Associate Director Project Data Manager

2 weeks ago

Mississauga, Canada AstraZeneca Full time

Job Title: Associate Director Project Data Manager

Career Level - E

Introduction to Role:

Join us as an Associate Director Project Data Manager in our Oncology R&D department. In this role, you will be responsible for the oversight of the Clinical Data Management (CDM) delivery of high-quality data via external partners or internally run studies for one or more assigned projects or an indication. You will also act as an expert on Clinical Data Management (CDM) projects and technology outside of CDM program support. This is a fantastic opportunity to be empowered to act fast on smart risks and keep ahead in the fast-paced Oncology field.

Accountabilities:

As an Associate Director Project Data Manager, you will provide CDM leadership for assigned projects, indications and/or studies dependent on size and scale of the project. You will 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 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.

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 mission to eliminate cancer as a cause of death. As part of our Oncology R&D team, you will be at the forefront of applying science to studies and using innovative approaches to create new possibilities. We foster a mentality of courage, where everyone is empowered to step up, innovate and work at pace. We lead through true teamwork, 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 your mark? Apply now

Date Posted

31-May-2024

Closing Date

20-Jun-2024

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