Central Monitoring Manager

Encontrado en: Talent MX C2 - hace 3 semanas

Mexico City Fortrea A tiempo completo

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Job Summary

The Central Monitoring Manager has a critical role in ensuring full implementation of the risk plan and recommending appropriate changes to the ongoing monitoring. The Central Monitoring Manager collaborates within a matrix environment, communicates proactively internally and externally and across functions with key stake holders to ensure plans are proactively and effectively executed to meet client expectations The Central Monitoring Manager is expected to have a substantial working and industry knowledge of drug development and clinical trial execution. He/she is responsible for the preparation and conduct of central monitoring (Site, subject & study level review as applicable) activities on a series of sponsor projects or sponsor portfolio from proposal to study report. He/she conducts the central monitoring activities and recommends mitigations to project teams and oversees the findings at site, subject and study level.He/she provides the necessary support to the study team

Essencial Job Duties

Performs the Central monitoring activities for multiple studies and ensure accurate tracking and status reporting of studies in his/her remit.

Manage portfolio of studies for a Customer and act as a customer point of contact

Collaborates in the development Central Monitoring proposal text and review of costing, contributes to proposal strategy and development.

Collaborates in the development of sponsor presentations/bid defense support.

Oversees at a study/customer level the appropriate tracking, interpretation and application of data to proactively manage risk

Ensures that tracking and status reporting are performed in a timely and accurate manner.

Applies data to recommend any required changes

Leads, plans, prepares, conducts and follows up the central monitoring (Site, subject & study level review as applicable) activities and supports less experienced team members

Supports PMO in preparation of initial Risk Management Register and may prepare, distribute and follow up Study Risk Impact Reports and coordinate Site Risk Weighting.

Ensures Critical Data & Process Definition are implemented in EDC design by Data Expert

Conducts Site Risk Assessment across multiple studies, works with study start up team members, reviews site outreach, Pre-Study Visit reports and Site Risk Assessment. Prepares site risk stratifications and proposes baseline site risk levels and initial site monitoring intervention levels

Develops and establishes requirements including prescriptive risk factor mitigation strategies, SDV strategy, study-specific risk factor definition, variable Risk Factor trigger levels.

Develop the Central Monitoring and other applicable plans and any subsequent changes.

Manages configuration of tools, risk factors trigger levels, programming of study specific risk factors and central monitoring parameters and performs user acceptance testing of applicable tools

Performs ongoing dashboard reviews, prepares and recommends mitigation actions and

reviews recommended monitoring levels with project team and ensures that identified issues are followed to resolution 

Agrees potential changes to monitoring intervention level with project team in line with the applicable plans, and escalates appropriately.

Performs subject clinical reviews and take appropriate actions as applicable

Performs study analytics reviews as per the applicable plans and communicate the findings appropriately

Reviews and Approves changes to monitoring levels, ensuring compliance with applicable

Plans and sponsor needs are met.

Oversees Project Quality and Risk Reports to ensure client satisfaction and compliance.

Coaches assigned project teams internally and externally to increase the central monitoring competence.

Contributes to the development and maintenance of processes, including SOP writing, process mapping and process improvements using Six Sigma and LEAN methodologies.

Evaluates and collates process improvement suggestions and submits to leadership.

Evaluates and submits ideas and justification for improved systems and tools to leadership.

Any other duties assigned by supervisor

Main requirements

University / college degree or post-graduation (life science preferred) from an appropriately accredited institution.

Minimum of 7-9 years of relevant clinical research experience in a pharmaceutical company/CRO or other equivalent experience with increasing levels of responsibility in clinical trial related roles e.g. project management, clinical monitoring, data management and informatics.

Fluent English

End to End RBQM experience is preferred

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

  • Associate Centralized Monitoring Lead

    Encontrado en: Talent MX C2 - hace 3 semanas

    Mexico City IQVIA A tiempo completo

    Job Overview Leader of the Centralized Monitoring team, partner with the project and clinical lead to achieve the delivery of the project’s overall objectives to the sponsor’s satisfaction per contract, while optimizing speed, quality and cost of delivery and in accordance with IQVIA SOPs, policies and practices. Essential Functions: Leadership...

