Sr Clinical Project Manager/Clinical Project Manager - Gaithersburg, MD | Biospace
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Sr Clinical Project Manager/Clinical Project Manager

MedImmune, LLC

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Location:
Gaithersburg, MD
Posted Date:
3/27/2017
Position Type:
Full time
Job Code:
R-003647
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

                             
                                       Location:Gaithersburg, Maryland, United States
Cambridge, England, United Kingdom
Job reference: R-003647

Posted date: Mar. 02, 2017

                                                     
                           


 

   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 Sr Clinical Project Manager (grade 4)/Clinical Project Manager (grade 3) in Gaithersburg, MD, or Cambridge, UK, 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 Sr Clinical Project Manager / Clinical Project Manager, you will plan and manage overall clinical operations for assigned clinical trials)/programs including timelines, budgets, resources, investigational sites, vendors and key project deliverables in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines and in alignment with Therapeutic Area (TA) strategies and goals. You will provide matrix management of functional area representatives to cross-functional clinical trial teams (CTTs). You will attend and support the Clinical Sub- Team (CST).  

   Additional responsibilities include the following:  

       
  •      Manage selection of study vendors for assigned studies    
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  •      Manage the vendor(s) throughout the life of assigned clinical trial(s)    
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  •      Select investigational sites with input from Clinical Development and vendors    
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  •      Review and refine Clinical Operations Plans including study monitoring and other plans    
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  •      Oversee investigative sites' adherence to pertinent regulations through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel & CRAs    
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  •      Lead ongoing review of data to ensure quality and consistency    
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  •      Plan and conduct investigator meetings and ad boards, etc.    
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  •      Oversee the submission of trial-related and essential documents to the Trial Master File    
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  •      Identify and provide solutions to clinical trial issues or risks    
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  •      Provide input into non project related activities and development of procedures as requested    
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  •      Mentor staff and serves as a resource for new employees    
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  •      Provide or facilitate training to clinical study teams on protocol specific topics    
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  •      Participate as appropriate in internal and external audits    
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Requirements

   Essential Requirements  

   For Clinical Project Manager:  

 
       
  •      University degree, preferably in a biologic/scientific discipline    
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  •      Minimum of 5 years progressive experience in clinical operations including project coordination, site management and monitoring or equivalent and at least 3 years of project management experience or equivalent.    
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   For Sr Clinical Project Manager:  

 
       
  •      University degree, preferably in a biologic/scientific discipline    
  •    
  •      Minimum of 10 years progressive experience in clinical operations including 5 years of clinical project management or equivalent.    
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   Desirable Requirements    
       
  •      Oncology experience Phase I or II    
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  •      Thorough understanding of country level regulations, ICH and GCP guidelines    
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  •      Thorough understanding of cross-functional clinical processes including data management,    
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  •      biostatistics, medical writing, drug safety, and regulatory affairs    
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  •      Ability to lead across-functional team in a matrix environment    
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  •      Strong interpersonal and negotiation skills    
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  •      Strong verbal and written communications and presentation skills    
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  •      Proven complex problem solving and decision making skills    
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  •      Strong leadership, communication, management and organizational skills, conflict resolution, and    
  •    
  •      team building skills    
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  •      Strong line management experience    
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  •      Ability and willingness to trave1 25% of the time (internationally and domestically)    
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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.  

   *LI-MEDI