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Associate Director

4 months ago


Mississauga, Canada AstraZeneca Full time

Job Title: Associate Director Project Data Manager"

Career Level - E

Introduction to role

Are you ready to take on a leadership role in Clinical Data Management (CDM)? We are seeking an Associate Director Project Data Manager to oversee the delivery of high-quality data for one or more assigned projects. This role requires an expert in CDM projects and technology, with a keen eye for trends and changes in external CDM approaches. You will also have the opportunity to act as a team leader, providing training and coaching to junior colleagues. Join us and be empowered to act fast on smart risks in the fast-paced Oncology field

Accountabilities

As an Associate Director Project Data Manager, you will provide CDM leadership for assigned projects, taking global accountability and serving as the second line of contact at the project level. You will demonstrate leadership and operational expertise in the strategic planning and delivery of CDM deliverables at project level. This includes 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/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, SDTM or CDASH.

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

Demonstrates a comprehensive knowledge of database structures and of capturing and storing clinical information as they apply to CRF design, database development, data handling and reporting.

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.

Desirable

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 push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. We are a science-based, leading and decisive Oncology enterprise united in our vision to eliminate cancer as a cause of death. 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 and join our mission to eliminate cancer as a cause of death

Date Posted

31-May-2024

Closing Date

20-Jun-2024