The World Leader In Serving Science
Study Manager, Global Study Management
Location
Mexico
Posted
35 days ago
Salary
0
Seniority
Lead
Job Description
Study Manager, Global Study Management
Thermo Fisher Scientific
Title: Study Manager, Global Study Management - FPS Location: Remote Mexico Full time Remote Join Us as a Study Manager - Make an Impact at the Forefront of Innovation Role Purpose: - Study Manager (SM) is a key member of the Global Study Team contributing to delivering the clinical study to time, cost and quality, and ensuring inspection readiness by taking an oversight over study eTMF completeness. - SM role was implemented to have a broader impact on the business, by driving continuous improvement initiatives within their remit of expertise, sharing best practices across business, with a focus on increasing operational delivery efficiency. Key Responsibilities: - SM works in close partnership with the Study Delivery Lead (SDL) on end-to-end operational study delivery activities, from study setup to study archival, with the focus on setting up, maintaining and ensuring completeness of internal systems / databases / tracking tools and project plans (CSAP). - SM works cross-functionally, with internal and external partners, on clinical study management activities as agreed with the Study Delivery Lead, for in-house and outsourced studies across all phases and therapeutic areas, in accordance with Study Team Operating Model (STOM), current clinical study regulations and sponsor procedures, policies, best practices and standards, and plays a key role in successful study delivery, providing subject matter expertise across key processes and systems throughout the life cycle of the study. - SM is responsible for monitoring study conduct and progress, identifying, resolving and escalating risks/issues which may impact delivery of the study to the necessary quality, timeline and budget objectives. - SM is responsible for reviewing key clinical documents, including the Protocol and Informed Consent Forms, and leading development of study plans (e.g. Monitoring Plan, Vendor Management Plan, Protocol Deviation Management Plan, Risk Management Plan, Communication Plan etc.) for external and internal use in assigned studies. - SM is responsible for facilitating and maintaining interactions and meetings with internal (including but not limited to regulatory, LOC, quality assurance, Monitors meeting) and external partners (including CROs and third-party vendors) to ensure the successful delivery of assigned studies. - SM is responsible for vendor management and CRO oversight, acting as a primary point of contact, overseeing study-specific deliverables, ensuring continued monitoring and timely delivery of activities delegated to third parties. - SM is responsible for country oversight, acting as a primary point of contact, tracking of recruitment progress, data completeness and compliance, overseeing protocol deviations, risks, regulatory approvals and import license status. - SM is responsible for coordinating study-related activities and managing study team’s communication – meetings (preparation, scheduling, meeting minutes), info-spaces, newsletters, action logs, communication plans, team lists. - SM is responsible for overseeing delivery of clinical supplies, investigational products and all study materials provided by sponsor or external service providers and communicating issues/risks to continuity of supplies and proposing solutions as appropriate. - SM is responsible for data oversight to ensure the study is inspection ready at all times, including oversight of eTMF completeness (eTMF setup, periodic reviews, following up on missing documents, Safety Reports Dissemination), and assure that all eTMF documents are complete and verified for quality. - SM is responsible for budget oversight – managing Task / Change Orders, expenses, tracking updates, checking consistency between systems and agreements and escalating issues to the SDL. - SM actively contributes to the squads (potential Scrum Master role in the Global Study Team) and acts as a mediator by breaking down barriers, strengthening team dynamics, building business agility and embracing change. - SM is responsible for performing full set of activities without assistance and has the ability, and the seniority, to support any types of studies and activities which require clinical trial expertise with limited instructions from the SDL. - SM acts as a mentor for less experienced colleagues. Education Requirements (minimum expected): - University degree or equivalent, preferably in medical or biological science or discipline associated with clinical studies Role Related Experience (minimum requirements): - At least 3+ years of relevant work experience in a pharmaceutical/scientific environment. - Knowledge of clinical trials, drug development process. - Excellent knowledge of ICH-GCP, clinical study delivery process, including regulations, operational best practices, industry standards. Well familiar with key systems used in clinical trial delivery. Experience in using Trial Master File industry accepted standard. - Strong project management skills (preferably with analytical / financial skills) and good leadership skills. - Excellent verbal and written communication in English. - Excellent communication and relationship building skills, including external service provider management skills. Other Role-Related Skills: - Excellent knowledge of, and skills in applying, applicable clinical trial regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines. - Ability to manage multiple competing priorities within various clinical studies with good planning, time management and prioritization skills. - Ability to think independently, analyse and solve problems systematically and creatively, and to take a risk-based approach. - A confirmed level of expertise and seniority within the area and function. - Logical / analytical thinking and an inclination to spot patterns and outliers. Quality mindset, critical sense, attention to details, effective training and mentoring skills. - Very good understanding of the principles of project planning and management. - Knowledge of project finance and accounting principles in order to understand budget, invoices, cross-charges and expense reports. - Excellent comprehension of Microsoft Office tools (Excel, PowerPoint, Word, Outlook, etc.). Knowledge of advanced Excel, timelines/budget tracking systems and clinical trial management systems. - Excellent stakeholder management and communication skills (oral and written), outstanding interpersonal skills. - Excellent networking capabilities and ability to influence and manage stakeholders at all levels of the organization, ability to facilitate and lead cross-functional meetings, challenge status quo and inefficient ways of working and be comfortable in a mediator role. - Results driven and efficient. Motivated and dynamic personality. Able to evolve in a changing and challenging environment, coach the study team members to focus on value, building business agility and embracing change. - Ability to adjust to work in cross-functional squads in the agile model. - Team spirit and ability to work across cultures and geographies with a high awareness and understanding of cultural differences.