  • Partner Sales Manager

    Encontrado en: Talent MX C2 - hace 3 semanas

    Mexico City Datadog A tiempo completo

    Partner Sales Manager Mexico City, Mexico Our Channels & Alliances Team’s charter builds and activates a strategic, differentiated and high-impact partner ecosystem for our best-of-breed multi-cloud monitoring product, one partner at a time. As a Partner Sales Manager, you will build channels and alliances that drive new customer adoption and...

  • Brand Manager Derma

    Encontrado en: Talent MX C2 - hace 3 semanas

    Mexico City Lilly A tiempo completo

    We’re looking for people who are determined to make life better for people around the world. Manager - Dermatology Portfolio Responsibilities: As the Dermatology Brand Manager you will play a critical role in achieving the successful launch of 2 important indications in the near future and building/strengthening Eli Lilly presence with the...

  • Country Manager

    Encontrado en: Talent MX C2 - hace 3 semanas

    Mexico City BESTSELLER A tiempo completo

    Estamos buscando un profesional altamente calificado con experiencia en el sector de Retail Moda Internacional. Como Country Manager, tendrás la responsabilidad de liderar el desarrollo de nuestras operaciones comerciales de Wholesale, Retail y E-commerce en la región, trabajando en estrecha colaboración con oficina central para alcanzar los objetivos...

  • Business intelligence sales performance manager

    Encontrado en: Talent MX C2 - hace 6 días

    Mexico City Believe A tiempo completo

    Job DescriptionWithin the Operations, the aim of the regional Go To Market (GTM) Manager is to ensure all sales functions work efficiently by delivering best-in-class, efficient, timely and reliable local go to market strategies and sales Enablement. Thanks to a perfect understanding of our products, offers, value chain and processes, you will be able...

  • Credit Risk Policy Manager

    Encontrado en: Talent MX C2 - hace 4 días

    Mexico City Citi A tiempo completo

    El Gerente de Riesgo Comercial brinda un liderazgo completo y tiene la responsabilidad de supervisión. Proporciona dirección y liderazgo operativo/de servicios a los equipos. Aplica conocimientos disciplinarios mediante la provisión de perspectivas de valor agregado o servicios de asesoría. Puede contribuir con el desarrollo de nuevas técnicas, modelos...

  • Delivery Manager WPS

    Encontrado en: Talent MX C2 - hace 2 semanas

    Mexico City Nouryon A tiempo completo

    Global Delivery Manager Workplace Services Mexico City  At Nouryon, our global team of Changemakers takes positive action every day, to reach higher collectively and individually. We create innovative and sustainable solutions for our customers to answer society’s needs – today and in the future. The Delivery Manager WPS is responsible...

  • Business intelligence sales performance manager

    Encontrado en: Talent MX C2 - hace 6 días

    Mexico City Believe A tiempo completo

    The Job Within the Operations, the aim of the regional Go To Market (GTM) Manager is to ensure all sales functions work efficiently by delivering best-in-class, efficient, timely and reliable local go to market strategies and sales Enablement.  Thanks to a perfect understanding of our products, offers, value chain and processes, you will be able...

  • Community Manager

    Encontrado en: Talent MX C2 - hace 3 semanas

    Mexico City Sagan A tiempo completo

    Position Title: Community ManagerLocation: Remote (EST Timezone)Working Schedule: Monday - Friday, 10:00 AM to 06:00 PM (EST)Position Summary: We are seeking a dynamic and experienced Community Manager, an exclusive community for property managers. The Community Manager will play a pivotal role in nurturing and growing our online platform, fostering member...

  • Program Manager, LATAM First Mile, ECCF Central Team

    Encontrado en: Talent MX C2 - hace 3 semanas

    Mexico City Servicios Comerciales Amazon Mexico S. de R.L. de C.V. - D44 A tiempo completo

    We are looking for a talented Program Manager who will create solutions to optimize our First Mile operations across Amazon's Transportation network. Our team's scope includes all emerging countries, and this role will be focused on the LATAM region (Mexico and Brazil). At Amazon we are building a world class first and last mile operation. As a team player,...

