Associate Director - Project / Study Data Manager

Poland - Warsaw

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Job Title: Associate Director Project Data Manager

Warsaw, hybrid work (3 days from the office, 2 days from home/weekly)

Introduction to Role:

Join us as an Associate Director Project Data Manager, where you'll be responsible for the oversight of Clinical Data Management (CDM) delivery of high-quality data via external partners or internally run studies for one or more assigned projects. You'll also act as an expert on CDM projects and technology outside of CDM program support, maintaining an up-to-date awareness of trends/changes in external CDM approaches. This role offers the opportunity to act as a team leader and provide training or coaching to junior colleagues within CDM.

Accountabilities:

As an Associate Director Project Data Manager, you'll provide CDM leadership for assigned projects, indications and/or studies. You'll take global accountability and serve as the second line of contact at the project level. Your responsibilities will include strategic planning and delivery of CDM deliverables at project level, management and oversight of vendor contracts, resourcing and budget management, and oversight of vendor performance for assigned projects and studies. You'll also be responsible for proactive risk management and issue resolution/escalation connected to Clinical Data Management improvement or technology.

Essential Skills/Experience:

  • University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree.

  • Ability to successfully manage simultaneous trials and meet deadlines.

  • Significant Clinical Data Management experience, preferable both from CRO and Pharma industry in more than one therapeutic area.

  • Excellent understanding of clinical trials methodology, GCP, GDMP and medical terminology.

  • Comprehensive knowledge of clinical standards, e.g. SDTM or CDASH.

  • High attention to detail and a strong analytical mind-set.

  • Excellent interpersonal skills and proven ability to operate effectively in a global environment.

  • Good written and verbal communication skills, negotiation, collaboration, conflict management and interpersonal skills.

  • Cultural awareness.

  • Experience of CRO and vendor management.

  • Experience as a lead of a large Phase III trial or multiple smaller trials.

  • Knowledge of SQL, 4GL, VBA or R software.

  • Experience of managing teams.

  • Experience with Regulatory Inspections.

  • Project Management training.

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 we need 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

At AstraZeneca's Oncology R&D department, we are a science-based, leading and decisive Oncology enterprise united in our vision to eliminate cancer as a cause of death. We push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what's next. We foster a mindset of courage, where everyone is empowered to step up, innovate and work at pace. We lead through true collaboration, building collective wisdom by giving everyone a chance to input. It's science with an impact-making a difference for patients and people around the world.

Ready to make a difference? Apply today to join our mission to eliminate cancer as a cause of death!

Date Posted

01-Jul-2024

Closing Date

15-Jul-2024

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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Tags: Data management GCP Pharma Pipelines R R&D SQL

Perks/benefits: Career development Flex hours Home office stipend

Region: Europe
Country: Poland

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