Related Guides
Related Categories
Related Job Pages
More Manager Jobs
Traffic Manager
Relou Rh EspecializadoEmpresa em crescimento, com cultura voltada para alta performance, relacionamento estratégico e desenvolvimento contínuo. O ambiente valoriza pessoas com mentalidade de crescimento, senso de dono e vontade de construir carreira no comercial. A operação acredita que vendas são consequência de processo, posicionamento e conexão genuína com o cliente — e busca profissionais que entendam o impacto de uma boa negociação.
Role Description Estamos buscando um(a) Gestor(a) de Tráfego que enxergue mídia paga como sistema, não como campanha isolada. Aqui, o tráfego não vive sozinho: ele conversa com funil, dados, automação, vendas e tomada de decisão. Se você gosta de processo bem feito, números claros, responsabilidade real e impacto direto no crescimento de empresas da economia real, essa vaga é pra você. Responsibilities - Criar, gerenciar e otimizar campanhas de tráfego pago - Monitorar métricas e indicadores de performance - Desenvolver estratégias de aquisição e conversão - Analisar dados e identificar oportunidades de melhoria - Elaborar relatórios e apresentações de resultados - Realizar testes e otimizações contínuas nas campanhas - Acompanhar tendências, atualizações e mudanças das plataformas - Apoiar no crescimento das contas e performance dos clientes Qualifications - Cases reais e domínio técnico do processo de geração de leads - Visão analítica sobre funil, métricas e impacto no negócio - Domínio de: Google Ads, Meta Ads, Google Tag Manager, Planilhas - Ferramentas de gestão de tarefas - Familiaridade com automações e ferramentas de análise - Vivência em agências ou operações de performance - Comunicação clara, objetiva e respeitosa Company Description Empresa em crescimento no mercado digital, focada em gerar resultados reais através de estratégias inteligentes de marketing e performance. A cultura valoriza pessoas comprometidas, curiosas e com mentalidade de crescimento, que entendam a importância de unir execução rápida com pensamento estratégico. O ambiente é colaborativo, acelerado e aberto para profissionais que queiram construir carreira no digital.
Senior Manager, Member Services
Wider CircleWe work with health plans to connect vulnerable populations for better health through in-person and virtual programming.
• Own day-to-day outreach center performance: inbound and outbound call handling, campaign execution, scheduling, workforce management, and real-time quality monitoring. • Manage and optimize calling campaigns in Five9 or a comparable platform, including call routing, queue management, and agent productivity. • Analyze contact center KPIs to identify trends, address performance gaps, and continuously improve member engagement outcomes. • Build and maintain a QA framework that ensures consistent call quality, HIPAA compliance, and audit-ready documentation. • Drive measurable outcomes against value-based care goals: care gap closures, Annual Wellness Visits, Health Risk Assessments, HEDIS measures, Patient Reported Assessments, and SDOH initiatives. • Monitor the impact of quality and risk adjustment activities; develop corrective action plans when performance trends indicate risk. • Track and report KPIs across outreach effectiveness, care gap completion, and value creation; present results to senior leadership. • Lead Team Leads as direct reports, setting performance expectations, providing coaching, and holding the supervisory tier accountable for frontline outcomes. • Manage staffing models, scheduling, and workload distribution across the team. • Develop and deliver training that builds frontline capability and keeps the team equipped to meet evolving program requirements. • Establish a performance culture with clear goals, regular evaluations, and visible career progression for frontline staff. • Partner with Technology, Product, Data, and Finance to improve dashboards, automation, and reporting capabilities. • Collaborate across departments to support new client requirements and align Member Services with broader organizational goals.
Manager, Certifications
HighLevelThe all-in-one sales & marketing platform that agencies can white-label. CRM, Email, 2-way SMS, Funnel Builder, & more!
