Role Description The Sr CRA II / Site Management - FSP model is responsible for the following: - Performs site qualification, site initiation, interim monitoring, site management, and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance. - Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. - Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. - Demonstrates diligence in protecting the confidentiality of each subject/patient. - Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes, conducts Source Document Review of appropriate site source documents and medical records, verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records. - Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. - Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. - Verifies site compliance with electronic data capture requirements. - May perform investigational product (IP) inventory, reconciliation and reviews storage and security. - Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. - Verifies issues or risks associated with blinded or randomized information related to IP. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. - Reconciles contents of the ISF with the Trial Master File (TMF). - Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. - Supports subject/patient recruitment, retention and awareness strategies. - Enters data into tracking systems as required to track all observations, ongoing status and action items to resolution. - Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities/communication to ensure project objectives, deliverables and timelines are met. - May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. - Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements. - Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. - Participates in and may lead global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - May provide direct supervision, training and/or mentorship to more junior level CRAs. - Performs training and sign off visits for junior CRA staff, as assigned. - May be mentored and assigned lead tasks under supervision of an experienced Clinical Operations Lead (COL) or operational line manager. - For Real World Late Phase (RWLP), the Sr. CRA II will use the business card title of Sr. Site Management Associate II. - Additional responsibilities include site support throughout the study lifecycle from site identification through close-out. - Knowledge of local requirements for real world late phase study designs. - Chart abstraction activities and data collection. - As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country staff. - The SMA II may be requested to train junior staff. - Identify and communicate out of scope activities to Lead CRA/Project Manager. - Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. - Identify operational efficiencies and process improvements. - Develop study and country level informed consent forms. - Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared. - Participate in bid defense meetings. - Provide input into Requests for Proposals (RFPs), scope and budgeting. - Develop site management strategy. - Participate in Case Report Form design and edit check development. Qualifications - Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience. - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. - Must demonstrate good computer skills and be able to embrace new technologies. - Excellent communication, presentation and interpersonal skills. - Moderate level of critical thinking skills expected. - Ability to manage required travel of up to 75% on a regular basis. Benefits - Passionate about developing our people through career development and progression. - Supportive and engaged line management. - Technical and therapeutic area training. - Peer recognition and total rewards program. - Commitment to building an inclusive culture. - Opportunity to shape solutions that have the ability to dramatically impact someone’s life. - Collaboration with smart colleagues from across the world.

• Define and architect the deployment, automation, and management of cloud applications portfolio and infrastructure. • Lead a global team of fifteen DevOps engineers distributed over different geographies towards the success of various initiatives. • Develop and implement DevOps and DevSecOps strategies, aligning with company's goals and objectives. • Establish and maintain best practices for infrastructure automation, continuous integration and deployment (CI/CD), monitoring, and release management. • Drive automation initiatives to streamline operational tasks, including infrastructure provisioning, release notes, configuration management, and deployment processes. • Implement and ensure DevOps metrics are met. • Organize verbal and written ideas clearly and use an appropriate business style.

• Implementarea și gestionarea infrastructurii cloud folosind Azure sau alte servicii și instrumente ale furnizorilor de cloud • Dezvoltarea și implementarea soluțiilor de automatizare pentru configurarea și gestionarea resurselor cloud • Crearea și gestionarea pârtiilor de livrare continuă și a desfășurării automate folosind Azure DevOps sau platforme similare • Monitorizarea și rezolvarea problemelor de performanță a sistemelor și aplicațiilor pentru a asigura stabilitatea și disponibilitatea • Documentarea și comunicarea arhitecturii, proceselor și procedurilor pentru a asigura transparența și reproductibilitatea operațiunilor

