Senior Clinical Data Manager I

Job Title - Senior Clinical Data Manager I

Career Level - D

Introduction to role

Are you ready to take your expertise in Clinical Data Management to the next levelAs a Senior Clinical Data Manager I, you will assist with coordinating CDM deliverables on assigned clinical studies, becoming an expert on CDM processes, standards, and technology. You will collaborate with DM vendors and liaise with various departments to ensure each study runs smoothly. Your role will be crucial in maintaining the integrity of the clinical database for relevant studies, working under the direction of an experienced Study Data Manager.

Accountabilities

Demonstrate leadership and operational knowledge in planning and delivering CDM deliverables at a study level.
Provide study status reporting to relevant clinical study team members.
Collaborate with Data Management Vendor/Study Data Manager regarding upcoming deliverables and milestone achievements.
Oversee data quality, documentation quality, and types of deliverables and milestones.
Assist with coordination in CDM deliverables on assigned projects.
Identify risks and collaborate with the Study Data Manager to mitigate them.
Understand therapeutic area, indication, or program-specific data capture standards and AZ standards.
Provide input into CDM-related activities associated with regulatory inspections/audits for assigned studies.
Contribute to the selection and use of software systems, devices, and vendors.
Ensure compliance with Trial Master File requirements relating to DM Vendor.
Drive adherence to AZ CDM standards and processes for data quality and consistency.
Maintain awareness of external and internal models for continuous improvement related to CDM operating models.
Take on ad hoc activities consistent with current or past experience in support of CDM.
Mentor junior Clinical Data Management colleagues.
Perform CDM-related ad-hoc requests from Line Manager.

Essential Skills/Experience

University or college degree in life sciences, pharmacy, nursing, or equivalent relevant degree.
End-to-end knowledge of Clinical Data Management and experience in the Biotech/Pharma/CRO industry.
Current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements.
Experience with clinical databases, different clinical data management systems, and electronic data capture (EDC).
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 deadlines.
Excellent written and verbal communication skills.
Ability to work in a global team environment.
Excellent organizational and analytical skills with high attention to detail.

Desirable Skills/Experience

Knowledge of clinical and pharmaceutical drug development processes.
Knowledge of database structures, programming languages, data standards (CDISC), and practices as they apply to CRF design, database development, data handling, and reporting.
Understanding of clinical data system design/development/validation and system interoperability.
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 medicines. In-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 push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs. We foster a mindset of courage where everyone is empowered to innovate and work at pace. Our collaborative environment allows us to build collective wisdom by giving everyone a chance to contribute.

Ready to make a differenceApply now!

Date Posted

Closing Date

AstraZeneca 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.