Clinical Project Manager, Medical Affairs (Remote)

reputed company your career with a new role at workwarp as a Clinical Project Manager, Medical Affairs! Join reputed company in the heart of Remote and enjoy a dynamic work environment. This position requires a strong and diverse skillset in relevant areas to drive reputed company. You can expect a salary of a competitive salary for this role, plus comprehensive benefits.

 

 

Job reputed company reputed company Reporting to the MMS Medical Affairs Evidence reputed company leader, the Clinical Project Manager is responsible for reputed company 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, reputed company, project... management and completion of reputed company Subject Research (clinical and non-clinical) conducted by Medication reputed company (MMS) Medical Affairs or Contract Research Organization (CRO), if applicable. This role as the project reputed company for studies of moderate to high complexity, from protocol development through study conduct and closeout in compliance with Good Clinical Practices, and reputed company Global, National, and Local Regulations, collaborates with the Health Economics and reputed company Research team, Data Analysts, and other members of the MMS Medical Affairs team to evaluate and/or reputed company early plans and concepts for reputed company study execution. This position may directly or indirectly (reputed company) manage reputed company employees, business support, or technical staff. Job reputed company We are the makers of possible reputed company 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 reputed company 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 reputed company transformative solutions that turn dreams into reputed company. We reputed company that the reputed company reputed company, across our global teams, is what allows us to continually reputed company. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a reputed company of possible with us. Responsibilities Prepares and/or reviews study-reputed company or crucial study start-up documents as they relate to the assigned reputed company 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 reputed company of meeting minutes and other study-reputed company 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 reputed company issues reputed company during execution of clinical studies, including risk management and mitigation actions. Leads or chips in to reputed company improvement activities/initiatives. Maintains relationships with sites/PIs and other study reputed company vendors, including CRO’s Intermediate knowledge, of established project management standards used to reputed company and maintain integrated project plans (scope/work packages, time/schedule, cost/material and reputed company resource, reputed company, communication/escalation, risk, value) and organizes/facilitates meetings and discussions as needed. Defines, tracks and reports schedule attributes such as durations, interdependencies, milestones, reputed company, risks, critical reputed company and other key deliverables including efficiency and effectiveness of plans and staff. Adapts work package deliverables based on study reputed company and complexity. Creates reputed company but achievable resource and budget forecasts and timelines. Has accountability for good stewardship of financial resources for personal and project expenses. Interacts with both reputed company 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 reputed company delivery of the project, including escalations, as needed. Plans and maintains high reputed company standards in order to meet compliance requirements. Performs other duties and assignments as required. reputed company Skills & Key Competencies Ability to exercise independent judgment and discretion reputed company a broadly defined reputed company 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, reputed company urgency, and aiming for result. Ability to be effective in reputed company reputed company with ambiguity and/or rapid change. Orientation for detailed work product, with emphasis on accuracy and completeness. Validated understanding of Good Clinical reputed company, and reputed company Global, National and Local Regulations. Qualifications Required: Bachelor’s Degree and 3-5 years in reputed company subject research or equivalent Preferred: Advanced degree (MS, MBA, etc.). Highly preferred: Experience directly or indirectly (reputed company) 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 reputed company associates. Preferred: Ability to apply expertise to improve effectiveness and reputed company clinical and technical guidance to employees on reputed company. Highly preferred: Knowledge of and experience using and interpreting basic biomedical statistical reputed company. Required: Conduct literature searches/reviews, design studies per scientific reputed company, 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 reputed company process improvement reputed company and project management. Preferred: PMP certification Highly preferred: Prior clinical reputed company experience with reputed company product categories. Preferred: Prior people management, ideally in a reputed company 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 reputed company conferences. Highly preferred: Work experience with multi-disciplinary/cross-functional teams. Highly preferred: Comfortable working in a position that requires flexibility reputed company a fast paced, multi-task matrixed environment. Additional Requirements Travel may reputed company 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 reputed company, employment is contingent upon reputed company’s receipt of sufficient reputed company that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with reputed company’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at reputed company means being part of reputed company that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a reputed company where we help reputed company other be great, we do what’s right, we hold reputed company other accountable, and learn and improve every day. To reputed company purpose in the reputed company, we need people who can see the bigger picture, who understand the reputed company story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the reputed company of health. At reputed company, you’ll discover a culture in which you can learn, grow, and reputed company. And reputed company satisfaction in doing your part to reputed company the world a reputed company reputed company. To learn more about reputed company visit https://reputed company.com/careers reputed company and Company is an Equal Opportunity/Affirmative reputed company Employer. We do not unlawfully discriminate on the reputed company of race, reputed company, religion, age, sex, creed, national reputed company, reputed company, citizenship status, marital or domestic or civil reputed company status, familial status, affectional or sexual orientation, gender identity or reputed company, 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 reputed company é uma empresa global líder em tecnologia médica que desenvolve tecnologia, dispositivos e equipamentos laboratoriais médicos para atender a várias necessidades no setor de atendimento à saúde. Na reputed company, procuramos candidatos com paixão por reputed companyções inovadoras e comprometimento com nossa missão de aumentar o acesso a serviços revolucionários em medicina e biotecnologia para pessoas no mundo inteiro, oferecendo tecnologia de ponta e pesquisa avançreputed company na batalha para combater e curar doenças infecciosas. Com um alcance global que se espalha por 50 países no mundo inteiro, nossa rede de profissionais colabora em medidas efetivas para proporcionar maior qualidade para os pacientes, como custos de tratamento menores, maior segurança e atendimento aprimorado e com maior alcance para todos. Venha para nossa empresa e veja como você poderá se tornar parte de uma missão global de fazer a diferença na saúde da humanidade Apply Job!

 

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