Local Trial Manager

2 semanas atrás

São Paulo, Brasil IQVIA Tempo inteiro

Internal Job Description

Local Trial Management services provides local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned protocol(s) at the country level from start-up through to database lock and closeout activities. Further, services will ensure the local trial team is delivering quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), and regulatory requirements.

**Tasks & Responsibilities**:

- Services rendered will adhere to applicable Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements.
- Prepares or contributes to high level budget estimate in response to Request for Service’s followed by detailed budget proposal. Ensures overall contract management, including review and approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.
- Act as primary company contact for assigned trial at the country level and ensures local/country team is tracking project progress against planned timelines and monitors patient recruitment rate to ensure that target enrollment will be met across the allocated countries. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
- Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. Participates in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits. Escalates corrective and preventive actions (CAPA) to GTL MAO and CPL when the trial deviates from plans and communicates study progress and issues to study management teams and business partners.
- Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
- Contributes to patient understanding of protocol and patient safety by contributing to the review of country specific informed consent in accordance with procedural document/templates. This includes reviewing and managing site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.

**Essentials Requirements**:

- BA/BS degree.
- Degree in a health or science related field.
- Minimum of 2 years of local trial management experience in the pharmaceutical industry or CRO and previous experience as Clinical Research Associate.
- Specific therapeutic area experience may be required depending on the position.
- Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.
- Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home according to business needs.
- Excellent decision-making and string financial management skills.
- Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate.

  • Local Trial Manager

    Há 4 dias

    São Paulo, Brasil Amgen Tempo inteiro

    **HOW MIGHT YOU DEFY IMAGINATION?** You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s...

  • Local Trial Manager

    2 semanas atrás

    Sao Paulo, Brasil Amgen Tempo inteiro

    **HOW MIGHT YOU DEFY IMAGINATION?** You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology...

  • Lead Trial Delivery Manager

    Há 4 dias

    São Paulo, Brasil Johnson & Johnson Tempo inteiro

    **Function** - R&D Operations **Sub function** - Clinical Trial Project Management **Category** - Senior Analyst, Clinical Trial Project Management (P6) **Location** - São Paulo / Brazil **Date posted** - Jun 13 2025 **Requisition number** - R-017796 **Work pattern** - Fully Remote Description **Job Function**: R&D Operations ** Job Sub...

  • Clinical trial manager

    3 semanas atrás

    São Paulo, Brasil IQVIA Tempo inteiro

    Clinical Trial Manager – Sponsor Dedicated. Clinical Project Management services provide management of a clinical trial (s) in a regional level. Services/deliverables include operational oversight of assigned project(s) at the regional level for end-to-end project management from start-up through to closeout activities. Tasks & Responsibilities: Services...

  • Clinical Trial Manager

    2 semanas atrás

    São Paulo, São Paulo, Brasil IQVIA Tempo inteiro R$60.000 - R$120.000 por ano

    Clinical Trial Manager – Sponsor Dedicated.Clinical Project Management services provide management of a clinical trial (s) in a regional level. Services/deliverables include operational oversight of assigned project(s) at the regional level for end-to-end project management from start-up through to closeout activities.Tasks & Responsibilities:Services...

  • Clinical Trial Manager

    Há 3 dias

    São Paulo, Brasil ICON Tempo inteiro

    Clinical Trial Manager in IPH ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

  • Clinical Trial Manager

    Há 6 dias

    São Paulo, São Paulo, Brasil ICON plc Tempo inteiro R$90.000 - R$120.000 por ano

    Clinical Trial Manager (FSP - Sponsor Dedicated)ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Clinical Trial Manager to...

  • Clinical Trial Manager

    4 semanas atrás

    São Paulo, Brasil IQVIA LLC Tempo inteiro

    Clinical Trial Manager - Sponsor Dedicated page is loaded## Clinical Trial Manager - Sponsor Dedicatedlocations: São Paulo, Brazil: Mexico City, Mexicotime type: Full timeposted on: Posted Todayjob requisition id: R **Clinical Trial Manager – Sponsor Dedicated.**Clinical Project Management services provide management of a clinical trial (s) in a regional...

  • Clinical Trial Oversight Manager

    Há 4 dias

    São Paulo, Brasil Amgen Tempo inteiro

    **Join Amgen’s Mission of Serving Patients** At Amgen, if you feel like you’re 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...

  • Clinical Trial Assistant

    3 semanas atrás

    São Paulo, Brasil Johnson & Johnson Innovative Medicine Tempo inteiro

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across...