Clinical Study Lead
4 weeks ago
Oxford Global Resources is hiring a Clinical Study Lead ( IVD experience is a must ) for temporary maternity leave.
As a Clinical Study Lead/Trial Manager you will be responsible for the development and execution of all study associated documentation including protocols, investigator brochure, informed consent, contracts, and reports, in compliance with relevant regulations, guidelines and SOPs.
The Trial Lead is responsible for creating and implementing study-specific clinical monitoring tools and documents; responsible for managing and tracking of clinical studies and budget, ensuring study completion in a timely manner within budget, escalating potential issues, setting up internal and external communications for correction, trouble shooting, and prevention planning.
Also:
Accountable for ensuring study site preparation, equipment, and training are compliant to the clinical protocol and organization’s SOPs.
Responsible for clinical study data entry and audit; adherence to all regulations including patient privacy per organizational policies.
Coordinating and supervising clinical monitoring team.
Providing Clinical Research Associates with project-specific training and having regular meetings with them.
Arranging and overseeing site visits. Accountable for managing site auditing or QC visits where necessary to address or improve quality.
Accountable for study close out procedures on study binders, datasets and study supplies working with CTAs, CRAs and Data / Statistic stakeholders for close-out documents and reviews.
Authors clinical study reports and study related submission documents to regulatory authorities, IRBs and local agencies in line with their requirements.
Accountable for supplementing data or documents for any queries from authorities during submission procedures.
Support CA function input for studies during audits e.g. BIMO, Pharma partner, FDA.
Education:
- Bachelor’s degree in, life sciences, biomedical engineering or nursing
- 5-8 years working experience with in vitro diagnostic devices company.
- Minimum 3 years working experience in Clinical Affairs/Operations is preferred, but experience in product development, quality and regulatory will be considered as part of overall professional experience.
- Working experience in clinical study management including good clinical practice is preferred . Yes
- Working knowledge of Regulatory requirements e.g. FDA CFR, ICH GCP, ISO14155, IVDR.
- Proficient with Microsoft Office Word and Excel.
- Understanding of Electronic Data Capture (eDC), eTMF and CTMS or similar clinical operations systems.
- Proficient English oral and written communication.
-
Senior Clinical Research Associate
4 weeks ago
United Kingdom Worldwide Clinical Trials, LLC Full timeWorldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular,...
-
Clinical Operations Lead
59 minutes ago
United Kingdom ARTO Full timeWe are seeking a highly motivated and experienced Clinical Project Lead to join our dynamic team. The Clinical Project Lead will play a pivotal role in the planning, execution, and management of clinical research projects focused on women's health. This individual will collaborate with cross-functional teams to ensure the successful implementation of...
-
Senior Clinical Research Associate
4 weeks ago
United Kingdom Worldwide Clinical Trials, LLC Full timeWho we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on...
-
United Kingdom IQVIA LLC Full timeAssociate Director, Study Lead, Single Sponsor Dedicated page is loaded Associate Director, Study Lead, Single Sponsor Dedicated Apply locations Reading, Berkshire, United Kingdom time type Full time posted on Posted 30+ Days Ago job requisition id R1397954 Job Purpose The Senior Study Leader is the leader of the cross-functional clinical trial team...
-
Clinical Service Manager
4 weeks ago
United Kingdom First Clinical Ltd Full timeDaily rate: ASAP Work with the Clinical Lead to provide general operational management and business support to the Surgery & Critical Care services. Working with the Clinical Lead the Clinical Service Manager is responsible for the operational / budgetary management and development of a defined range of clinical services. Leading the delivery of major...
-
Senior Medical Director, Oncology
2 days ago
United Kingdom Worldwide Clinical Trials Full timeSenior Medical Director, Oncology - EMEA - Homebased Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company’s scientific...
-
Clinical Trial Manager
4 weeks ago
United Kingdom IQVIA LLC Full timeIQVIA’s cFSP (sponsor-dedicated) team are seeking a Clinical Trial Manager to join us on our mission to drive healthcare forward. The Clinical Trial Manager will partner with the Clinical Trial Assistants, Clinical Research Associates, Central Trial Managers and Global Trial Managers to ensure overall study delivery at country level. RESPONSIBILITIES ...
