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Collaborates with CSO on global investigational product [IP] supply forecasting/management.</li><li>Participates in the subject recruitment/retention strategy and related initiatives (e.g. recruitment material).</li><li>Participates in clinical service provider (vendor) selection, specification development, and management / oversight.</li><li>Oversees TMF set-up, ongoing quality review, and operational oversight memo and requests final reconciliation</li><li>Oversees eCOA activities throughout the lifecycle of the study.</li><li>Provides input to and reviews study training for Study Team, investigational sites, and vendors in collaboration with the Clinical Scientist.</li><li>Oversee study specific CSR appendices.</li><li>Provides input and communicates with the appropriate teams for response to country/regulatory and IRB/IEC.</li><li>Promptly shares information with key internal/external stakeholders at regular meetings.</li><li>Proactively identifies and anticipates issues and risks and oversees the creation of mitigation plans and implements resolutions.</li><li>Oversees service providers with minimal supervision.</li><li>Leads Audit Response Team and CAPA and participates in inspections.</li><li>Supports the development/management/review of the vendor scope of work (SOW), invoices, accruals as per the contract, quality requirements, and budget.</li><li>Study Planning and Conduct – Outsourced Studies</li><li>Reviews/approves functional plans (e.g. SAE management plan, PSV waivers, BMS confidentiality agreement for sites with master agreements with BMS). Provides information to the CRO and reviews CRO deliverables.</li><li>Sets up and maintains Protocol Level training curriculum in SuccessFactors.</li><li>Reviews Protocol Level training for IM and SIV.</li><li>Owns overall and end-to-end study project management responsibilities.</li><li>Provides oversight and reviews all outsourced activities (protocol to CSR) in Clinical Pharmacology (NHV) studies.</li></ul><p><strong>Relationship Management:</strong></p><ul><li>Proactively develops/maintains collaborative relationships with internal partners/stakeholders across the multidisciplinary teams.</li><li>Manages external partners including Contract Research Organizations (CROs), Academic&nbsp;</li><li>Research Organizations (AROs), and other clinical service providers as applicable.</li><li>Ensures appropriate methods are used when communicating with key stakeholders and &nbsp;cross functional partners.</li></ul><p><strong>Leadership Competencies:</strong></p><ul><li>Creates realistic plans that clearly define goals, milestones, responsibilities, and results.</li><li>Maintains focus on strategic objectives while accomplishing operational goals.</li><li>Places a priority on getting results with an emphasis on high quality outcomes.</li><li>Holds self and others accountable for accomplishing goals.</li><li>Makes timely, data-driven decisions while balancing against daily priorities.</li><li>Develops and maintains effective working relationships with people across cultures.</li><li>Incorporates global considerations in everyday decision-making.</li><li>Encourages collaboration across teams, functions, and geographies.</li><li>Ensures that conflict is handled constructively so that performance is not impacted.</li><li>Displays a willingness to challenge the status quo and take risks.</li><li>Responds resourcefully to changing business demands and opportunities, proactively looking for ways the team can contribute.</li><li>Maintains optimism and composure in times of change, uncertainty, or stress.</li><li>Executes to deliver on corporate objectives.</li><li>Acts as a mentor for the Study Team and function.</li><li>Supports development of GDO best practices.</li><li>Actively manages team behavior by mediating internal disputes, promoting energy/commitment, and recognizing and rewarding accomplishments. Seeks opportunities for continued learning as to how strategy is shaped in the organization</li></ul><p><strong>Key Competency Requirements</strong></p><p><strong>Technical Competencies:</strong></p><ul><li>Clinical trial project management skills.</li><li>Financial budgeting and forecasting skills are a plus.</li><li>In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes.</li><li>Proven success in using oral/written communication skills to influence, inform, or guide others.</li><li>Computer skills - Microsoft applications including (but not limited to), Word and Excel and PowerPoint</li><li>Proficiency in study tools including electronic system skills – e.g. CTMS/eTMF.</li><li>Demonstrated project management and organizational skills with strong presentation and communication abilities.</li><li>Ability to manage multiple deliverables and nimbly respond to changing business demands.</li></ul><p><strong>Management Competencies:</strong></p><ul><li>Understands interdependencies, links possible solutions, and escalates issues with proposed solutions to appropriate people.</li><li>Reacts with a sense of urgency and responds appropriately.</li><li>Critical thinking skills for problem solving and the lateral and strategic thinking capacity to drive the study(ies) and understanding the upstream, downstream and lateral implications of decisions that affect study outcomes and timelines.</li><li>Leverages interpersonal and influencing skills to foster partnerships across multidisciplinary teams.</li></ul><p><strong>Degree Requirements:</strong></p><ul><li>BA/BS or equivalent degree in relevant discipline Experience Requirements</li><li>Minimum 4 years of demonstrated project management experience of which at least 2 should have been in the pharmaceutical or healthcare industry.</li><li>Experience in leading global clinical trials and multi-functional teams.</li><li>Demonstrated project management and organizational skills with strong presentation and communication abilities.</li><li>Experience with electronic quality, compliance and CTMS systems. 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