Associate Director, Study Data Manager

hace 7 días

Barcelona, 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 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?
Are you already

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