff to optimize project deliveryContribute to UBC meetings, training activities, and cross-functional activities as appropriatePartake in ongoing assessment of project delivery resource needs, manage resource requests, and allocate staff to maintain target utilizations for rolesImplement creative resourcing solutions to maximize productivity and utilization of the teamManage the process of identifying/tracking staffing requirements and liaise with Human Resources regarding strategy, hiring, and onboarding project management resourcesIdentify and develop UBC process improvementsPrepare procedures, SOPs, guidelines and other standard materials for departmentEnsure staff are adequately trained on applicable SOPs, processes, and systemsEnsure timely completion of timesheets and expense reporting by assigned staffEnsure timely completion of required UBC and project specific training by assigned staffOther duties as assigned by UBC Senior LeadershipPD Oversight of 4 to 6 projects, depending on scopePD Oversight of 1 multi-study programs, depending on scopeDirect management of 1 to 2 projects, depending on scopeMentor, provide support, and direct supervision of Project Managers, Associate Project Managers, Project Associates, and other administrative staffConduct interviews for internal/external project management and operational candidatesConduct ongoing performance review of assigned staff and remediate deficienciesConduct annual employee performance evaluationsSkillsBachelor's degree in an appropriate discipline (Life Sciences, Healthcare, or Business) or equivalent industry experienceMinimum 12 – 15 years of clinical research operations experience, within in a CRO, pharmaceutical, device/diagnostics or biotechnology companyMinimum 10 years of experience at increasing levels of project management or clinical research oversight responsibilitiesMinimum 5 years supervisory/management experienceProven ability to lead, motivate, and manage cross-functional teamsStrong understanding and experience in operational clinical operations and overall drug/biologic development processesStrong knowledge of functional components of clinical drug development (e.g., clinical, data management, statistics and medical writing)Comprehensive knowledge of ICH GCP and applicable international regulations (EU Clinical Trials Directives, FDA Guidelines, etc.)Excellent understanding of and experience managing evidence development projects (e.g., Phase IV studies, RWE, Ph II – III clinical trials, expanded access programs, etc.) globallyAbility to drive operational strategy for global evidence development programsExperience with proposal and budget development for evidence development programsClient focused with strong leadership skillsStrong verbal, written, and interpersonal communication skillsStrong prioritization, time management, and project management skillsStrong negotiation, influencing, consensus building, and relationship management skillsStrong innovative, analytical, problem-solving and decision-making skillsStrong financial acumen and budget management experienceStrong computer skills including MS OfficeProficiency in project management tools and softwareResults driven and team-oriented, with the ability to influence outcomes as necessaryDemonstrated ability to manage staff to achieve company and client goalsAbility to handle multiple tasks in a fast-paced, deadline oriented environment10% travel availabilityAdvanced degree (Master's or Ph.D.) preferredPrevious history as a Project Director or Director of Clinical Operations (related) within a CRO preferredBroad therapeutic experience a plusBenefitsCompetitive salariesGrowth opportunities for promotion401K with company match*Tuition reimbursementFlexible work environmentDiscretionary PTO (Paid Time Off)Paid HolidaysEmployee assistance programsMedical, Dental, and vision coverageHSA/FSATelemedicine (Virtual doctor appointments)Wellness programAdoption assistanceShort term disabilityLong term disabilityLife insuranceDiscount programsCompany OverviewUnited BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access. It was founded in 2003, and is headquartered in Bethesda, Maryland, USA, with a workforce of 1001-5000 employees. Its website is http://ubc.com.Company H1B SponsorshipUBC has a track record of offering H1B sponsorships, with 5 in 2025, 3 in 2024, 3 in 2023, 4 in 2022, 5 in 2021, 2 in 2020. Please note that this does not guarantee sponsorship for this specific role.