Clinical Lead Ii/iii
hace 6 meses
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. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.
We’re looking for a
**Clinical Lead II/III** to join our
**Clinical Management **team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.
- **We are Built for You.** We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- **We are Built by You.** Your ideas influence the way we work, and your voice matters here.
- **We are Built with You.** As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM.** Join us and build your future here.**
**What you’ll be doing**:
- Manage clinical portion of the trial in a patient centric approach and proactively identifying risk, potential patient safety events, and maintain oversight for data integrity.
- Successfully oversee and monitor CRAs in a matrix environment with a focus on quality and timely deliverables; address issues with appropriate team and line manager; direct involvement in selection and activation of investigative sites; ensure the timely completion of all visit reports
- Proactively maintain compliance through identification/mitigation of risk and ensuring adherence to ICH, GCP, SOPs, and the study protocol over the life of the study.
- Drive the successful activation of trial sites according to time, quality/scope and budget parameters
- Plan and drive both patient recruitment and retention together with the project manager (PM), inclusive of preparing and executing a site and patient recruitment and retention plan/strategy to motivate recruitment in order to meet milestone.
- Drive the clinical team forward to meet contractual milestones such as first site activated, first patient in, last patient in, and database lock
- Deliver and coordinate appropriate and timely training to the Premier clinical team and enlist therapeutic assistance where applicable to ensure the validity, correctness, and completeness of the clinical data
- Complete/contribute to the review of the protocol/study design, informed consent forms and be a reference point for CRAs and investigative sites
- Work with the Data Management team to identify data related issues and risks to clinical activities; assist in the development of mitigation plans to minimize risk
- Work with Project Management and Financial Analyst to accurately forecast clinical tasks including monitoring visits
- Actively participate in Bid Defense activities
**You’ll need this to be considered**:
- Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field
- 7 years + of clinical research experience as a CRA, CL or PM (of which at least 3 years onsite monitoring)
- 4 years+ of previous Clinical Oversight experience as a Clinical Lead
- Working knowledge of clinical financials including understanding of budgets, pass
- through and resource management
- Experience on the CRO side is preferred
- Neurology (Parkinson's Disease) or Oncology (Prostate Cancer) is essential
- Strong knowledge of ICH / GCP regulations; advanced knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
- Fluent verbal and written English as well as the local language(s) required
- Known for being customer-focused in approach to work and communications with the ability to professionally interact with sites
- Maintains a positive, results orientated work environment; excellent team player, collaborative and able to build an effective team
- Excellent organizational and time-management skills, able prioritize work to meet deadlines
**Why choose Premier Research?**
- Premier Research is more than a company - it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our cultural anchors - Caring & Empathy, Empowerment, Aspiration, One Team - mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedicat
-
Clinical Lead Iii
hace 6 meses
En remoto, España Premier Research A tiempo completoAt **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...
-
Initiation Clinical Research Associate Ii
hace 7 meses
En remoto, España Parexel A tiempo completoThe **Initiation Clinical Research Associate II **(**iCRA II**) specialises in performing all study start up activities for a clinical trial. You will participate in Pre SIV activities and be assigned & accountable for managing and driving the strategy for the Pre SIV / start up tasks of the study. The iCRA II can also support protocol amendments if...
-
Clinical Research Associate Ii
hace 5 meses
En remoto, España Allucent A tiempo completoThese 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...
-
Cra Ii/ Senior Clinical Research Associate
hace 5 meses
En remoto, España Meet Recruitment A tiempo completoCompetitive - Milan, Spain - Permanent CRA II/ Senior Clinical Research Associate - Midsized CRO - Remote - Spain - CRA II/ SCRA - Fascinating projects and therapeutic area exposure - Fast progression due to tailored training programmes - Excellent work environment Company Background: Opportunity to join a full-service CRO with offices spanning six...
-
Cra Ii
hace 5 meses
En remoto, España ICON A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. As a Clinical Research Associate you will be joining the world’s largest & most comprehensive...
-
Senior Clinical Research Associate
hace 6 meses
En remoto, España ICON A tiempo completoAs a Senior Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing**: - You will monitor multiple Phase I, II, III & IV clinical trial sites, across different therapeutic areas. Assist other CRAs with co-monitoring activities...
-
Project Manager Ii
hace 5 meses
En remoto, España Premier Research A tiempo completoPremier Research is looking for a** Project Manager II** to join our** Oncology **team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the...
-
(Senior) Clinical Study Lead
hace 6 meses
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...
-
Study Operations Manager Ii
hace 6 meses
En remoto, España Pfizer A tiempo completoThe Study Operations Manager II is responsible for study and regional/country level activities from study startup through conduct and study close. The Study Operations Manager will be assigned one or more studies and will be tasked with taking on several responsibilities in support of the larger Study Management deliverables. The Study Operations Manager II...
-
Fuctional Data Lead
hace 5 meses
En remoto, España Red Commerce A tiempo completoRED is currently looking for a **Functional Data Lead** for our long-standing end customer. **Title**: Functional Data Lead **Start**: ASAP **Duration**: 6 months contract + possible extension **Location**: remote with occasional travelling **Language**: English **Key Responsibilities**: - Preparation of business cases and provide support for the...
-
Functional Data Lead
hace 5 meses
En remoto, España Red Commerce A tiempo completo**Functional Data Lead** RED is currently looking for a Functional Lead for our long-standing end customer. Title: Functional Data Lead Start: ASAP Duration: 6 months contract + possible extension Location: remote with occasional travelling Language: English **Requirements**: Proven experience in clinical data migration, within the pharmaceutical or...
-
Associate Clinical Project Manager
hace 5 meses
En remoto, España IQVIA A tiempo completoJob Overview Associate 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 Associate Project Lead is a member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with...
-
Clinical Project Manager
hace 6 meses
En remoto, España IQVIA A tiempo completoJob 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 Trial Manager
hace 6 meses
En remoto, España ICON A tiempo completoICON 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...
-
Manager, Global Analytics, Clinical Trials
hace 5 meses
En remoto, España IQVIA A tiempo completo**Job Overview** Perform, manage and co-ordinate activities for complex opportunities/ projects. Utilize multiple data sources to perform analysis, formulate recommendations and present to internal and external stakeholders. Train and mentor junior staff and country leads. Make recommendations and lead process improvements. **Essential Functions** -...
-
Clinical Trial Leader
hace 5 meses
En remoto, España Parexel A tiempo completoSpain, Remote **Job ID** R0000019423 **Category** Clinical Trials **ABOUT THIS ROLE**: **Role Purpose** The CTL provides leadership and direction to the trial team and is accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and KPI’s. They are responsible for steering and directing clinical...
-
Clinical Project Manager
hace 5 meses
En remoto, España IQVIA A tiempo completo**Job Overview** 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 Project Lead is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs,...
-
Cra Ii
hace 5 meses
En remoto, España ICON A tiempo completoICON 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...
-
Senior Project Manager
hace 6 meses
En remoto, España Innovaderm Research A tiempo completoSenior 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...
-
Sma Ii
hace 5 meses
En remoto, España ICON A tiempo completoAs a Clinical Trial Management Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing**: - Site level ISF and pharmacy binder creation and availability at site prior to SIV. The cCTA ca be the link between the CRA and the rCTA (regional CTA) in...