Data Management Project Lead/Sr. Data Management Project Lead - (Gaithersburg, MD)

If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions - join us.
MedImmune 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 Data Management Project Lead (DMPL)/Sr. Data Management Project Lead (Sr. DMPL) 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 ResponsibilitiesAs 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 CRO or vendor partner by managing, prioritizing, and ensuring compliance to MedImmune global and project standards. Forecasts DMC workload based on corporate pipeline and priorities. Manages vendor contracts and DMC budget. The DM Project Leader will be assigned to one or more therapeutic areas dependent on size and scale of the project DM deliverables and will take global accountability.  You will serves as the expert in Clinical Data Management to provide oversight and advice to the clinical project team regarding the CDM activities and deliverables.  Manages and resolves issues related to DMC deliverables by developing solutions to complex problems to ensure consistency across organization.  Provides input to the CDM related activities associated with regulatory inspections/audits.  Provide CDM business expertise and consultancy in the selection and use of software systems and vendors.  Development and oversight of DM processes and standards and functional leadership.  Oversee quality and consistency with Medimmune strategies and standards across therapeutic areas.  Develops clinical project standards and processes based on industry best practices.  Works with study teams to understand and explain standards, while escalating valid change requests to the Standards Committee.  Assesses MedImmune CDM needs and areas of improvement and recommends changes to the operating model.  Provide strategic DM expertise to global Clinical Initiatives.  May be asked to take on a global standards role as a member of the Standards Committee.  Management and oversight of vendor contracts, resourcing and budgets.  Reviews, assesses and manages DMC delivery against KPIs and overall DMC performance.  Initiates contract process for the CDM vendor and provides study team with estimated costs.  Provides the DMC with MedImmune project planning information.  Scopes out budgets/costs associated with DMC activities as well as EDC vendor.  Manages DMC Service Order and Purchase Order process.  Ensures DMC billing is accurate and authorizes payment of invoices.  Provide high level expertise in the contract process for any CDM related activity (Sr. DMPL only).  People Management and development (Sr. DMPL only).  Selects, recruits, develops, manages, coaches, coordinates, and appraises the performance of direct and indirect reporting associates and ensures high quality performance management.  Builds and maintains strong partnerships with internal teams and external partners to ensure clinical data is of high quality, delivered on time, and within budget. .  Ensures optimum performance of group function. Recommends and implements techniques to improve productivity, increase efficiencies, reduce costs, and maintain state-of-the-art practices.
Essential Requirements
  • Minimum of 6 years of Data Management experience in the Biotech/Pharma/CRO industry
  • Minimum of 8 years of Data Management experience in the Biotech/Pharma/CRO industry
  • Minimum of a BS in life sciences degree and/or equivalent experience
Desirable Requirements
  • 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 and coach/ /mentor staff, as necessary
  • 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
Next Steps - Apply today!
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.

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