Local Trial Manager

hace 2 semanas

Madrid, Madrid, España Johnson & Johnson A tiempo completo

Position Summary:


The Local Trial Manager II (LTM II) is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries.

The LTM II is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents.

The LTM II is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.


The LTM II actively contributes to process improvement; training and mentoring of Clinical Trial Assistants (CTA), Site Managers (SM) and LTM I roles.

The LTM II may have some site management responsibilities.


The LTM II may also perform the role of Clinical Trial Manager (CTM)/Global Trial Lead (GTL) for single country as described in GCO procedural documents.


Principal Responsibilities:

  • Collaborate with Functional Manager (FM)/Clinical Research Manager (CRM) for country protocol feasibility (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and CTM/GTL. Implements any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommends suitable sites for selection to participate in trial.
  • Collaborates with the Global Product Lead (GPL), CTM/GTL, local management/Country Head and other study team member to select final site list.
  • Contributes input to the study management documents at a country level or initiates development of
these documents for a single country trial, as per SOPs

  • Leads and coordinates local trial team activities in compliance with SOPs, other procedural documents and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget.

Including but not limited to:
development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.

  • Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.
  • Maintains and updates trial management systems. Uses study tools and management reports available to analyse trial progress.
  • Monitors country progress and initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams.
  • May submit requests for vendor services and may support vendor selection.
  • In certain situations, may assist in negotiation of trial site contracts and budgets. Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered -within budget. Adheres to finance reporting deliverables and timelines.
  • Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting
  • Conducts local trial team meetings and provides or facilitates SM training when needed (i.e. implementation of study amendment-and changes in study related processes).
  • Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the CTM/GTL and FM as needed.
  • Reviews and approves site and local vendor invoices as required. Manages local study supply, as required.
  • Prepares country specific informed consent in accordance with procedural document/templates. Reviews and manages site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.
  • Organizes and ensures IEC/HA approvals, if applicable, and ensure that the trial is in compliance with local regulatory requirements.
  • Works with SM to ensure CAPA is implemented for audits and inspection or any quality related visits
  • Complies with relevant training requirements.
  • Acts as primary local/country contact for a trial. Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, study trial coordinators and other site staff; and internal stakeholders, including Medical Affairs and Marketing for Medical Affairs trials.
  • Actively contributes to process improvement, training and mentoring of CTAs, SM and other LTMs.
  • Conducts accompanied site visits with SM as delegated by FM.
  • May assumes additional responsibilities or special initiatives such as "Champion" or "Subject Matter Expert".
  • May represents functional area in process initiatives as req

  • Local Trial Manager

    hace 2 semanas

    Madrid, Madrid, España Amgen Sa A tiempo completo

    If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to becoming one of the world's leading biotechnology companies. We are global collaborators who achievetogether—researching,manufacturing, and delivering ever-better products that reach over 10 million...

  • Local Trial Manager

    hace 2 semanas

    Madrid, Madrid, España Amgen SA A tiempo completo

    If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to becoming one of the world's leading biotechnology companies. We are global collaborators who achievetogether—researching,manufacturing, and delivering ever-better products that reach over 10 million...

  • Clinical Trial Manager

    hace 2 semanas

    Madrid, Madrid, España Al Solutions A tiempo completo

    Clinical Trial Manager Start up CROSpain.Taylor Young is working with a Start-up CRO that is looking for a Clinical Trial Manager to join a highly experienced clinical operations team in Spain.My client has very strong core values which results in a great work environment and very happy staffThis role is working remotely in Poland. This is a unique...

  • Clinical Trial Manager

    hace 2 semanas

    Madrid, Madrid, España Al Solutions A tiempo completo

    Clinical Trial Manager Start up CROSpain.Taylor Young is working with a Start-up CRO that is looking for a Clinical Trial Manager to join a highly experienced clinical operations team in Spain.My client has very strong core values which results in a great work environment and very happy staffThis role is working remotely in Poland. This is a unique...

  • Clinical Trial Manager

    hace 2 semanas

    Madrid, Madrid, España Icon Strategic Solutions A tiempo completo

    As a Clinical Trial Manager you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.The CTM manages assigned clinical trials, leads the FSE trial teams in order to ensure highquality execution of the trials and deliverables within all countries in the FSE. The CTM enables the Adjacent...

