Associate Director - Oncology - Data Management - (Gaithersburg, MD) - Gaithersburg, MD | Biospace
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Associate Director - Oncology - Data Management - (Gaithersburg, MD)

MedImmune, LLC

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Location:
Gaithersburg, MD
Posted Date:
6/27/2017
Position Type:
Full time
Job Code:
R-006274
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

                             
                                       Location:Gaithersburg, Maryland, United States
Job reference: R-006274

Posted date: May. 03, 2017

                                                     
                           


 

   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 an Associate Director, Clinical Data Management – Oncology 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 Associate Director, Clinical Data Management – Oncology, you will be providing therapeutic area leadership and functional area expertise in the strategic planning and delivery of Clinical Data Management (CDM) deliverables. You will oversee internal and external CDM staff, while ensuring compliance to MedImmune global and project standards. Also, representing the CDM function on all levels and can act as designee of the CDM Head.  

Requirements

   Essential Requirements  

 
       
  •      Education: Minimum of a BS in life sciences degree and/or equivalent experience    
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  •      Minimum of 10 years of Data Management experience in the Biotech/Pharma/CRO industry    
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  •      At least 5 years of line management and project team leadership experience    
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  •      Strong technical and problem solving skills with experience on computer systems for Data Management    
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  •      Excellent understanding of clinical trial methodology, GCP, ICH and medical terminology    
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   Desirable Requirements  

 
       
  •      Demonstrated leadership (including management of business process outsourcing/contract research organization models) and people management skills    
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  •      Ability to work independently, under pressure meeting tight deadlines, demonstrating high level of initiative and flexibility.    
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  •      Excellent organizational and analytical skills    
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  •      High attention to detail and accuracy    
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  •      Ability to negotiate and influence others across functional areas    
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  •      Proven problem and conflict solving skills    
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  •      Demonstrated knowledge of clinical and pharmaceutical drug development process    
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  •      Demonstrated current understanding of GCP and regulatory requirements as they relate to data management systems and activities    
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  •      Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP)    
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  •      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    
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  •      Experience of clinical databases, clinical data management systems and electronic data capture (EDC)    
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  •      Knowledge and understanding of clinical database design / study build / data validation and system interoperability    
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  •      Competent with project management skills    
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  •      Excellent communication and interpersonal skills    
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  •      Ability to work independently and act as role model/mentor subordinate staff    
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  •      Demonstrated ability to work effectively with internal groups and external partners    
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  •      Ability to work in a global team environment    
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  •      Ability to interact effectively with all levels of management    
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   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.  

   ~bsp  

 

   *LI-MEDI