  • Sr Contract Manager, Engineering Projects

    Encontrado en: Talent MX C2 - hace 3 semanas

    Mexico City Siemens, S.A. de C.V. A tiempo completo

    Somos Siemens. ¡Una equipo de más de 5,000 mentes fenomenales que están formandoel futuro y tú puedes ser parte de ello! Tenemos fábricas en todo México,llenas de personas trabajadoras que nos ayudan a desafiar el hoy y trabajarhacia un mañana más brillante. Si todos pensáramos lo mismo, ¡nunca pensaríamosen nada nuevo! Es por eso por lo que...

  • Service Level Manager

    Encontrado en: Talent MX C2 - hace 3 semanas

    Mexico City Zebra A tiempo completo

    Remote Work: Yes Overview: At Zebra, we extend the edge of possibility by shaping the future of work on the front line—reinventing how businesses run and moving society forward. We are a community of changemakers, innovators and doers who come together to deliver a performance edge to the front line of business. We develop new technologies...

  • Senator OTC Team lead

    Encontrado en: Talent MX C2 - hace 3 semanas

    Mexico City Maersk A tiempo completo

    Has responsibility for daily people leadership in smaller sub teams, focusing on specific sub processes or geographies. Provides input to and manages the daily activities under the supervision and guidance of the manager. Is often a senior with specific insight to the process, which enables coaching of team members. Participates in transactional work as...

  • Test Manager

    Encontrado en: Talent MX C2 - hace 3 semanas

    Mexico City Capgemini A tiempo completo

    RH: David ReyesPosición: Test Lead / ManagerUbicación: Presencial - GuadalajaraIndustria: Banking Tus funciones:Estrategia y planificación de pruebas. Responsable de la coordinación y entrega general del trabajo con los miembros del equipo nearshore/offshore Pruebas de clientes potenciales para las iniciativas de transformación y/o carteras de...

  • Regional Manager

    Encontrado en: Talent MX C2 - hace 3 semanas

    Mexico City Royal Enfield A tiempo completo

    Job Requirements Position title Regional Manager - LATAM   Reports to Head - LAD   Job grade Manager   Location Mexico   Job Purpose The role of Regional Manager - LATAM will be part of the International Business team (Americas) within the Global Commercial Organization. The incumbent will be responsible for leading the sales...

  • Social Media Manager

    Encontrado en: Talent MX C2 - hace 3 semanas

    Mexico City Eastman A tiempo completo

    ResponsibilitiesWe are seeking a skilled social media manager with a passion for building our brand presence on social media and leveraging performance-driven metrics to enhance our brand experience. As the social media manager, you will leverage mix of strategic skills and creative thinking with a focus on creating high performing content for our B2B...

  • EF Operations Manager, External Fulfillment

    Encontrado en: Talent MX C2 - hace 3 semanas

    Mexico City Servicios Comerciales Amazon Mexico S. de R.L. de C.V. A tiempo completo

    External Fulfillment (EF) includes a variety of programs in which Amazon works hand in hand with a wide range of Sellers and Vendors to ship product from their warehouse. This role focuses on the enablement and standardization of processes across the operations. It focuses on creating and executing solutions through the automation of tools that will help the...

  • First Line Manager

    Encontrado en: Talent MX C2 - hace 2 semanas

    Mexico City Teva Pharmaceuticals A tiempo completo

    The opportunityIT Services and Support is looking for an experienced First Line Manager (FLM), Global Workplace Support Services to lead the Customer Experience team that supports the IT service desk team providing L1 support consistently across Teva. An ideal candidate will bring a combination of hands-on technical and proficient team management qualities...

  • Community Manager Intern

    Encontrado en: Talent MX C2 - hace 1 semana

    Mexico City Bright A tiempo completo

    ☀️ About Bright:Hey there! We’re Bright, a fintech solar energy startup on a mission to reverse climate change, starting in Mexico. We do so as a finance and technology layer powering the solar installer and entrepreneurial ecosystem - working hard to simplify the process through automation. In just a few years, we've become Mexico's #1 residential...

  • Manager, Content FP&A

    Encontrado en: beBee S MX - hace 3 semanas

    Mexico City WARNERMEDIA A tiempo completo

    Every great story has a new beginning, and yours starts here.Welcome to Warner Bros. Discovery… the stuff dreams are made of.Who We Are… When we say, “the stuff dreams are made of,” we’re not just referring to the world of wizards, dragons and superheroes, or even to the wonders of Planet Earth. Behind WBD’s vast portfolio of...