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Director - Clinical Data Management

4 months ago

Mississauga, Canada AstraZeneca Full time

Job Title: Director - Clinical Data Management

Career Level - F

Introduction to role:

Join us at AstraZeneca as a Director of Clinical Data Management, where you 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. You will be a key player in our Oncology R&D team, ensuring CDM quality, managing external partners, and delivering against metrics for the CDM Function. This role is an opportunity to influence decision making with relevant partnering teams and drive a culture of delivering to established milestones with the highest degree of customer satisfaction.

Accountabilities:

As a Director of Clinical Data Management, you will provide leadership for assigned projects, taking global accountability and serving as the second line of contact at the project level. You will demonstrate operational expertise in strategic planning and delivery of CDM deliverables at project level. Your role will involve management and oversight of vendor contracts, resourcing, budget management, and vendor performance for assigned projects and studies. You will also be responsible for proactive risk management and issue resolution 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, 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, we are on a journey to create the future of medicine. We work towards our ambition to become a healthcare provider beyond medicines. We use technologies to better understand diseases, develop new medicines and support patients with all aspects of their disease. We are digitally enabling the entire Research & Development cycle: improving clinical trials and data collection, using machine learning and visual analytics for informed decision-making, integrating data to improve patient outcomes, and gaining insights to inform the next generation of products. If you thrive on adapting your skills and learning from failures, then this is the place for you.

Ready to make a difference? Apply today

Date Posted

31-May-2024

Closing Date

06-Jun-2024