Clinical Data Management- Study Leading Roles

hace 2 semanas

Barcelona, España AstraZeneca A tiempo completo

**Clinical Data Management
- Study Leading roles**

**This is an office based role in Warsaw or Barcelona**

At AstraZeneca, we are guided in our work by a strong set of values, and we’re resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that transform lives. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you’re swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

**We are happy to announce recruitment process to join Late Phase Clinical Data Management team
- Study Leaders**

Clinical Data Managers (CDM) support and/or are accountable of data deliverables for assigned clinical studies and may be a specialist on CDM processes, standards and technology. Collaborate with vendors and link with a variety of departments on a local and global level to ensure each study is run in accordance to the specifics of the model. Maintains Business Continuity for processes and standards including integrity of the clinical database for the relevant studies.

**Why us?**
- **Being part of Core Study Team**:

- driving decisions for the whole study in data flow aspects
- ** Ongoing learning experience**:

- across different Therapeutic Areas and study stages
- ** E2E involvement in compound development
- **from early engagement to market registration
- ** Opportunities to implement your own ideas and solutions**:

- ** Flexible approach to working hours**:

- Stable employment with **great office atmosphere in a growing pharmaceutical company**:

- Employment contract with attractive benefit package (Multisport card, lunch card, medical and life insurance, pension plan, Catalyze recognition platform, additional days-off from company)
- Attractive salary **with annual bonus**:

- The opportunity to work and develop within an international company
- ** Extensive training opportunities** (internal and external) and industry conference participation
- Modern and comfortable office (great social area with PlayStation, billiard and table football)

**Typical daily activities**:

- ** Study leading activities** based on the relevant model and DM Vendor. This may include but is not limited to activities related to the study start up, conduct and closeout phases. (i.e., documentation review and/or creation, oversight on data cleaning and reviews, third party data management, important metrics and project timelines.).
- ** Driving data strategy
- **assessment of risks and mitigations related to Data Management in collaboration with different stakeholders (Clinical Operations, Medical Team, Centralized Monitoring, Biostats, Programming, External Data Providers etc.) on a study level
- Accountable for “real time” Data Management and overall quality and completeness of data
- ** Study status reporting** (e.g. provide data to clinical teams for performing medical and clinical reviews, coordination of data review, lab data review, etc.), collaboration with vendors regarding upcoming results and milestone achievements (i.e., snapshots, interim, and migrations); oversight of the data and documentation quality.
- ** Understands therapeutic area, indication or program specific data capture** standards and AZ standards, drive adherence to standards and processes for data quality and consistency, maintain an awareness of the external and internal models in order to flag for continuous improvement
- Provide input into activities associated with regulatory inspections/audits for assigned studies and to the selection and use of software systems, devices and vendors.
- Demonstrates willingness to seek ad hoc activities and knowledge sharing.

**Requirements**:

- Knowledge of Clinical Data Management and proven track records in the Biotech/Pharma/CRO industry
- Shown current understanding of Good Clinical Data Management Practices and relevant regulatory requirements
- Experience of clinical databases, different systems and electronic data capture (EDC preferred systems Medidata RAVE and/or ORACLE InForm) - understanding and experience in query management process and reconciliation activities
- Ability to work flexibly in a distributed team environment on simultaneous projects and proactively manage time to meet own goals.
- Excellent written and verbal communication skills, interpersonal and analytical skills and high attention to detail
- Ability to work independently and as part of a team

**Desirable**:

- Knowledge of clinical and pharmaceutical drug development process
- Demonstrated understanding of clinical data flow and data acquisition process
- Experience with effective external partner management

**Why AstraZeneca?**

Ar

  • Director, Clinical Data Management

    hace 4 días

    Barcelona, España AstraZeneca A tiempo completo

    **Director Clinical Data Management** **Hybrid work (3days from the office, 2 days from home)** The role holder will be responsible for developing the Clinical Data Management (CDM) strategy for either the therapeutic area/indication and/or strategic roles at DM organisation level. Will be responsible for CDM quality, management of external partners,...

  • Associate Director, Study Data Manager

    hace 2 semanas

    Barcelona, España AstraZeneca A tiempo completo

    **Clinical Data Management - Study Leading roles** **This is an office based role in Warsaw** At AstraZeneca, we are guided in our work by a strong set of values, and we’re resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From...

