Clinical Trial Administrator Ii

Company Description PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. **Job Description**: Join our international team and be the...

Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...

Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...

**Position Overview**: The Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific drug/vaccine program. Develops and manages project plans which span from protocol development through database lock, archiving, and submission deliverables where applicable. Collaborates with...

**Description** Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. Provides administrative support for site activation activities. Aids the development of the critical path for site activation...

Clinical Research Manager **Category**:Clinical Development**Location**:Bogota, Cundinamarca, CO- **The Position** - As Clinical Research Manager you will manage and coordinate the implementation of local clinical projects, ensuring that are executed in a timely and effective manner, within budget and complying with regulatory requirements, Helsinki...

This role is accountable for execution and oversight of local operational clinical trial activities in compliance with International Conference on Harmonization Good Clinical Practice (ICH/GCP) and country regulations, company policies and procedures and with quality standards internally and externally. The person has ownership, oversight and impact on local...

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. You will be dedicated resource to one of our clients, be embedded in their working environment,...

**Practicante** **Clinical Trial Operations** - **Finanzas** ¿Estás listo para poner en práctica tus conocimientos, aprender e impactar en millones de vidas? ¡Si es así, esta es la oportunidad perfecta para que hagas parte de una empresa que le apuesta a la innovación, la experimentación y el crecimiento! El practicante de Global Clinical Trial...

**Individual Case Medical Review (ICMR)** The Scientist Level Clinical Safety Scientist (CSS) is responsible for support of safety reporting in clinical trials conducted in multiple therapeutic areas as part of investigational product development programs across early and late-stage development. Assists the protocol lead in safety reporting activities for...

**Work Schedule** Other **Environmental Conditions** Office **Based on**> Barranquilla or Cali **Experience,** 2/3 years onsite **Essential Functions and Other Job Information**:Essential FunctionsMonitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Qualifications**: Education and Experience: Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Qualifications**: Education and Experience: Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to...

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for...

This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. The CRM could be responsible for a particular study for...

This role is primarily accountable for the end-to-end performance and project management for assigned protocols in compliance with country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally. The Senior Clinical Research Manager could be responsible for a particular study for several...

This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. The CRM could be responsible for a particular study for...

**Job Description**: We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that...

**Job Description**: Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. **Position Overview**: Under the direction of the...

Senior Clinical Research Associate **Category**:Clinical Development**Location**:Bogota, Cundinamarca, CO- **The Position** - The Senior CRA will manage and execute the entire Novo Nordisk clinical trials process in compliance with internal SOPs including GCP-ICH and Colombia regulatory framework.**Activities and Responsibilities** - Clinical Trials...