Clinical Trial Administrator
2 weeks ago
**PE Global is currently recruiting for a Clinical Trials Submission Associate for a leading multi-national Biotech client based in Uxbridge.**
***This will be an initial 12 month contract with strong possibility of extension.
The purpose of this role is to ensure technical compliance of our Clinical Trial submissions via the smooth compliant flow of information between all functional areas, local offices, external partners, and regulatory authorities.
**Role**:
Coordinate for Clinical Trial Submissions and Notifications in the state-of-the-art Regulatory Document Management System and maintain tracking systems.
Be the critical technical coordinator for Clinical Trial Submissions and Notifications through the EMA Clinical Trial Information System (CTIS), ensuring accurate and timely input of data into the EMA CTIS system for Clinical Trial Applications,Modifications and Notifications.
Be responsible for reviewing and triaging of Requests for Information from Health Authorities through CTIS to relevant cross functional teams.
Support the EU Regulatory Lead to prepare Submission Content Plans and documentation for regulatory deliverables, for the management of Clinical Trials.
Assist with definition, development, and implementation of processes to meet the evolving CTIS needs.
Raise, inform, and resolve any issues that may impact submission process or timelines within CTIS.
**Requirements**:
Knowledge and execution of CTA Processes in EU
Comprehensive understanding of the EU Clinical Trials Regulation, EU Clinical Trials Directive and ICH/GCP
EMA Clinical Trial Information System (CTIS) experience preferred
Knowledge of the drug development processes, Regulatory Affairs and Submission Management is highly desirable
Veeva Vault RIM experience preferred
Microsoft Office Suites experience
Ability to quickly learn new software, regulations, and processes
Proactive, innovative problem solver and well-organized teammate
Degree educated with experience in pharmaceutical company
Please click the link below to apply, or alternatively send an up to date CV to
-
Clinical Trial Associate
7 months ago
Uxbridge, United Kingdom Bristol-Myers Squibb Full time**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...
-
Senior Clinical Trial Director
3 weeks ago
Uxbridge, United Kingdom Regeneron Full timeAbout the RoleWe are seeking an experienced Senior Clinical Trial Director to join our team at Regeneron. As a leader in global clinical trial operations, you will be responsible for overseeing the execution of clinical trials, leading cross-functional study teams, and ensuring compliance with ICH/GCP and regulatory guidelines/directives. If you have a...
-
Clinical Trial Management Associate
2 weeks ago
Uxbridge, United Kingdom Gilead Sciences Full timeFor Current Gilead Employees and Contractors: Please log onto your Internal Career Site **Job Description**: Gilead has declared Oncology as one of the key therapeutic areas for future growth. Gilead is growing its pipeline in immune oncology through internal research, partnerships and acquisitions. The Clinical Operations team is responsible for the...
-
Clinical Trials Management Associate
3 weeks ago
Uxbridge, United Kingdom Gilead Sciences Full timeGilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams. **For Current Gilead Employees and...
-
Global Clinical Trial Lead
4 weeks ago
Uxbridge, United Kingdom Regeneron Full timeJob Overview:The Senior Manager Study Operations at Regeneron is responsible for the global execution of clinical trials from study design to close out. This role requires high-degree independence and accountability for timelines, budget, and ensuring compliance with SOPs and ICH/GCP.Key Responsibilities include:Leading cross-functional teams responsible for...
-
Senior Clinical Trials Management Associate
3 weeks ago
Uxbridge, United Kingdom Gilead Sciences Full timeGilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams. **For Current Gilead Employees and...
-
Lead Statistician for Clinical Trials
2 months ago
Uxbridge, United Kingdom Regeneron Pharmaceuticals, Inc Full timeRegulatory Policy Expert NeededWe are seeking a highly skilled Lead Statistician for Clinical Trials to join our team at Regeneron Pharmaceuticals, Inc. As a key member of our research team, you will be responsible for providing project leadership and programming support for processing data from clinical studies.You will work closely with cross-functional...
-
Clinical Trials Manager Position
4 weeks ago
Uxbridge, United Kingdom Gilead Sciences, Inc. Full timeGilead Sciences, Inc. is a global leader in the development of innovative therapies for patients with life-threatening diseases. We are committed to delivering high-quality clinical trials that meet regulatory requirements and ensure patient safety.Job Overview:This Clinical Trials Manager position offers a unique opportunity to work in a fast-paced...
