Senior Clinical Data Manager I
Senior Clinical Data Manager I
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Job Description
Job Title: Senior Clinical Data Manager I
Career Level: D
Introduction to role:
Are you ready to dive into the world of Clinical Data Management and make a significant impact on global health As a Senior Clinical Data Manager I youll coordinate CDM deliverables for assigned clinical studies ensuring they align with our high standards and innovative processes. Youll collaborate with diverse teams and vendors maintaining the integrity of clinical databases and supporting the Global Study Team for less complex studies. This role offers the chance to be at the forefront of data management in the biotech and pharmaceutical industry working under the guidance of experienced Study Data Managers.
Accountabilities:
In this dynamic role youll provide operational support at the study level managing activities from start-up to closeout phases. Your leadership will be crucial in planning and delivering CDM deliverables reporting study status and collaborating with vendors on milestones. Youll oversee data quality documentation and compliance with Trial Master File requirements. With a keen understanding of therapeutic areas and AZ standards youll identify risks and work with Study Data Managers to mitigate them. Your input will be valuable in regulatory inspections and audits as well as in software system selection. Youll drive adherence to CDM standards flagging opportunities for continuous improvement and mentor junior colleagues while handling ad-hoc requests.
Essential Skills/Experience:
This candidate should have Data Management experience with an expertise in External data vendor data types and Process.
The role demands the associate to lead Third Party Activities of 2-3 studies and provide Subject Matter Expertise. Activities include but are not limited to creating Transfer Agreements specifications and other critical TPV related documents highlight timely risks and provide mitigations. It is mandatory for the role to ensure that high quality and meet timelines as expected for the projects.
Support audit and inspections.
Have an understanding of Data Standards and cleaning checks.
Successful performance in this role requires leadership Partner management managing priorities and strong communication skills.
- University or college degree in life sciences or related subject pharmacy nursing or equivalent relevant degree.
- End-to-end 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.
- Demonstrated experience of clinical databases different clinical data management systems and electronic data capture (EDC).
- Demonstrate understanding and experience in leading studies query management process and reconciliation activities.
- Ability to work flexibly on simultaneous projects and proactively manage time to meet own deadlines.
- Excellent written and verbal communication skills.
- Ability to work in a global team environment.
- Excellent organizational and analytical skills and high attention to detail.
Desirable Skills/Experience:
- Demonstrated knowledge of clinical and pharmaceutical drug development process.
- Knowledge 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.
- Demonstrated ability to work effectively with external partners.
- Knowledge of SQL 4GL VBA or R Programming.
When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 driven by our passion for science and innovation. Our commitment to exploring new frontiers allows us to tackle some of the worlds most complex diseases. By fusing data and technology with scientific breakthroughs we are shaping the future of healthcare. Our inclusive environment encourages collaboration across academia biotechs and industry creating swift impacts on disease treatment. With a focus on lifelong learning and growth AstraZeneca offers a place where you can build a meaningful career while making a difference in patients lives worldwide.
Ready to make your mark in the world of Clinical Data Management Apply now to join our team!
Date Posted
11-Aug-2025Closing Date
16-Aug-2025AstraZeneca 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.
Required Experience:
Manager
Employment Type
Full-Time
