Clinical Trial Specialist
1 month ago
As a Clinical Trial Specialist at SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch, you will play a vital role in ensuring the quality and integrity of our clinical trials. Your primary responsibility will be to oversee all aspects of study site monitoring, including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, and liaison with vendors. You will also be responsible for site management as prescribed in project plans.
Responsibilities:
• Ensure the study staff conducting the protocol have received proper materials and instructions to safely enter patients into the study.
• Verify that informed consent procedures and protocol requirements are adhered to according to applicable regulatory requirements.
• Monitor data for missing or implausible data and ensure the integrity of data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
• Travel, including air travel, may be required and is an essential function of the job.
• Prepare accurate and timely trip reports.
• Interact with internal work groups to evaluate needs, resources, and timelines.
• Act as contact for clinical trial supplies and other suppliers (vendors) as assigned.
• Responsible for all aspects of registry management as prescribed in project plans.
• Undertake feasibility work when requested.
• Participate in and follow-up on Quality Control Visits (QC) when requested.
• Assist Senior CRA with managing investigator site budgets.
• Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives, and follow-up of SAEs.
• Independently perform CRF review; query generation and resolution against established data review guidelines on Company or client data management systems as assigned by management.
• Assist with training, mentoring, and development of new employees, e.g., co-monitoring.
• Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned.
• Perform other duties as assigned by management.
-
Clinical Trials Operations Specialist
4 weeks ago
Shanghai, Shanghai, China SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch Full timeSHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch is seeking a highly motivated Clinical Trials Operations Specialist to join our team. The successful candidate will play a critical role in the management and execution of clinical trials, ensuring seamless delivery and compliance with regulatory requirements.About the RoleThe...
-
Regulatory Compliance Specialist
4 weeks ago
Shanghai, Shanghai, China Thermo Fisher Scientific Full timeAbout the RoleWe are seeking a highly skilled Regulatory Compliance Specialist to join our team in Clinical Trial Operations. As a key member of our team, you will play a crucial role in ensuring that our clinical trials are conducted in accordance with regulatory requirements and industry standards.
-
Clinical Trials Specialist
4 weeks ago
Shanghai, Shanghai, China IQVIA Full timeJob SummaryWe are seeking a highly organized and detail-oriented Clinical Trials Specialist to join our team in Shanghai, China. As a key member of our clinical operations team, you will be responsible for ensuring the smooth execution of clinical trials from site initiation to close-out.About the RoleIn this role, you will collaborate with cross-functional...
-
Senior Clinical Trials Specialist
1 month ago
Shanghai, Shanghai, China IQVIA Full timeRole OverviewClinical Trial Coordinator-Shanghai is responsible for ensuring the smooth execution of clinical trials. This role involves tracking and reporting essential documents, ensuring the distribution of study tools and documents, and preparing and archiving clinical documents.ResponsibilitiesTrial and Site AdministrationTrack and report essential...
-
Clinical Trials Specialist
1 month ago
Shanghai, Shanghai, China Thermo Fisher Scientific Full timeJob SummaryWe are seeking a highly motivated and detail-oriented Clinical Trials Specialist to join our team at Thermo Fisher Scientific. In this role, you will be responsible for the preparation, review, and coordination of Country Submissions in line with our global submission strategy.Key ResponsibilitiesPrepare, review, and coordinate local EC...
-
Senior Data Analyst
1 month ago
Shanghai, Shanghai, China Lilly Full timeClinical Trials Data SpecialistWe are seeking a skilled Clinical Trials Data Specialist to join our team at Lilly.Key Responsibilities:Collaborate with statistical colleagues and study personnel to provide input to statistical analysis plans.Assist in and/or be accountable for selecting statistical methods for data analysis, authoring the corresponding...
-
Senior Clinical Trials Manager
1 month ago
Shanghai, Shanghai, China Thermo Fisher Scientific Full timeSummaryAs a Senior Clinical Trials Manager at Thermo Fisher Scientific, you will be responsible for managing clinical operations and ensuring the quality and integrity of clinical trials. Your primary goal will be to achieve the final clinical deliverable within the contractual time period specified by the customer.
-
Country Operations Specialist
4 weeks ago
Shanghai, Shanghai, China Lilly Full timeWe are seeking a highly skilled Country Operations Specialist to join our team at Lilly.Company OverviewLilly is a global pharmaceutical company dedicated to making life better for people around the world.Job DescriptionThe Country Operations Specialist will be responsible for providing clinical operational expertise to internal and external customers...
