is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Clinical Data Management Project Lead (DMPL)/Sr. Data Management Project Lead
in Gaithersburg, MD
, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.Main Duties and Responsibilities
As the DMPL/Sr. DMPL, you will provide leadership and functional area expertise in the strategic planning and delivery of Clinical Data Management (CDM) deliverables. Oversees the Data Management Center (DMC) by managing prioritizing and ensuring compliance to MedImmune global and project standards. Forecasts DMC workload based on corporate pipeline and priorities. You will manage vendor contracts and DMC budget. The DMPL will be assigned to one or more therapeutic areas dependent on size and scale of the project DM deliverables and will take global accountability.Essential Requirements
- Minimum of a BS in life sciences degree and/or equivalent experience
- Minimum of 8 years of Data Management experience in the Biotech/Pharma/CRO industry
Next Steps - Apply today!
- Demonstrated knowledge of clinical and pharmaceutical drug development process
- Demonstrated current understanding of GCP and regulatory requirements as they relate to data management systems and activities
- Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP)
- State of the art understanding of database structures, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting
- Experience of clinical databases, different clinical data management systems and electronic data capture (EDC)
- Demonstrated understanding of clinical data system design / development / validation and system interoperability.
- Demonstrated leadership (including in an outsourced environment)
- Demonstrated project management skills
- Strong communication and interpersonal skills
- Excellent organizational and analytical skills
- Ability to work independently
- Demonstrated ability to work effectively with external partners
- Ability to negotiate and influence others across functional areas
- Excellent written and verbal communication skills
- Effective problem and conflict solving skills
- Ability to work in a global team environment
- Ability to interact effectively with all levels of management
- High attention to detail and accuracy
- Extensive knowledge of Medidata Rave EDC Lab Module including definitions and maintenance of labs, lab parameters and associated reference ranges.
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
A little about us:
MedImmune is the global biologics research and development arm of AstraZeneca