Clinical Project Manager, Medical Affairs (Remote)

Job Description Summary Reporting to the MMS Medical Affairs Evidence Generation leader, the Clinical Project Manager is responsible for Human Subject Research trial management (clinical, non-clinical, and administrative functions) of multiple studies and may be subject matter expert for group or platform of assigned clinical studies including the planning, implementation, oversight, project... management and completion of Human Subject Research (clinical and non-clinical) conducted by Medication Management Solutions (MMS) Medical Affairs or Contract Research Organization (CRO), if applicable. This role as the project lead for studies of moderate to high complexity, from protocol development through study conduct and closeout in compliance with Good Clinical Practices, and all Global, National, and Local Regulations, collaborates with the Health Economics and Outcomes Research team, Data Analysts, and other members of the MMS Medical Affairs team to evaluate and/or develop early plans and concepts for optimal study execution. This position may directly or indirectly (matrix) manage professional employees, business support, or technical staff. Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health? is our Purpose, and it?s no small feat. It takes the imagination and passion of all of us?from design and engineering to the manufacturing and marketing of our billions of MedTech products per year?to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you?ll be supported to learn, grow and become your best self. Become a maker of possible with us. Responsibilities Prepares and/or reviews study-related or crucial study start-up documents as they relate to the assigned human subject research trials (e.g., Clinical Protocols, Informed Consent forms, Investigator Brochures, Monitoring Plan, and other relevant study plans and charters) Serves as a Clinical Project Manager ensuring that the Study Management team meets or exceeds the timelines and deliverables assigned to the study team. Responsible for scheduling and running study team meetings and generation of meeting minutes and other study-related documentation. Oversees/leads study-specific study management resources. Accountable for setting own work direction and completing work tasks assigned by leadership team. Develops and handles group of studies for an entire business unit or large development program. Provides critical thinking and leadership when issues arise during execution of clinical studies, including risk management and mitigation actions. Leads or chips in to continuous improvement activities/initiatives. Maintains relationships with sites/PIs and other study related vendors, including CRO?s Intermediate knowledge, of established project management standards used to develop and maintain integrated project plans (scope/work packages, time/schedule, cost/material and human resource, quality, communication/escalation, risk, value) and organizes/facilitates meetings and discussions as needed. Defines, tracks and reports schedule attributes such as durations, interdependencies, milestones, progress, risks, critical path and other key deliverables including efficiency and effectiveness of plans and staff. Adapts work package deliverables based on study scale and complexity. Creates bold but achievable resource and budget forecasts and timelines. Has accountability for good stewardship of financial resources for personal and project expenses. Interacts with both Internal and External contacts, providing direction to the GCA cross functional team members and vendors (if applicable) regarding the technical, protocol-specific and operational aspects of assigned studies. Proactively identifies and handles risks and issues (including a log, mitigations, and contingencies) to ensure cost effective timely delivery of the project, including escalations, as needed. Plans and maintains high quality standards in order to meet compliance requirements. Performs other duties and assignments as required. Professional Skills & Key Competencies Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. This includes analytical problem solving. Consistent record to juggle multiple tasks and to prioritize and schedule work to meet business needs. Validated organizational, planning, and project management skills, including committed, focused urgency, and aiming for result. Ability to be effective in complex projects with ambiguity and/or rapid change. Orientation for detailed work product, with emphasis on accuracy and completeness. Validated understanding of Good Clinical Practice, and all Global, National and Local Regulations. Qualifications Required: Bachelor?s Degree and 3-5 years in human subject research or equivalent Preferred: Advanced degree (MS, MBA, etc.). Highly preferred: Experience directly or indirectly (matrix) handling vendors, cross-functional project team members, and has medical process/program management/ownership. This includes project leadership, employee coaching, mentorship, and supervision of support and entry-level professional associates. Preferred: Ability to apply expertise to improve effectiveness and provide clinical and technical guidance to employees on the team. Highly preferred: Knowledge of and experience using and interpreting basic biomedical statistical methods. Required: Conduct literature searches/reviews, design studies per scientific methods, and complete basic statistical analyses on results. Highly preferred: Experience participating in and/or handling investigational drug or medical device studies, including conducting literature reviews, study design and execution, and compliance monitoring. Required: Experience in continuous process improvement projects and project management. Preferred: PMP certification Highly preferred: Prior clinical practice experience with BD product categories. Preferred: Prior people management, ideally in a matrix environment. Preferred: Prior experience with medical product development. Highly preferred: Confirmed excellent verbal and written communication skills, including the ability to write scientific papers and present at professional conferences. Highly preferred: Work experience with multi-disciplinary/cross-functional teams. Highly preferred: Comfortable working in a position that requires flexibility within a fast paced, multi-task matrixed environment. Additional Requirements Travel may range from 15-30%, overnight travel, including US and international. Position requires flexible working hours, including some nights and weekends, as needed for the support of customer and business activities. For certain roles at BD, employment is contingent upon the Company?s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD?s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It?s also a place where we help each other be great, we do what?s right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you?ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit?https://bd.com/careers Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. PDN Primary Work Location USA CA - San Diego Bldg A&B Additional Locations Work Shift A BD ? uma empresa global l?der em tecnologia m?dica que desenvolve tecnologia, dispositivos e equipamentos laboratoriais m?dicos para atender a v?rias necessidades no setor de atendimento ? sa?de. Na BD, procuramos candidatos com paix?o por solu??es inovadoras e comprometimento com nossa miss?o de aumentar o acesso a servi?os revolucion?rios em medicina e biotecnologia para pessoas no mundo inteiro, oferecendo tecnologia de ponta e pesquisa avan?ada na batalha para combater e curar doen?as infecciosas. Com um alcance global que se espalha por 50 pa?ses no mundo inteiro, nossa rede de profissionais colabora em medidas efetivas para proporcionar maior qualidade para os pacientes, como custos de tratamento menores, maior seguran?a e atendimento aprimorado e com maior alcance para todos. Venha para nossa empresa e veja como voc? poder? se tornar parte de uma miss?o global de fazer a diferen?a na sa?de da humanidade

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