Country Start Up Specialist

Role Description Study-Start-Up/QC Specialist: Purpose: Study Start Up/QC Specialist is responsible for country study start up (SSU) activities and performing quality review of essential documents. The SSU/QC Specialist is responsible for overseeing and leading SSU activities in collaboration with country team members (CLM and CRA) with the objective to...

**Regulatory & Start Up Specialist, cFSP - US Support** **Argentina - Full Home Based role** **Purpose**: The RSU Specialist 1 proactively drives and executes all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country: US. **Responsibilities** **Primary responsibilities include but are not...

Provide expertise for local regulations, ICH/GCP and relevant study and Sponsor requirements. - When delegated by Start-up Country Manager (SUCM), oversee and ensure quality data and audit readiness. - Anticipate and prevent issues and service failures from developing in their study, escalating when appropriate, negotiating when required. - Ensure efficient...

We are looking for a Regulatory & Start Up Specialist to join our FSP team in a Home Based role! What You´ll Do Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary...

We are currently looking for a Regulatory & Start Up Specialist to join our team in a Home Based role! What You´ll Do Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary...

En Bristol Myers Squibb, nos inspira una sola visión: transformar la vida de los pacientes a través de la ciencia. En oncología, hematología, inmunología y enfermedades cardiovasculares, y una de las líneas de producción más diversas y prometedoras de la industria, cada uno de nuestros apasionados compañeros contribuye a innovaciones que impulsan...

**Working with Us** Challenging. 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...

Job Summary: Join Medpace in CABA! As a Regulatory Submissions Coordinator you will have the opportunity to work within the Regulatory Submissions team, supporting our many projects and gaining vital experience in the study start up and site activation process of clincial trials. You will be a productive member of the team, and will be mentored and...

Job Summary: As a Regulatory Submissions Coordinator you will have the opportunity to work within Regulatory Submissions, supporting our many projects and gaining some vital experience. You will be a productive member of the team, and will be mentored and supported as you develop your skills. Working directly with Regulatory Submissions Coordinators, you...

390776BR **SSO Study Start-Up Manager**: Argentina **About the role** 100,000. That’s how many patients participate in our clinical trials at any given time. Global Clinical Operations (GCO) touches patients’ lives every day acting as a link between science and medicine. Envision the impact you could have! #GCO The SSO Study Start-Up Manager is...

**Job Overview** The **Regulatory & Start Up Specialist** will perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance...

Primary contact and liaison with investigative sites during study maintenance and -when assigned-, site start-up activities, with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB submissions are made within the timelines agreed with project management and Start-up team. Essential Job Duties: ...

**Trial and site administration**: - Tracking (e.g. essential documents) and reporting (e.g. Safety Reports) - Ensure collation and distribution of study tools and documents - Update clinical trial databases (CTMS) and trackers - Clinical supply & non-clinical supply management, in collaboration with other country roles - Manage Labeling requirements and...

**Job Overview** The **Regulatory & Start Up Specialist 2** will perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance...

CAS: As PPD CAS, the following will be the responsabilities: - Prepares, reviews and coordinates, under guidance, local regulatory submissions therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy. - Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients. - Provides...

Study Start up Lead **Category**:Clinical Development**Location**:Vicente Lopez, Buenos Aires, AR- Are you ready for a life-changing career at Novo Nordisk Argentina? Join us.- Working at Novo Nordisk is never just a job, it is an opportunity to have a life-changing career - you grow professionally.**The Position**Activities and Responsibilities** -...

Unleash Your Potential It takes curiosity and intellectual courage to accomplish great things. It takes brave minds to bring powerful ideas to reality and transform healthcare. We are a diverse, global team that shares a passion for collaboration and solving complex problems. Together, we help customers drive healthcare forward. Join IQVIA and see where...

Unleash Your Potential It takes curiosity and intellectual courage to accomplish great things. It takes brave minds to bring powerful ideas to reality and transform healthcare. We are a diverse, global team that shares a passion for collaboration and solving complex problems. Together, we help customers drive healthcare forward. Join IQVIA and see where...

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives. ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing...

Job Advert Posting At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives. ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by...