Associate Director

4 weeks ago

Bangalore, India AstraZeneca Full time

Job Title: Associate Director - Study Data Manager"

Career Level - E

Introduction to role:

Are you ready to take our leading Oncology pipeline to the next level? As an Associate Director - Study Data Manager, you will be responsible for coordinating the Clinical Data Management (CDM) deliverables on assigned clinical studies. You will be a part of our Global Study Team (GST) and the main point of contact for the Data Management (DM) vendor. This role is crucial in ensuring CDM deliverables follow standards and meet data quality. If you are passionate about making a difference in the field of Oncology, this could be the perfect opportunity for you

Accountabilities:

As an Associate Director - Study Data Manager, you will be responsible for coordinating the Clinical Data Management deliverables on assigned studies. You will demonstrate strong leadership, project management skills and operational knowledge in the planning and delivery of CDM results at a study level. You will also provide input into DM related activities associated with regulatory inspections/audits for assigned studies. Your role will also involve overseeing DM Vendor performance, reviewing, assessing and managing DM Vendor delivery against KPIs, budget and overall performance.

Essential Skills/Experience:

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

Solid knowledge of Clinical Data Management and experience in the Biotech/Pharma/CRO industry.

Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements.

Strong Project Management and Lead DM experience; Exhibits expertise in metrics analysis and reporting methodologies.

Proven ability to work effectively with external partners.

Demonstrated experience of clinical databases, different clinical data management systems and electronic data capture (EDC).

Demonstrate understanding and experience in query management process and reconciliation activities.

Good communication and interpersonal skills including effective problem solving.

Ability to work independently without close supervision.

Excellent written and verbal communication skills.

Ability to work in a global team environment.

Excellent organizational and analytical skills, sound decision making skills, and high attention to detail.

Demonstrated knowledge of clinical and pharmaceutical drug development process.

State of the art understanding of database structures, programming languages, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting.

Demonstrated understanding of clinical data system design / development / validation and system interoperability.

Demonstrates integrity, subtlety, mutual respect and the ability to manage/value diversity and cultural differences and promote efficiency through inspiration.

Experience within Sponsor organization and Regulatory inspections.

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.

Why AstraZeneca?

At AstraZeneca, we are united in our vision to eliminate cancer as a cause of death. We are pioneers in Oncology R&D, making ambitious moves that transform the way cancer is treated and truly improve patient outcomes. 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 an attitude 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. Our pipeline is a testament to our growth, both now and in the future. Our values are evidence of our commitment to Oncology and our people. By working with us, you get exposure to multidisciplinary learning and diverse perspectives.

Ready to make a difference? Apply now and join us in our mission to eliminate cancer as a cause of death

Date Posted

30-May-2024

Closing Date

03-Jun-2024

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