-
GP Clinical Lead
4 weeks ago
United Kingdom Operose Health Ltd Full timeOperose Health are leaders in digital-first primary care providing high quality, accessible and resilient NHS services for our patients. We currently serve over 640,000 patients across 66 GP practices nationwide. Job Description Clinical Lead GP required at St Ann's Road Surgery St Ann's Road Surgery have an exciting opportunity for a General...
-
Clinical Commissioning Manager
4 weeks ago
United Kingdom First Clinical Ltd Full timeDaily rate: ASAP Effectively work alongside clinicians and other stakeholders to support the implementation of a CCG wide clinical commissioning programme. Provide clinical commissioning management support and expertise to the delivery of area wide commissioning priorities. Support the delivery of QIPP and CCG priorities, including opportunities for...
-
Practice Clinical Pharmacist
4 days ago
United Kingdom West Suffolk Clinical Commissioning Group Full timeAbout the Role Beccles Medical Centre is looking to welcome a qualified clinical pharmacist into our busy practice, to play a full and active role within our multi-disciplinary team. The role is offered on a full- or part-time basis, on a fixed term, 12 month contract. The post-holder will be a pharmacist, who will support and work alongside a team of...
-
Clinical Pharmacist
3 weeks ago
United Kingdom Interface Clinical Services, Ltd. Full timeAre you looking for a fulfilling career? Are you self-sufficient with a passion for delivering life impacting care? Want to be able to provide expert knowledge and support to health providers? Interface Clinical Services (an IQVIA business) are looking for pharmacists to join our team in Staffordshire. This innovative role requires a pharmacist with...
-
Medical Director
4 weeks ago
United Kingdom Worldwide Clinical Trials, LLC Full timeWorldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular,...
-
Clinical Trial Manager
4 weeks ago
United Kingdom IQVIA LLC Full timeIQVIA’s cFSP (sponsor-dedicated) team are seeking a Clinical Trial Manager to join us on our mission to drive healthcare forward. The Clinical Trial Manager will partner with the Clinical Trial Assistants, Clinical Research Associates, Central Trial Managers and Global Trial Managers to ensure overall study delivery at country level. Partner with...
-
Senior Medical Director, Oncology
4 weeks ago
United Kingdom Worldwide Clinical Trials, LLC Full timeWho we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on...
-
Clinical Research Assistant
2 weeks ago
United Kingdom IQVIA LLC Full timeClinical Research Assistant - Hull page is loaded Clinical Research Assistant - Hull Apply locations Hull, England, United Kingdom time type Part time posted on Posted 2 Days Ago job requisition id R1420773 Are you looking for an opportunity in Clinical Research? Do you want to work for an industry leading company. If so, come and join us - IQVIA are...
-
Clinical Scientist
1 week ago
United Kingdom Barrington James Full timeCompany Overview: We are a leading biopharmaceutical company dedicated to advancing the field of cell metabolism and developing innovative therapies across oncology and inflammation. Our mission is to transform patient care through the discovery and development of groundbreaking treatments that target key pathways of the immune system.Position Summary: We...
-
Clinical Scientist
2 weeks ago
United Kingdom Barrington James Full timeCompany Overview: We are a leading biopharmaceutical company dedicated to advancing the field of cell metabolism and developing innovative therapies across oncology and inflammation. Our mission is to transform patient care through the discovery and development of groundbreaking treatments that target key pathways of the immune system. Position Summary: ...
-
Clinical Scientist
2 weeks ago
United Kingdom Barrington James Full timeCompany Overview: We are a leading biopharmaceutical company dedicated to advancing the field of cell metabolism and developing innovative therapies across oncology and inflammation. Our mission is to transform patient care through the discovery and development of groundbreaking treatments that target key pathways of the immune system.Position Summary: We...
-
Clinical Scientist
2 weeks ago
United Kingdom Barrington James Full timeCompany Overview: We are a leading biopharmaceutical company dedicated to advancing the field of cell metabolism and developing innovative therapies across oncology and inflammation. Our mission is to transform patient care through the discovery and development of groundbreaking treatments that target key pathways of the immune system. Position Summary: We...
-
Clinical Scientist
1 week ago
United Kingdom Barrington James Full timeCompany Overview: We are a leading biopharmaceutical company dedicated to advancing the field of cell metabolism and developing innovative therapies across oncology and inflammation. Our mission is to transform patient care through the discovery and development of groundbreaking treatments that target key pathways of the immune system.Position Summary: We...