Associate Director, Clinical Project Lead

hace 5 días

Barcelona, España AstraZeneca A tiempo completo

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

**What You'll Do**:
Step into an exciting role as the Associate Director, Clinical Project Lead. Here, you'll lead Cross-Functional Clinical Sub-Teams, oversee study deliverables, manage timelines and budgets, and serve as the primary liaison between functional groups, investigator sites, and vendors. Your proactive management will ensure patient safety, data integrity, inspection readiness, and compliance. Depending on the project's scope, you may also be a member of the Core Team.

**The impact **you’ll** have**:

- ** Project Management**: Drive the planning, implementation, and execution of pivotal clinical trials. Oversee CROs and relevant study vendors, ensuring top-quality deliverables.
- ** CRO Management**: Manage CRO relationships, ensuring appropriate scope of work, oversight, and training
- ** Budgeting & Forecasting**: Plan, track, and forecast the Global Clinical Operations budget and timelines to support Clinical Development financial goals.
- ** Operational Execution**: Ensure operations align with Alexion SOPs, ICH Guidelines, and Good Clinical Practices (GCP) to guarantee data quality, integrity, and patient protection.
- ** Communication**: Share clinical studies performance data with management and scientific teams.
- ** Documentation**: Prepare and maintain required study and regulatory documents. Contribute to the development and approval of study documents.
- ** Continuous Improvement**: Conduct lessons learned exercises for continuous process improvement.

**Who you are**:

- ** Experience**: Over 10 years of clinical research experience, with at least 5 years leading the planning and execution of global clinical trials.
- ** Team Leadership**: Ability to lead cross-functional teams and manage CROs.
- ** Budgeting Skills**: Experience in developing study budgets, forecasting, and financial oversight.
- ** Education**: Bachelor’s degree or equivalent in clinical practice/health care, life sciences, or drug development.

**Preferred Qualifications**:

- ** Advanced Degree**: Master's, PhD, or MD degree desirable.
- ** PMP Certification**: Preferred.

At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.

  • Associate Project Director

    hace 2 semanas

    Barcelona, España Syneos Health Clinical A tiempo completo

    **Description** **Associate Project Director (Project Lead) - Oncology / General Medicine **open to any EMEA country** Come discover what our 25,000+ employees across 110 countries already know: **work here matters everywhere**. Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer...

  • Clinical Research Associate Ii

    hace 2 semanas

    Barcelona, España Syneos Health Clinical A tiempo completo

    **Clinical Research Associate II** **-** **(**22003353**)** **Description** **Clinical Research Associate II, Spain** Remote **Who We Are** Synteract®, a Syneos Health® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. We...

  • Associate Director, Clinical Regulatory Writing

    hace 1 semana

    Barcelona, España AstraZeneca A tiempo completo

    Role holders provide strategic leadership and communications expertise to clinical drug programs. They author clinical-regulatory documents and provide critical review to achieve high quality standards. They represent the skill on drug and non-drug projects. **Typical Accountabilities** The Clinical Regulatory Writing team provides expert communications...

  • Director, Clinical Regulatory Writing

    hace 1 semana

    Barcelona, España AstraZeneca A tiempo completo

    Role holders expertly drive strategic communications excellence to achieve successful submissions and approvals. They develop innovative best practices and improvement initiatives. **Typical Accountabilities** The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important...

  • (Senior) Clinical Development Director

    hace 1 semana

    barcelona, España Novartis A tiempo completo

    (Senior) Clinical Development Director - CV Join to apply for the (Senior) Clinical Development Director - CV role at Novartis Summary The Senior Clinical Development Director (CDD) in the Cardio Renal & Metabolic (CRM) Development Unit is responsible for leading the strategic planning and management of the assigned clinical program(s) from an end-to-end...

  • (Senior) Clinical Development Director

    hace 12 horas

    Barcelona, España Novartis A tiempo completo

    (Senior) Clinical Development Director - CV Join to apply for the (Senior) Clinical Development Director - CV role at Novartis Summary The Senior Clinical Development Director (CDD) in the Cardio Renal & Metabolic (CRM) Development Unit is responsible for leading the strategic planning and management of the assigned clinical program(s) from an end-to-end...

  • Clinical Research Associate

    hace 5 días

    Barcelona, España TFS HealthScience A tiempo completo

    Overview: CLINICAL RESEARCH ASSOCIATE CATALUÑA - SINGLE SPONSOR TFS HealthScience is excited to be expanding our SRS** **team and we are looking for an experienced, highly motivated regional Senior Clinical Research Associate (CRA) who shares our vision of providing clinical research excellence. Our **SRS** team is a highly experienced international group...

  • Associate Director, Global Dev Scientist

    hace 1 semana

    Barcelona, España AstraZeneca A tiempo completo

    **This opportunity is available at our Gaithersburg, MD, Waltham, MA (USA); Mississauga (CAN); or Barcelona (ESP) location.** Within Hematology R&D, we are committed to advancing the science to deliver life-changing medicines to patients most in need. With a combination-focused pipeline that exploits the power of six scientific platforms (Immuno-Oncology,...

  • [Oncology]Clinical Research Associate

    hace 1 semana

    Barcelona, España Fortrea A tiempo completo

    Clinical Research Associate II - FSP Team - BarcelonaJoin to apply for the Clinical Research Associate II - FSP Team - Barcelona role at Fortrea . Site management for clinical studies is conducted in accordance with Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans, and sponsor requirements. This includes verifying that...

  • Clinical Development Medical Director

    hace 2 días

    Barcelona, España Novartis A tiempo completo

    The Clinical Development Medical Director (CDMD) is the clinical leader of a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase), or a large, complex trial, under the leadership of the (Sr.) Provide clinical leadership and medical strategic input for deliverables in the assigned project/program, including...