WeWork Reforma Latino (97001), Mexico, Ciudad de Mexico, Ciudad de Mexico Senior Market Manager - Workplace Ops At Capital One, we dare to dream, disrupt and deliver a better way. Our goal is simple-bring ingenuity, simplicity and humanity to an industry ripe for change. Our Global Workplace Services (GWS) team is a dynamic organization wheredevelopment matters as much as our ability to provide collaborative and secure environments that drive connection, innovation and business success. Our commitment extends beyond solutions; it embraces a culture of care. We value, celebrate and respect each teammate's unique talents, experience, and contributions. In GWS, our team manages a diverse portfolio of mixed-use owned and leased properties. We're constantly transforming our workplace to enable our employees to work the way they work best. But it doesn't stop there. We don't just reimagine and create fabulous spaces and amenities, we also manage and operate them and ensure the safety and security of our employees and the community-we're a well-oiled machine! That's why our team is looking to add a Senior Market Manager in Workplace Operations. As a Senior Market Manager in Workplace Ops, you'll manage the day-to-day relationships with our internal customers and lines of business, and engage with external providers responsible for facilities, space planning, moves, food and beverage services and mail services. You will also help partner on the execution of security strategies that will improve operational effectiveness and ensure the safety of Capital One employees and customers within the community. The ideal candidate should: - Lead teams and across levels through strategic and compelling storytelling that drives action/outcomes - Prioritize the customer experience by getting first hand customer information and considering perspectives to solve immediate needs - Guide, motivate and inspire others to think differently and deliver results through fact-based recommendations and building consensus - Quickly establish themselves as a subject matter expert and offer their skills to assist others - Incorporate prior experience, data, the expertise of others, requirements and good judgment when making decisions - Model and promote values, shape team culture and celebrate value-driven behavior - Understand when to change processes in order to innovate and collaborate to ensure solution feasibility - Drive results by making adjustments to overcome obstacles, holding others accountable, setting milestones and ensuring efforts are aligned to business priorities - Remove obstacles for team, bring visibility to team impact, and build a spirit of camaraderie - Set team tone and culture, prioritizing empowerment and psychological safety; and consider expertise from broader team to delegate and create leverage Key Responsibilities: Operational Excellence - Lead third-party providers responsible for facilities, space planning, moves, food and beverage services, hospitality, conferencing, AV and print/mail services - Measure and report on vendor performance according to service provider scope of work and KPIs - Own and drive solutions that optimize facility utilization - Promote operational excellence in customer service and a seamless user experience across providers - Enable service providers to innovate and deliver transformational results - Maintain landlord relationships and engage with landlords facilities team as required Strategy & Relationship Management - Partner with internal Capital One stakeholders such as Finance, HR, Risk, Legal, IT, Supplier Management and other lines of business - Serve as the trusted real estate expert and partner for cross-functional teams at all levels, internally and externally - Deliver high-performing results while balancing customer needs and communicating Global Workplace Services strategies and best practices - Foster a positive work environment through engagement and team building activities Project Oversight - Contribute to the development of the annual CapEx and Opex budgets - Partner with other GWS teams to create solutions and/or solve problems in a proactive manner - Recommend opportunities for cost savings but more importantly, efficiency improvements that increase employee productivity Risk Mitigation - Mitigate risks by partnering closely with real estate service provider and internal Capital One Risk teams, as to ensure we are well managed at all times - Manage safety and security issues stemming from incident reports - Partner with business continuity teams to ensure all facilities are prepared before and after an emergency situation Basic Qualifications: - Bachelor's Degree - At least 10 years of experience in Facilities Management or Relationship Management - At least 5 years of experience managing facilities for multiple locations Preferred Qualifications: - At least 6 years of experience in Project Management, People Management or Supplier Management - At least 5 years of experience in Workplace Strategy or Strategic Real Estate Planning - At least 5 years of experience with G Suite tools At Capital One, we respect individual differences in culture, religion, and ethnicity. Likewise, we promote equal opportunities and development for all personnel. In the hiring process, we seek to provide equal employment opportunities to candidates, regardless of race, color, religion, gender, sexual orientation, marital or civil status, national origin, disability, or any other situation protected by federal, state, or local laws. For technical support or questions about Capital One's recruiting process, please send an email to Careers@capitalone.com Capital One does not provide, endorse nor guarantee and is not liable for third-party products, services, educational tools or other information available through this site. Capital One Financial is made up of several different entities. Please note that any position posted in Canada is for Capital One Canada, any position posted in the United Kingdom is for Capital One Europe, any position posted in the Philippines is for Capital One Service Corp (COPSSC), and any position posted in Mexico is for Capital One Technology Labs Mexico.