Sr Clinical Trial Manager
3 semanas atrás
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 patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.Discover what our 29,000 employees, across 110 countries already know:WORK HERE MATTERS EVERYWHEREWhy Syneos HealthWe are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.Job responsibilitiesResponsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities.May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of the contractual obligations and parameters.Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope.Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.Participates and presents in key meetings such as Kick Off Meeting.Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members.Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones.Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan.Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study.Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress.Reviews the project oversight dashboards and other clinical trial systems to oversee site and patient activities.Understands the monitoring strategy required for the study and participates in the development of the study risk assessment plan.Reviews the content and quality of site and central monitoring documentation to ensure they represent site management activities and conduct.Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables.Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations.Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance.Provides feedback to line managers on staff performance including strengths as well as areas for development.May be assigned to larger, more complex trials or may coordinate clinical activities for a team of CTMs across a portfolio of projects.May coach and mentor CTMs regarding functional clinical delivery, evaluation of project risks, and action implementation.QualificationsWhat we’re looking forBachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.Demonstrated ability to lead and align teams in the achievement of project milestones.Demonstrated capability of working in an international environment.Demonstrated expertise in site management and monitoring (clinical or central).Preferred experience with risk-based monitoring.Demonstrates understanding of clinical trial management financial principles and budget management.Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.Must demonstrate good computer skills.Strong conflict resolution skills.Demonstrated ability to apply problem-solving techniques to resolve complex issues.Moderate travel may be required, approximately 20%.Get to know Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.Additional Information:Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks,
#J-18808-Ljbffr
-
Clinical Trial Manager- Oncology
3 semanas atrás
Brasília, DF, Brasil Worldwide Clinical Trials Tempo inteiro**Who we are** We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a...
-
Clinical Trial Manager
3 semanas atrás
brasília, Brasil ENGINEERINGUK Tempo inteiroAs a Clinical Trial Manager at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of treatments and therapies.What you will be doing:Collaborate with cross-functional teams to develop and implement comprehensive clinical trial protocols.Oversee and manage the...
-
Clinical Trial Manager
2 semanas atrás
Brasília, Brasil ICON Tempo inteiroAs a Clinical Trial Manager at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of treatments and therapies.What you will be doing:Collaborate with cross-functional teams to develop and implement comprehensive clinical trial protocols.Overseeing and managing...
-
Clinical Trial Manager
1 semana atrás
brasília, Brasil ICON Tempo inteiroAs a Clinical Trial Manager at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of treatments and therapies.What you will be doing:Collaborate with cross-functional teams to develop and implement comprehensive clinical trial protocols.Overseeing and managing...
-
Clinical Trial Manager
Há 2 dias
brasília, Brasil ENGINEERINGUK Tempo inteiroYou will need to login before you can apply for a job.Clinical Trial Manager - Medical AffairsView more categories View less categories Sector Health and Medical Role Manager Contract Type Permanent Hours Full TimeAs a Clinical Trial Manager at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data,...
-
Sr Clinical Trial Manager
3 semanas atrás
Brasília, Brasil Syneos Health, Inc. Tempo inteiroSr Clinical Trial Manager - Client Based: Brasil 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 patient...
-
Sr Clinical Trial Manager
3 semanas atrás
Brasília, Brasil Syneos Health, Inc. Tempo inteiroSr Clinical Trial Manager - Client Based: Brasil 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 patient to...
-
Senior Clinical Research Associate- SR CRA
4 semanas atrás
Brasília, Brasil CTI Clinical Trial and Consulting Services Tempo inteiroSenior Clinical Research Associate- SR CRA Job Category: Clinical MonitoringRequisition Number: SENIO001389Apply nowPosted: January 3, 2025Full-TimeOn-siteLocations Showing 1 locationAv. Francisco Matarazzo, n 1440Conj. 142-14 andar Agua BrancaSao Paulo, 05001903, BRADescription About CTICTI Clinical Trial and Consulting Services is a global,...
-
Senior Clinical Research Associate- SR CRA
3 semanas atrás
brasília, Brasil CTI Clinical Trial and Consulting Services Tempo inteiroSenior Clinical Research Associate- SR CRAJob Category:Clinical MonitoringRequisition Number:SENIO001389Apply nowPosted: January 3, 2025Full-TimeOn-siteLocationsShowing 1 locationAv. Francisco Matarazzo, n 1440Conj. 142-14 andar Agua BrancaSao Paulo, 05001903, BRADescriptionAbout CTICTI Clinical Trial and Consulting Services is a global, privately held,...
-
Local Trial Manager
4 semanas atrás
Brasília, Brasil Amgen SA Tempo inteiroHOW 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 leading...
-
Local Trial Manager
3 semanas atrás
brasília, Brasil Amgen SA Tempo inteiroHOW 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 leading...
-
Clinical Trials Empregos Em Brasil
Há 2 dias
Brasília, Brasil ICON Plc Tempo inteiroOverview: As a Clinical Trial Manager at ICON, you will play a pivotal role in designing and analyzing clinical trials , interpreting complex medical data, and contributing to the advancement of treatments and therapies.Responsibilities:Collaborate with the Study Management Team (SMT) to ensure regional/global clinical operations deliverables progress...
-
Clinical Trial Liasion
2 semanas atrás
Brasília, Brasil Parexel Tempo inteiroParexel FSP is looking for a Clinical Trial Liasion to join our team in Brazil. This role is pivotal in supporting the successful execution of breast cancer clinical trials. The CTL will achieve this by fostering robust relationships with clinical trial sites and investigators, with a key focus on optimizing patient enrolment. Collaboration is central to...
-
Clinical Trials Empregos Em Brasil
1 dia atrás
brasília, Brasil ICON Plc Tempo inteiroOverview:As aClinical Trial Managerat ICON, you will play a pivotal role in designing and analyzingclinical trials , interpreting complex medical data, and contributing to the advancement of treatments and therapies.Responsibilities:Collaborate with the Study Management Team (SMT) to ensure regional/global clinical operations deliverables progress according...
-
Clinical Trial Manager Full-Service Home Based LATAM
3 semanas atrás
brasília, Brasil Syneos Health, Inc. Tempo inteiroClinical Trial Manager Full-Service with experience in USA - Home Based LATAMUpdated:January 14, 2025Location:Brazil-Latin America - BRA-Home-BasedJob ID: 25001160Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into...
-
Local Trial Manager
4 semanas atrás
Brasília, Brasil myGwork - LGBTQ+ Business Community Tempo inteiroICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...
-
Local Trial Manager
3 semanas atrás
brasília, Brasil myGwork - LGBTQ+ Business Community Tempo inteiroICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...
-
Local Trial Manager
1 semana atrás
Brasília, Brasil Mygwork - Lgbtq+ Business Community Tempo inteiroICON plc is a world-leading healthcare intelligence and clinical research organisation.From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.With our patients at the centre of all that we do, we help to accelerate the development of...
-
Clinical Trial Associate
3 semanas atrás
Brasília, Brasil Allucent Tempo inteiroAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Clinical Trial Associate (CTA) to join our A-team (hybrid*/remote).As a Clinical Trial Associate at Allucent, you will be the...
-
Clinical Trial Associate
3 semanas atrás
brasília, Brasil Allucent Tempo inteiroAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Clinical Trial Associate (CTA) to join our A-team (hybrid*/remote). As a Clinical Trial Associate at Allucent, you will be the...