Clinical Data Management- Study Leading Roles

hace 1 mes


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



  • 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...


  • 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,...


  • 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...


  • 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...


  • 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...


  • 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...


  • 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...


  • Barcelona, España AstraZeneca A tiempo completo

    **Role Description** 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...


  • Barcelona, 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...


  • Barcelona, España Syneos Health Clinical A tiempo completo

    **Description** **Senior Clinical Trial Manager** 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...


  • Barcelona, España Vall d'Hebron Institut de Recerca A tiempo completo

    VHIR-RRHH-FOR-003_vs01_ TheVall d'Hebron Research Institute (VHIR) is a public sector institution that promotes and develops the research, innovation and biosanitary teaching of the Vall d’Hebron University Hospital. Through the excellence of our research, we identify problems of society and we contribute to spread them around the world. In April...

  • Clinical Associate

    hace 2 días


    Barcelona, España ICON Clinical Research A tiempo completo

    • Recognize, exemplify and adhere to ICON's values which center around our culture of accountability, integrity, partnership, collaboration and excellence in delivery. • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business...


  • Barcelona, España Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager** 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...


  • Barcelona, España Icon A tiempo completo

    ICON 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. OVERVIEW OF THE ROLE: The Principal Clinical Data Science Lead role is part of the Early Phase Data...


  • Barcelona, España Syneos - Clinical and Corporate - Prod A tiempo completo

    **Description** Sponsor Dedicated Clinical Trial Manager II/ Sr CTM - Home Based in SPAIN **Experience as CTM in the management of global/multiple-countries studies and different types of vendors is required.** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique...

  • Global Study Director

    hace 4 semanas


    Barcelona, España AstraZeneca A tiempo completo

    **Short **r**ole **d**e**s**cripti**o**n** The **Global Study Director (GSD)** is a business-critical role within Study Management Late, Biopharmaceuticals whose main accountability is the operational planning and delivery of high priority and complex clinical studies within a program, or across programs. The **GSD** is responsible for leading a...


  • Barcelona, España Bayer A tiempo completo

    At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...


  • Barcelona, España AstraZeneca A tiempo completo

    **Location: Barcelona - On-Site** **Short role description** The GSM is a member of extended global study team supporting delivery of clinical studies within Late Development Oncology (LDO) to time, cost and quality, from Clinical Study Protocol (CSP)development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR) to...


  • Barcelona, España Astrazeneca Gmbh A tiempo completo

    Location: Barcelona, Spain (on-site) / Able to be office based (3 days per week) in the Barcelona office from day 1. For candidates living in other locations requiring relocation, candidate should be able to relocate and start in the AZ role within 2 months once offer is accepted. AZ will not provide relocation package for this role. The Global Study Manager...


  • Barcelona, España AstraZeneca A tiempo completo

    **Location: Barcelona, Spain (on-site)** The **Global Study Associate Director (GSAD)** is a business-critical role within Study Management R&D, Development Operations, whose main accountability is the delivery of clinical studies. The **GSAD** is responsible for leading a cross-functional study team (core and extended) and for providing the team with...