-
Clinical Trials Supply Chain Specialist
2 weeks ago
Uxbridge, United Kingdom Park Street People Full time**Our client, a global pharmaceutical company, is currently looking for a Clinical Trials Supply Chain Specialist to join their team in Uxbridge on a full time, 12-month temporary basis (35 hours per week).** You will be responsible for managing the supplies for the clinical trials and/or drug development whilst ensuring that this is done in a...
-
Clinical Trial Supplies Coordinator
2 weeks ago
Uxbridge, United Kingdom CK GROUP Full timeCK Group are recruiting for a Clinical Trial Supplies Coordinator to join a global pharmaceutical company, based in Uxbridge on a contract basis for 12 months. **Hourly Salary**: £21.26 PAYE **Company**: Our client is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle...
-
Supply Chain Strategist for Clinical Trials
1 month ago
Uxbridge, United Kingdom Course Full timeJob Opportunity:Clinical Professionals invites applications from experienced professionals for the role of Supply Chain Strategist for Clinical Trials. We are looking for a highly skilled individual with a strong background in supply chain management and experience working in the pharma industry. The successful candidate will be responsible for developing...
-
Eu Clinical Trial Submission Sr Associate
7 months ago
Uxbridge South, United Kingdom Amgen Full time**HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you’re part of something bigger, it’s because you are. 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 biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering...
-
Clinical Trials Analysis Manager
3 weeks ago
Uxbridge, United Kingdom Regeneron Full timeWe are seeking a skilled Statistical Programming Specialist to join our team. As a Statistical Programming Specialist, you will be responsible for:Providing project leadership and programming support for data analysis from clinical studies.Designing and testing program logic, coding programs, and preparing program documentation.Supporting senior management...
-
Global Clinical Trial Management Specialist
4 weeks ago
Uxbridge, United Kingdom Gilead Full timeJoin Our TeamWe are a global biopharmaceutical company dedicated to making a difference in people's lives through the discovery and development of innovative medicines. Our team is passionate about delivering exceptional results and making a meaningful impact in the world of healthcare.As a Clinical Project Manager at Gilead, you will have the opportunity to...
-
Clinical Study Specialist
7 months ago
Uxbridge, United Kingdom Regeneron Pharmaceuticals Inc. Full timeThe Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. The CSS may be assigned to support the execution of one or more studies across a program. The CSS receives assignments from the Clinical Study Lead or Clinical Study Associate Manager. The CSS will support...
-
Senior Associate Clinical Contracting
3 weeks ago
Uxbridge, United Kingdom Amgen Inc. (IR) Full timeAbout the CompanyAmgen Inc. (IR) is a leading biotechnology company that discovers, develops, and delivers innovative human therapeutics. Our medicines have improved the lives of millions of patients worldwide.Job DescriptionWe are seeking a highly skilled Senior Contract Administrator to join our clinical contracts team. The successful candidate will be...
-
Clinical Study Specialist
4 weeks ago
Uxbridge, United Kingdom Regeneron Full time**Job Title:** Clinical Study Specialist**About the Role:**The Clinical Study Specialist provides technical and administrative support to clinical study teams responsible for clinical trial execution. This role involves working on the execution of one or more studies across a program, receiving assignments from the Clinical Study Lead or Clinical Study...
-
Clinical Project Associate
7 months ago
Uxbridge, United Kingdom Meet Recruitment Full time25 GBP - 25 GBP - Uxbridge, United Kingdom - Contract **Freelance Clinical Trial Associate Opportunity with Leading Global Pharma - UK Based** **Company Overview**: Join a dynamic and innovative global pharmaceutical company committed to advancing healthcare through groundbreaking research and development. We are seeking a highly motivated and experienced...
-
Clinical Study Specialist
7 months ago
Uxbridge, United Kingdom Regeneron Pharmaceuticals Inc. Full timeThe Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. The CSS may be assigned to support the execution of one or more studies across a program. The CSS receives assignments from the Clinical Study Lead or Clinical Study Associate Manager. The CSS will support...
-
Clinical Operations Manager
3 weeks ago
Uxbridge, United Kingdom Regeneron Full timeAbout the JobRegeneron is a leading biopharmaceutical company seeking an experienced Clinical Operations Manager to join our team. The ideal candidate will have a strong background in global clinical trial operations, including experience developing protocols and key study documents. As a member of our team, you will be responsible for leading...