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Clinical Lead Ii/iii
hace 3 semanas
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. The role can be filled in Europe in the country, where we have our entity.
As a
**Clinical Lead** here at Premier Research, you’ll have the opportunity to work in diverse therapeutic areas and will be empowered to plan, schedule, manage, and deliver all clinical operations aspects of a study. You will manage all channels of communication and demonstrate enhanced judgement in selecting the proper mode of communication for the situation.
**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)
- 3 years of previous Clinical Oversight experience as a Clinical Lead
- Working knowledge of clinical financials including understanding of budgets, pass
- through and resource management
- 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
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
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