(Senior) Clinical Study Lead

hace 4 semanas


En remoto, España Qiagen A tiempo completo

**Overview**
At the heart of QIAGEN’s business is a vision to make improvements in life possible.

We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.
Our most valuable asset are our employees - more than 6000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.
There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.
If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people’s lives, then QIAGEN is where you need to be.

Join us. At QIAGEN, you make a difference every day.

The (Senior) Clinical Study Lead (CSL) serves as a key member of the project core team with the goal to significantly contribute towards efficient launch of new or improved products.

Key responsibilities:

- Study design, strategy, planning (timeline, required resources and budget) for QIAGEN sponsored clinical studies, coordinating activities with stakeholders internally and externally and providing regular status reports.
- 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.
- Manage and track clinical studies and budget, ensuring study completion in a timely manner within budget, escalating potential issues, setting up and coordinating internal and external communications and meetings for correction, troubleshooting, and prevention planning.
- Identify, enlist and choose sites, and coordinate site management activities including ensuring study site preparation, equipment, and training are compliant to the clinical protocol and organization’s SOPs.
- Coordinate, supervise and train internal and external teams as required. Arrange and oversee site visits. Accountable for managing site auditing or QC visits where necessary to address or improve quality. Support during audits g. BIMO, Pharma partner, FDA
- Accountable for study close out procedures on study binders, datasets and study supplies working with CTAs, CRAs and Data/ Statistics stakeholders for close-out documents and reviews. Author clinical study reports and study related submission documents to regulatory authorities, IRBs and local agencies in line with their requirements and respond to queries.

**Position Requirements**
- Bachelor’s degree in, Life Sciences, Biomedical Engineering, Nursing or similar; or equivalent experience
- Significant employment experience within an in vitro diagnostic devices company, ideally in a Clinical Affairs/ Operations related role; other devices or pharmaceutical experience will be considered
- Working knowledge of regulatory requirements and industry working practices e.g. FDA CFR, ICH GCP, ISO14155, ISO20916, ISO13485, IVDR, CLSI guidance, design control
- Understanding of electronic Data Capture (eDC), eTMF and Clinical Trial Management System (CTMS) or similar clinical operations systems
- Experience of authoring clinical study documents e.g. Protocols, Investigator Brochure, Informed Consent Documents is desirable
- Willingness and availability to travel nationally and internationally as required: up to 20%

**What we offer**
At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.

QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.

Job Reference: EMEA04047


  • Senior Study Physician

    hace 4 días


    remoto, España Lifelancer A tiempo completo

    Job Description: As a Senior Study Physician at Lifelancer, you will play a key role in ensuring the success of our clinical trials. Your expertise and attention to detail will enable us to deliver high-quality results and maintain the trust of our clients and patients.About the Role: We are seeking a highly experienced Senior Study Physician to join our...

  • Study Manager

    hace 4 semanas


    En remoto, España Translational Research in Oncology A tiempo completo

    Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today. TRIO’s head office is in Edmonton, Alberta with operations all throughout...

  • Clinical Lead Ii/iii

    hace 4 semanas


    En remoto, España Premier Research A tiempo completo

    At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all....

  • Clinical Project Manager

    hace 3 semanas


    En remoto, España IQVIA A tiempo completo

    Job Overview - Please note for this role it is mandatory to have Cronos experience Senior Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Senior Project Lead is an essential member of the core project team leading the team and responsible...

  • Clinical Lead Iii

    hace 3 semanas


    En remoto, España Premier Research A tiempo completo

    At **Premier Research,** we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for...

  • Clinical Lead Ii/iii

    hace 4 semanas


    En remoto, España Premier Research A tiempo completo

    At **Premier Research,** we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for...


  • En remoto, España IQVIA A tiempo completo

    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 looking for a Clinical Research Coordinator. This fill-time (40 hours) role, is planned for 11 months and is to support the site in **Barcelona** in conducting a clinical trial in the field of **Cardiology**. As...


  • En remoto, España Allucent A tiempo completo

    These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in...


  • remoto, España Rho, Inc. A tiempo completo

    Job DescriptionWe're looking for a skilled Senior Clinical Project Manager to lead complex projects, conceptualizing the execution strategy for each component project. You'll need to prepare project management plans and other governance documents, recommend and implement operational strategies as well as risk management plans. Your responsibilities will...

  • Senior Project Manager

    hace 4 semanas


    En remoto, España Innovaderm Research A tiempo completo

    Senior Projects Managers are crucial to the success of Clinical Trials managed by Innovaderm. They are the main point of contact internally as well as externally, ensuring all activities and deliverables are completed on time, on budget, and as expected. Great project managers go further than creating project plans and following up on tasks. They show...


  • En remoto, España Parexel A tiempo completo

    The Clinical Operations Leader is responsible for coordinating the functional team members and their activities across all geographies, liaising with project leadership and the sponsor to ensure that the Clinical Operations deliverables (timeline, quality, productivity) are met. The Clinical Operations Leader has overall accountability for the execution of...


  • En remoto, España Parexel A tiempo completo

    Everything we do has the potential to impact patient lives, and our Clinical Research Associates (CRAs) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client and site satisfaction. As a CRA...


  • En remoto, España ICON A tiempo completo

    You will be supporting a long-term partnership with one of the most established pharmaceutical companies in the industry. Within this program you will find a culture focused on teamwork and camaraderie; where every member plays an integral part. You will have the opportunity to work on breakthrough technologies in the areas of cardiovascular, oncology,...


  • En remoto, España ICON A tiempo completo

    ICON 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...


  • En remoto, España ICON A tiempo completo

    ICON 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...

  • Start-up Lead 3

    hace 4 semanas


    En remoto, España ICON A tiempo completo

    ICON 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...


  • remoto, España Lifelancer A tiempo completo

    Job DescriptionAs a Remote Clinical Lead in Lifesciences, you will be responsible for leading clinical projects remotely within the State of Florida.Key ResponsibilitiesDevelop and execute project plans to ensure timely completionCollaborate with cross-functional teams to drive project successManage budgets and resources effectivelyRequirementsMid-senior...


  • remoto, España buscojobs España A tiempo completo

    Job Title: Senior Manager, Clinical Data ManagementJob Location: Boston, MA, USAJob Type: Full-timeAbout the Role:We are seeking an experienced Senior Manager, Clinical Data Management to join our team at Lifelancer. As a key member of our Life Sciences talent-hiring platform, you will be responsible for leading clinical data management initiatives and...

  • Senior Cra

    hace 4 semanas


    En remoto, España ICON A tiempo completo

    As a Clinical Research Associate (CRA) you will coordinate all aspects of the clinical monitoring and site management process in accordance with regulatory guidelines, local regulations and standard operating procedures. In this role you will be a decision maker, solving problems independently or as part of the client and ICON team. You will be managing...


  • remoto, España Lifelancer A tiempo completo

    About the RoleWe are seeking an experienced Senior Clinical Project Manager to lead clinical projects remotely within the State of Florida.ResponsibilitiesDevelop and execute project plans to ensure timely completionCollaborate with cross-functional teams to drive project successManage budgets and resources effectivelyRequirementsMid-senior level experience...