Clinical Trial Coord
hace 1 mes
Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global contract research organization (CRO).
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
- Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.
- As a PPD Clinical Trial Coordinator you will provide administrative and technical support to the Project Team. You will support audit readiness by ensuring files are reviewed on schedule detailed in the organization's WPD and department guidance document.
- At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
- Summarized Purpose:
- Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed on schedule detailed in the organization's WPD and department guidance document.
- Essential Functions:
- According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
- Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.
- Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.
- Supports the maintenance of study specific documentation and systems including but not limited to: study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans in appropriate system.
- Provides system support (i.e. GoBalto & eTMF).
- Supports RBM activities.
- Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
- Supports scheduling of client and/or internal meetings.
- Reviews and tracks local regulatory documents.
- Transmits documents to client and centralized IRB/IEC.
- Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
- Maintains vendor trackers.
- Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
- Assists with study-specific translation materials and translation QC upon request.
Education and Experience:
- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
- Bachelor's degree preferred.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
- Knowledge, Skills and Abilities:
- Ability to work in a team or independently as required
- Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
- Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
- Strong customer focus
- Flexibility to reprioritize workload to meet changing project timelines
- Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout
- Good English language and grammar skills and proficient local language skills as needed
- Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
- Ability to successfully complete PPD clinical training program
- Self-motivat
-
Clinical Trial Coord
hace 3 semanas
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completoWe are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving...
-
Clinical Trial Coord
hace 2 semanas
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completoOur team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world's most challenging health concerns. Our Clinical Research team, who powers our PPD clinical research portfolio, are part of our leading global...
-
Clinical Trial Manager
hace 2 semanas
Buenos Aires, Argentina IQVIA A tiempo completoClinical Trial Manager – Sponsor Dedicated. Clinical Trial Manager provides for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. These services lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agree upon...
-
Clinical Trial Assistant
hace 4 semanas
Buenos Aires, Argentina IQVIA A tiempo completo**Join us as a **Clinical Trials Assistant!**: **What You´ll Do** 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...
-
Clinical Trial Assistant
hace 4 semanas
Buenos Aires, Argentina Novasyte A tiempo completoJoin us as a Clinical Trials Assistant! - What You´ll DoPerform 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...
-
Clinical Trial Coordinator
hace 5 días
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completoFSP Clinical Trial Coordinator. Fully remote (2 days of office at GSK)
-
Clinical Trial Assistant
hace 2 semanas
Buenos Aires, Argentina Novasyte A tiempo completoJoin us as a Clinical Trials Assistant What You ́ll DoPerform 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...
-
Clinical Trial Manager
hace 3 semanas
Buenos Aires, Argentina Icon plc A tiempo completoAt 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 fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...
-
Clinical Trial Coord Ii
hace 4 semanas
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completoOur team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global...
-
Sr Clinical Trial Coord
hace 3 semanas
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completoWe are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving...
-
Clinical Trial Coord Ii
hace 1 mes
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completoWe are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving...
-
Clinical Trial Coord Ii
hace 4 semanas
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completoWe are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving...
-
Clinical Trial Manager
hace 2 semanas
Buenos Aires, Argentina Icon plc A tiempo completoAt 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 fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration,...
-
Sr Clinical Trial Coord
hace 2 semanas
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completoOur team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world's most challenging health concerns. Our Clinical Research team, who powers our PPD clinical research portfolio, are part of our leading global...
-
Clinical Trial Coord Ii
hace 2 semanas
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completoWe are vital links between an idea for a new medicine and the people who need it.We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving...
-
Sr Clinical Trial Coord
hace 2 semanas
Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completoWe are vital links between an idea for a new medicine and the people who need it.We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving...
-
Local Clinical Trial Assistant
hace 2 semanas
Buenos Aires, Argentina IQVIA A tiempo completoAre you a brave mind?It takes insight, curiosity, and intellectual courage to transform healthcare. It takes brave minds. By reimagining a world without the consequences of disease, brave minds bring powerful ideas to reality. Not intimidated by complexity, they see possibilities and explore the improbable.Join us as a Clinical Trials Assistant**:What You...
-
(Senior) Clinical Trial Manager
hace 1 mes
Buenos Aires, Argentina IQVIA A tiempo completoClinical Trial Manager – Sponsor Dedicated. Clinical Trial Manager provides for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. These services lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agree upon...
-
Buenos Aires, Argentina Lilly A tiempo completoWe’re looking for people who are determined to make life better for people around the world. The Trial Capabilities Associate provides clinical trial capabilities in support of clinical development. The associate is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing...
-
Sr. Associate-trial Capabilities Clinical
hace 2 meses
Buenos Aires, Argentina Lilly A tiempo completoAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