  • Global Trial Manager

    hace 2 semanas

    Madrid, Madrid, España Novo Nordisk A tiempo completo

    Global Trial ManagerCategory:Clinical DevelopmentLocation:Madrid, Comunidad de Madrid, ES- In Novo Nordisk we are looking for ambitious Global Trial Managers to join our international clinical trial teams as we pursue new and exciting therapeutic areas and optimised ways of working. If you can help us bring new treatments to patients, faster and smarter, by...

  • Global Trial Manager

    hace 2 semanas

    Madrid, Madrid, España Novo Nordisk A tiempo completo

    Do you wish to be part of an international clinical trial team as we set out on a journey into new and exciting therapeutic areas and ways of working? Can you help us bring new treatments to patients, faster and smarter, by leading and optimizing trial work within your area of expertise?The positionAs a Global Trial Manager within Rare Disease & Advanced...

  • Clinical Trial Manager

    hace 2 semanas

    Madrid, Madrid, España Precision For Medicine A tiempo completo

    We have current opportunity for an experienced Clinical Trial Manager in Europe Join our growing team.Precision for Medicine is a precision medicine CRO. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data...

  • Clinical Trial Manager

    hace 2 semanas

    Madrid, Madrid, España Bristol-Myers Squibb A tiempo completo

    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • Clinical Trial Manager

    hace 2 semanas

    Madrid, Madrid, España Remote Jobs A tiempo completo

    We have current opportunity for an experienced Clinical Trial Manager in Europe Join our growing team.Precision for Medicine is a precision medicine CRO. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data...

  • Cdc Trial Manager

    hace 2 semanas

    Madrid, Madrid, España Novo Nordisk A tiempo completo

    Are you passionate about Trial Management and would like to be part of the patient's life change?Do you want to be part of our Clinical Development Centre (CDC) team integrated by Spain, France and Portugal?The position could be based in any of these three cities (Madrid, Paris or Lisbon).The PositionAs Trial Manager you will lead the project management of...

  • Trial Technician

    hace 2 semanas

    Madrid, Madrid, España Enza Zaden A tiempo completo

    Reporting to:Team Lead External Trials / (Senior) Product Specialist / (Senior)Breeder/ Station ManagerPurpose:Crop care at external trial location and collection of trial data of breedingand/or screening trials.Geographical Scope:1 countryOperational Level:OperationalKey Accountabilities:Sowing, young plant raising and planting of external trials.Care and...

  • Clinical Trial Manager

    hace 2 semanas

    Madrid, Madrid, España Precision Medicine Group A tiempo completo

    We have current opportunity for an experienced Clinical Trial Manager in Europe Join our growing team.Precision for Medicine is a precision medicine CRO. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data...

  • Clinical Trial Manager

    hace 2 semanas

    Madrid, Madrid, España Icon A tiempo completo

    As a Clinical Trial Manager you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. The CTM manages assigned clinical trials, leads the FSE trial teams in order to ensure high quality execution of the trials and deliverables within all countries in the FSE. The CTM enables the Adjacent...

  • Clinical Trial Manager

    hace 2 semanas

    Madrid, Madrid, España AbbVie A tiempo completo

    Company DescriptionJob Description SMA III**As a Clinical Trial Manager, you will be part of a dynamic, centralized study management team that is responsible for the execution of our global clinical trials and a key member of the study team.The Clinical Trial Manager works as an independent, contributing member of a cross-functional and global partnership to...

  • Clinical Trial Manager

    hace 2 semanas

    Madrid, Madrid, España Precision Medicine Group A tiempo completo

    We have current opportunity for an experienced Clinical Trial Manager in Europe Join our growing team.Precision for Medicine is a precision medicine CRO. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data...

  • Clinical Trial Supplies Manager

    hace 2 semanas

    Madrid, Madrid, España Syneos Health Clinical A tiempo completo

    DescriptionClinical Trial Supplies Manager (Master Planner)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 the customer and the...

  • Clinical Trial Manager

    hace 2 semanas

    Madrid, Madrid, España Precision for Medicine A tiempo completo

    We have current opportunity for an experienced Clinical Trial Manager in Europe Join our growing team.Precision for Medicine is a precision medicine CRO. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data...

  • Clinical Trial Manager

    hace 2 semanas

    Madrid, Madrid, España Precision Medicine Group A tiempo completo

    We have current opportunity for an experienced Clinical Trial Manager in Europe Join our growing team.Precision for Medicine is a precision medicine CRO. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data...

  • Clinical Trial Manager

    hace 4 semanas

    Madrid, Madrid, España Precision Medicine Group A tiempo completo

    We have current opportunity for an experienced Clinical Trial Manager in Europe Join our growing team.Precision for Medicine is a precision medicine CRO. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data...