-
Clinical Trials Manager
1 month ago
Shanghai, Shanghai, China Thermo Fisher Scientific Full timeRole SummaryAs a Clinical Trials Manager at Thermo Fisher Scientific, you will be responsible for managing a team of clinical staff and managers across several countries or a geographic area. Your primary goal will be to ensure the timely execution of clinical deliverables with a focus on quality deliverables.Key ResponsibilitiesManage staff, including...
-
Clinical Trials Associate
1 month ago
Shanghai, Shanghai, China Clario Full timeJob SummaryThe Clinical Trials Associate will be responsible for coordinating all site and operational activities, from study start to study close, to ensure the timely delivery of high quality service deliverables for assigned studies.Key ResponsibilitiesAssist in preparation and reproduction of study materials during study start-up phase of clinical...
-
Senior RTSM Specialist
4 weeks ago
Shanghai, Shanghai, China Veeva Systems Full time**About Veeva Systems**Veeva Systems is a leading provider of cloud-based solutions for the global life sciences industry, with its headquarters located in the San Francisco Bay Area and offices in over 15 countries worldwide.**Job Overview**We are seeking a highly skilled Senior RTSM Specialist - Clinical Trial Efficiency Expert to join our RTSM team. The...
-
Scientific Research Assistant
4 weeks ago
Shanghai, Shanghai, China SHG Labcorp Pharmaceutical Research and Development (Shanghai) Co., Ltd. Full timeCompany OverviewSHG Labcorp Pharmaceutical Research and Development (Shanghai) Co., Ltd. is a leading pharmaceutical company that harnesses science for human good. Our mission is to improve health and lives across the globe.About UsWe have over 60,000 employees across 100 countries who are dedicated to delivering scientific breakthroughs and medical test...
-
SAS Programmer for Clinical Trials Development
1 month ago
Shanghai, Shanghai, China IQVIA Full timeResponsibilities:• Develop and maintain high-quality SAS programs for clinical trials using CDISC standards (SDTM and ADaM).• Collaborate with biostatisticians to design and implement statistical procedures for data analysis.• Ensure thorough understanding of relational database components and theory for efficient data management.• Apply strong...
-
Lead SAS Programmer
3 weeks ago
Shanghai, Shanghai, China IQVIA Full timeEstimated salary: $120,000 - $180,000 per yearAbout the RoleWe are seeking a highly skilled Lead SAS Programmer to join our team at IQVIA. In this role, you will be responsible for leading and executing complex programming tasks for oncology clinical trials.Key Responsibilities:Develop and implement efficient programming solutions using SAS and other...
-
Global Clinical Research Operations Specialist
4 weeks ago
Shanghai, Shanghai, China IQVIA Full timeJob SummaryWe are seeking a highly skilled Global Clinical Research Operations Specialist to join our team at IQVIA. As a key member of our clinical operations department, you will play a crucial role in the planning, execution, and monitoring of clinical trials.
-
Shanghai, Shanghai, China Danaher Full timeAbout UsDanaher is a world-class organization that combines science, technology, and operational capabilities to accelerate the real-life impact of tomorrow's science and technology.We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.Our global teams are...
-
Senior Clinical Monitoring Specialist
4 weeks ago
Shanghai, Shanghai, China Fortrea Full timeJob DescriptionWe are seeking a highly skilled Senior Clinical Monitoring Specialist to join our team at Fortrea in Xi'an. As a key member of our clinical operations team, you will be responsible for ensuring the successful execution of clinical trials.Key Responsibilities:Monitor study sites independently according to protocol monitoring guidelines, SOPs,...
-
Clinical Trials Operations Specialist
4 weeks ago
Shanghai, Shanghai, China SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch Full timeOverviewServe as a vital member of our global clinical development team at SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch. Our organization is dedicated to revolutionizing the drug and device development process, ensuring swift delivery of life-changing therapies to patients in need.
-
Clinical Research Associate
2 months ago
Shanghai, Shanghai, China Novo Nordisk AS Full timeAre you passionate about driving innovation in the pharmaceutical industry? Do you have a strong background in clinical research and a desire to make a meaningful impact on patient outcomes?The Clinical Research Associate (CRA) role at Novo Nordisk is a critical position that requires a unique blend of scientific knowledge, regulatory expertise, and...
-
Clinical Research Coordinator
2 months ago
Shanghai, Shanghai, China IQVIA Full timeJob Summary We are seeking a highly organized and detail-oriented Clinical Research Coordinator to join our team at IQVIA. The successful candidate will be responsible for coordinating and managing clinical trials, ensuring timely and accurate completion of tasks, and maintaining effective communication with stakeholders. Key Responsibilities Coordinate...