• Direct, mentor, and scale a remote team of Certification Specialists, managing daily shift schedules, proctoring assignments, and grading audits. • Build and continuously improve scalable systems, workflows, and quality controls that enable the certification program to operate as a high-impact business function. • Identify opportunities to improve certification adoption, candidate success, operational scalability, and community engagement across the broader HighLevel ecosystem. • Oversee the end-to-end certification pipeline, ensuring optimal exam slot booking availability and timely processing of exam results. • Enforce and continuously audit testing security protocols to maintain the absolute integrity of both the automated and live proctored certification exams. • Partner with Product, Customer Success, and the Academy teams to regularly update curriculum, test questions (Part A), and live-build scenarios (Part B) to reflect new platform updates. • Resolve candidate complaints, appeal requests, and technical issues occurring during the proctoring process with consistency and fairness. • Own the operational success and long-term scalability of the certification program, developing strategic plans, processes, and capacity models to support future growth. • Manage the integration of newly certified professionals into the HighLevel Certified Directory and Certified Communities. • Conduct regular quality assurance checks on live proctored sessions to ensure Certification Specialists maintain professional, supportive, and unbiased grading standards. • Other duties as assigned by the Director of Certifications to support evolving business and program needs.
Role Description Regional field service management responsibility which includes but not limited to: - Alignment with regional sales managers to provide localized service support - Customer site visits - Defusing tense situations - Application evaluations - Contracted service provider relationships and recruitment - On the job training for contracted service providers - Start-up and commissioning of product - Field conversions - Quality and engineering liaison regarding product issues - Manufacturing and product engineering field support - New product development and reliability projects This position requires up to 80% travel to support assigned territory. Responsibilities - Travel 80% to support and maintain assigned region (States include - NM, AZ, CA, CO, ID, UT, NV, WY, MT, WA and OR) - Aligned with Regional Sales managers to provide localized service support - Direct investigation of customer complaints regarding quality, tolerances, specifications, and delivered condition of products - Maintain customer relationships during customer investigations - Recruit, train and sustain contracted service providers for adequate service coverage in the market - Work closely with National Service Department to develop and maintain the service provider network - Access training needs, skill levels and identify training opportunities for service providers - Maintain relationships with Reps and provide clear guidance on company policies, processes, and procedures - Negotiate validated labor claims with Reps & non-CSP’s - Communicate with manufacturing, quality assurance, sales, and engineering to resolve customer complaint issues - Record, analyze, and inform concerned associates of production quality assurance, and sales departments of status and disposition of customer complaints and claims - Utilize interpersonal skills to communicate professionally at all levels within the operational customer/supplier environment Additional Responsibilities - Provide written technical engineering reports of projects that incorporate the complete understanding of an integrated Water Heating System - Provide technical and service assistance to Company customers via telephone contact - Perform field service on all Company products as required - Assist in preparation of Technical Service Bulletins to provide product related information to the field - Mentor and develop new Field Service Engineers/technicians - Provide site inspection, start-up and conversion coordinator back up as needed - Utilize statistical tools and techniques to analyze product and component field failures and warranty data to report recommendations - Provide VOC data and work with our product engineering department for reliability testing and new product testing - Participate with reliability engineering to identify test sites, assist in monitoring and reporting test data for the projects - Actively participate in corrective and preventative action teams across the business - Serve as a liaison with customers to assure prompt responsive action to any quality issue as necessary - Develop, sustain, and continuously improve field service engineering processes to assure the quality of service to the customer - Assist Legal Dept and Risk management on claims and site evaluations - Assist other departments as needed - Perform any other activities as needed or as directed Qualifications - Bachelor's Degree in related field. Will consider those with an associate degree in technical related field and equivalent experience - 5+ years related work experience - 5+ years HVAC/Plumbing/Mechanical related experience - Trade Certification, such as Certified Quality Engineer, EPA608, NATE preferred - Proficiency with computers and programs, specifically Microsoft Office software, SalesForce, SAP - Proficient customer service experience - Demonstrated experience in Electrical or Mechanical aptitudes, and HVAC systems - Demonstrated experience in Control Systems (PLCs) and Building Integration Systems preferred - Possess a general understanding of local, state, and national codes/regulations - Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists - Ability to work independently and as a team to meet deadlines and goals - Demonstrated comprehension of electrical systems, low voltage, high voltage, single and three phase systems - Demonstrated comprehension of gas supply systems (Natural/Propane) and regulation - Demonstrated comprehension of #2 fuel oil and delivery systems - Demonstrated comprehension of water supply systems, pressure boosting systems, regulation, piping scenarios, etc. - Demonstrated comprehension of HVAC and refrigeration systems Benefits - Competitive base salary - Comprehensive benefits plans which include medical and dental insurance - Company-sponsored life insurance - Retirement security savings plan - Short- and long-term disability programs - Tuition assistance
