Clinical Data Manager I

Job Title: Clinical Data Manager I

Career Level - C

Introduction to role

Are you ready to make a difference in the world of clinical data management? As a Clinical Data Manager I, you will support the delivery of high-quality data for assigned clinical studies or indications managed by various Data Management Sourcing models. Under the supervision of an experienced Data Management Lead, you will handle data management tasks of simple to medium complexity and interact with global study team members, including CRAs and External Data Suppliers.

Accountabilities

Assist with Study level CDM administrative support based on the relevant model and DM Vendor. This may include but is not limited to activities related to the study start up, conduct and closeout phases. (i.e., documentation review and/or creation, User Access Testing, query management, data cleaning and reviews, third party data reconciliation in accordance with the project study model, KPIs and timelines.)
• Day to day responsibilities may include but are not limited to:
  o Study status reporting to the relevant clinical study team members, (e.g., provide data to clinical teams for performing medical and clinical reviews, coordination of instream data review, lab data review, etc.)
  o Collaboration with Data Management Vendor regarding upcoming deliverables and milestone achievements (i.e., snapshots, interim, and migrations).
  o Oversight of the data quality, documentation quality, and types of these deliverables and milestones.
• Support DM Delivery Leads to maintain CDM specified systems and types of deliverables, milestone achievements, risks and mitigations and data transfer agreements, and other study administrative needs.
• Support DM Delivery Leads in oversight of Trial Master File compliance for audit readiness. May include activities related to study expected document Lists and quality compliance checks.
• Support DM Delivery Leads in User Acceptance Testing of internal and external electronic Data Capture systems as required.
• Provides support to the resolution of issues related to Clinical Data Management deliverables and inputting ideas to help resolve issues and contribute to continuous improvement.
• Performs any CDM related ad-hoc requests as requested by the DM Leads.

Essential Skills/Experience

- University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree
- Languages: Fluent English (oral and written)
- Attention to detail to ensure quality
- Good verbal and written skills
- Ability to work flexibly on simultaneous projects and proactively manage time to meet own deadlines.
- Strong interpersonal skills and proven ability to communicate effectively in a global environment.

Desirable Skills/Experience

- Basic understanding of clinical trials methodology, Clinical Data Management, GCP and medical terminology

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 driven by a shared purpose to push the boundaries of science and transform the lives of patients living with cancer. Our pioneering spirit and commitment to innovation allow us to work on groundbreaking drug modalities that go beyond traditional molecules. By joining our team, you will be at the forefront of biotechnology advancements, collaborating with top experts across the globe to tackle the toughest medical challenges. We foster a culture of courage and curiosity, empowering our employees to take smart risks and learn from failures. Together, we are dedicated to making a meaningful difference in the lives of patients.

Ready to make an impact? Apply now and join us on this exciting journey!

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.