  • Principal Clinical Data Scientist

    hace 2 semanas

    Barcelona, España Syneos Health Clinical A tiempo completo

    **Description** **Principal Clinical Data Scientist** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to...

  • Sr Clinical Data Scientist

    hace 3 días

    Barcelona, Barcelona, España Syneos Health Clinical A tiempo completo

    DescriptionSenior Clinical Data ScientistSyneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our...

  • Principal/sr Clinical Data Scientist

    hace 4 semanas

    Barcelona, España Syneos Health Clinical A tiempo completo

    **Description** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their...

  • Associate Director, Study Data Manager

    hace 3 días

    Barcelona, Barcelona, España AstraZeneca A tiempo completo

    **Clinical Data Management Study Leading roles**This is an office based role in WarsawAt AstraZeneca, we are guided in our work by a strong set of values, and we're resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to...

  • Sr Clinical Data Scientist

    hace 3 semanas

    Barcelona, España Syneos Health Clinical A tiempo completo

    **Description** **Senior Clinical Data Scientist** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help...

  • Sr Clinical Data Scientist

    hace 3 semanas

    Barcelona, España Syneos Health Clinical A tiempo completo

    **Description** **Senior Clinical Data Scientist** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help...

  • Clinical Research Coordinator

    hace 4 semanas

    Barcelona, España Iqvia A tiempo completo

    Clinical Research Coordinator / Study Nurse - Sanlúcar de Barrameda Barcelona Barcelona, Catalunya, ES 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 / Study Nurse. This part-time (24 hours) role, is planned...

  • Clinical Research Coordinator

    hace 3 semanas

    Barcelona, España Iqvia A tiempo completo

    Clinical Research Coordinator / Study Nurse - Sanlúcar de Barrameda Barcelona Barcelona, Catalunya, ES 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 / Study Nurse. This part-time (24 hours) role, is planned...

  • Director Study Leader, Early Oncology Clinical

    hace 4 días

    Barcelona, Barcelona, España AstraZeneca A tiempo completo

    The Director Study Leader, Early Oncology Clinical is responsible for delivering a single or several smaller development programs or leading multiple studies or single complex/novel studies such as platform, basket, etc. The exact accountabilities will differ depending on the exact nature of the clinical program so a high degree of flexibility and autonomy...

  • Clinical Study Manager

    hace 2 meses

    Barcelona, España Veranex, Inc. A tiempo completo

    Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables...

  • Senior Clinical Data Manager

    hace 6 días

    Barcelona, España AstraZeneca A tiempo completo

    **Location**:Barcelona **About AstraZeneca** AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development, and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to...

  • Principal/sr Clinical Data Scientist

    hace 3 días

    Barcelona, Barcelona, España Syneos Health Clinical A tiempo completo

    DescriptionSyneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.Our...

  • Clinical Data Manager Ii

    hace 6 días

    Barcelona, España AstraZeneca A tiempo completo

    **Location**:Barcelona **About AstraZeneca** AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development, and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to...

  • Associate Clinical Research Manager. Barcelona or

    hace 2 semanas

    Barcelona, España Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to...

  • Clinical Trial Manager Ii

    hace 1 semana

    Barcelona, España Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager II** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient...

  • Clinical Trial Manager, Investigator Sponsored

    hace 4 días

    Barcelona, España Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager, Investigator Sponsored Studies - Home Based in Italy or Spain** The role is Sponsor dedicated. Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address...

  • Associate Clinical Data Manager

    hace 2 semanas

    Barcelona, España Recruiting Erasmus A tiempo completo

    **AstraZeneca** is an innovation-driven global biopharmaceutical company focused on the discovery, development, and commercialization of prescription medicines, primarily for the treatment of cardiovascular, renal, and metabolic, respiratory, and immunological, oncological and rare diseases. In line with our firm commitment to training and developing...

  • Global Study Manager

    hace 2 semanas

    Barcelona, España Morgan Philips Executive Search A tiempo completo

    Important Pharmaceutical Company is looking for a Global Study Manager - Early Oncology Clinical: The Global Study Manager is responsible for supporting the delivery of clinical studies ensuring quality and compliance. **Responsabilities**: Contribute to the development of study documents as appropriate as well as any updates/amendments, ensuring template...