Clinical Fsp Quality Manager
hace 2 semanas
Job OverviewThis role is an individual contributor assigned to designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by the line manager (LM).The purpose of this role is to work together with operations, global or regional Quality Management team(s), functional teams, customer and other stakeholders in a joint effort to adopt the Quality Plan, Standard Operating Procedures (SOPs), improving compliance to International Council for Harmonization (ICH), Good Clinical Practice (GCP), Key Performance Indicators (KPIs), applicable regulatory requirements, and guidelines.This role provides advice and supports clinical staff and other relevant key stakeholders with regard to **risk identification/management, proactive quality control and corrective/preventive actions upon issues arise.**Essential Functions- Adopt and implement the global Quality Management Plan within the scope of the assignment, this will include: Planning and executing the Quality Management activities. Risk identification and assessment through data review and quality control processes. Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement. Supporting the assigned business line management and staff to enhance effectiveness.;- Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery.- Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management plan and Risk Management Program, monitor the implementation and delivery.- Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance.- Work in close cooperation with teams to manage non-compliance, quality issues, support in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs.); Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.;**Qualifications**- Bachelor's Degree Bachelor's Degree or equivalent qualification.- Quality Management experience within CRO/Pharmaceutical industry- Sound working knowledge of medical terminology, Standard Operating Procedures (SOPs), Council for Harmonisation (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, quality management processes.- Knowledge of National and International Regulations and Drug Development processes.- Knowledge of Clinical Research Organization (CRO) or Pharmaceutical industry operations.- Knowledge of IQVIA corporate standards and SOPs.- Fluent in English.- Ability to travel within the region/country. | Up to 80% travel - domestic/regional travel to Latin America/Potential to North America- Good organizational, interpersonal and communication skills.- Good judgement and decision-making skills.- Strong influencing and negotiation skills.
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Clinical Trial Oversight Manager
hace 1 semana
Ciudad de México Amgen A tiempo completo**Join Amgen’s Mission of Serving Patients**: At Amgen, if you feel like you are part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four...
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Clinical Study Planning Manager/project Manager
hace 2 semanas
Ciudad de México Parexel A tiempo completo**Responsibilities**:- Lead the development of realistic study timelines, from design through final study reporting on priority programs- Maintaining accuracy of clinical study timeline information in Company data control systems (e.g., Planisware (PPM)- Tracking, documenting, and ensuring key stakeholder involvement and timely delivery of clinical study...
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Principal Biostatistician, Fsp
hace 1 semana
Ciudad de México IQVIA A tiempo completo**Job Level**:FSP Principal Biostatistician **Location**:Home-based in Mexico **Why DSSS?** Data Sciences Staffing Solutions, DSSS, is a unit within IQVIA that provides our sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This means you get all the benefits of working for an industry leading global CRO while...
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México Syneos - Clinical and Corporate - Prod A tiempo completo**Description****Manager, Clinical Operations FSP team Client Based Mexico**Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings...
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México Syneos - Clinical and Corporate - Prod A tiempo completo**Description** **Manager, Clinical Operations FSP team Client Based Mexico** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model...
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Clinical Study Planning Senior Associate Manager
hace 2 semanas
Ciudad de México Parexel A tiempo completoExternal Job Description**Responsibilities**:- Lead the development of realistic study timelines, from design through final study reporting on priority programs- Maintaining accuracy of clinical study timeline information in Company data control systems (e.g., Planisware (PPM)- Tracking, documenting, and ensuring key stakeholder involvement and timely...
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Clinical Finance Analyst Ii/site Payments Specialist
hace 1 semana
Ciudad de México Parexel A tiempo completo**Parexel FSP** is looking for **Clinical Finance Analyst II** to join our team in **Argentina** or **Mexico**! **Job Summary** The **Clinical Finance Analyst II**is responsible for Clinical financial and accounting processes, such as processing invoices and payments to investigators and vendors; reconciling payments with sites, vendors and corporate...
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Clinical Study Team Assistant Ii
hace 3 días
Ciudad de México, CDMX Parexel A tiempo completoIn Parexel FSP we are currently looking for a Clinical Study Team Assistant II to join our team in Mexico. The position will be remote. The Clinical Study Team Assistant II (CSTA II) is an essential part of the Core Study Team and is responsible for driving and/or supporting key clinical trial tasks for assigned studies to ensure compliance with ICH-GCP,...
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Clinical Project Manager
hace 3 semanas
Ciudad de México Novartis A tiempo completoThe SSO Clinical Project Manager (CPM) is accountable for the day-to-day planning, executing and reporting, (from first site initiation visit to and including study site close-out), of assigned Global Drug Development (GDD) studies in compliance with Novartis processes and regulatory requirements.The CPM is the single point of contact and study team lead,...
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Clinical Trial Manager Any Therapeutic
hace 1 semana
Edo. de México Syneos Health Clinical A tiempo completo**Description****Clinical Trial Manager any therapeutic area-assigned to client Mexico**Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients...
