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Senior Manager, Clinical Data Management

Company: Alexion Pharma Spain S.L.
Location: New Haven
Posted on: February 22, 2021

Job Description:

Senior Manager, Clinical Data Management Req ID: 20300
Job Category: Biostatistics, Clinical Data Management, & Programming Attention: If you are a current Alexion employee, please apply via
Alexion's internal Life & Career portal . Note that you will need to be connected to the VPN if you are applying away from the office. Alexion does not contact candidates via instant messaging or chat tools. At no time will we ask candidates for fees associated with obtaining software, nor do we provide employees with a cashier's check to purchase new equipment. If you are contacted in this manner, please be aware that it is fraudulent, and please do not provide any information or money to these individuals. Applicants should only apply through this Alexion website. Any fraudulent activity should be reported to GSOC@alexion.com Share this job This position can be based from any of the following Alexion locations; San Francisco, CA, Boston, MA, New Haven, CT, or Blue Bell, PA and may require up to 10% travel. Po s iti o n Summ a r y T h e S e n i o r M anag er o f Global Cli n i c a l D a ta M anag e m e n t (G C D M) i s r es p o n s ibl e f o r dir e c t l y an d ind e p e nd e n t l y m anagin g internal staff and vendor relationships to ensure that budg ets an d t i m e lin e s are developed by utilizing proactive strategies based on metrics and forecasts in order to deliver high quality data on time and within budget scope. T h is p o s i t i o n i s r es p o n s ibl e f o r pr e s e r v in g d a ta in te gri ty and delivering accurate data for all data deliveries including, but not limited to, r e gula t o r y s u b m is s i o n s an d publi c a t i o n s. This position reports to Director level GCDM.

  • Identify and implement solutions to data management issues and concerns, including proactive prevention strategies based on metrics and forecasts.
  • Provide leadership and functional partnering with internal and external project teams to provide data management status updates including cycle times and productivity metrics.
  • Participate as a stakeholder in current and developing data t ec h n o l o gi es and / o r s ys t e m s.
  • Assist in the formulation of short-term and long-term strategies to improve project data management efficiencies.
  • Provide leadership in the development of standard practices and work instructions related to the general data management functions including, but not limited to, the following:
    • C e n t raliz ed Me d D RA an d W H O - D D di ct i o nar y c o din g an d v e r s i o ning
    • E l ect r o ni c da ta c ap t ur e w i t h Me dida t a R AV E and utilization of Medidata Suite products (ePRO, RTSM, Safety Gateway, etc.)
    • L ab o ra t o r y da ta st andardiza t i o n an d c o ll e ct i o n
    • Standard Case Report Form Completion Guidelines
    • Standard Data Management Plans
    • Data Import/Export Agreements and associated data specifications
    • Participate in the development of standard practices and work instructions related to the specific data management functions including, but not limited to, the following:
      • St andar d C D AS H c as e r e p o r t f o r m librar y and associated edit checks
      • St andar d e di t s p e c if i c a t i o n s libra r y
      • Data Visualization tool development and data mapping; enhanced data cleaning and querying via use of data integration platforms
      • Provide documented processes and oversee t h e data s u b m i ss i o n p r o c ess w i t hi n t h e G C DM d e par t m e n t to p r ov id e s ub m i ss i o n- r e ad y d a t a se t s an d associated d o c u m e n t a t i o n for specific studies .
      • E n s u r e all studies are prepared for audit inspections including documentation for database builds, data review, and data extract for all points of data and associated data flow diagrams.
      • Develop request for proposals (RFPs) for external GCDM vendor contracts.
      • M anag e G C DM p e r s o nn e l , p ri o ri t i e s , an d w o r k l o a d o n t h e pr e para t i o n , v alida t i o n , pr o cess ing , r e v i e w ing , qu e r y ing , di ct i o nar y c o ding , an d m ain t e n a n ce o f c lini c a l da t a o n indi v idua l c lini c al t rial s an d in preparation for r e gula t o r y s ub m i ss i o n s and publications.
      • Supervise, mentor and evaluate performance of staff to ensure career development, interpersonal skills, and achievement of competency standards. Qu a lif i ca t i ons
        • Ex p e ri e n c e i n c li n i c a l d a ta m anag e m e n t for 10+ y e ar s. Ex p e ri e n c e i n m anagin g r e p o r ts for 5+ ye ar s.
        • Experience in vendor management of outsourced studies.
        • Po s sess m ana g e m e n t ex p e ri e n ce; t rainin g an d d e v e l o p m e n t o f p e r s o nn e l ; an d p r e para t i o n an d c o ndu ct in g p e r f o r m an ce r e v i e w s.
        • Po s sess a t h o r o ug h k n o w l e dg e o f m e di c a l t e r m i n o l o g y ; an d t h e c li n i c a l da ta m anag e m e n t a nd t h e c lini c a l t ria l pr o cess.
        • P r o f i c i e n t o n r e gula t o r y r e quir e m e n ts f o r da ta m ana g e m e n t an d t h e r e gula t o r y s ub m i ss i o n pr o cess.
        • P r o f i c i e n t o n t h e d es ig n a n d v ali d a t i o n o f da ta c o ll e ct i o n in st r u m e n t s ; t h e da ta c o ll ect i o n an d da ta r e v i ew pr o c es s ; an d d a ta st andardiza t i o n .
        • Experience with CDASH terminology and/or MedDRA and WhoDrug medical coding required.
        • Medidata Rave experience required.
        • Medidata Suite products (Safety Gateway, ePRO, RTSM) preferred.
        • P r o f i c i e n t o n e v alua t ing , t e st ing , an d m anagin g n e w d a ta st andard s, tec h n o l o g i e s, an d sy s t e m s.
        • P r o f i c i e n t o n d e v e l o pin g r e qu est f o r pr o p o s al s f o r ex t e rna l v e nd o r c o n t r a cts.
        • Ex p e ri e n c e i n s o l v in g c o m p l ex an d in c r e a s ingl y difficu l t pr o bl e m s, ind e p e nd e n t l y t a k in g t h e appr o pria te c o r r ect i v e a ct i o n , an d id e n t i f y an d i m pl e m e n t i m p r o ve m e n ts. Abl e to r e v i ew, in te rpr et an d e v alu a te c lini c a l da t a.
        • Po s sess e ff e ct i v e w ri t t en a n d v e rba l c om m uni c a t i o n s k ill s n ec e ss ar y t o in te r a ct w i th p e r s o nn el a t al l l e v e l s w i t hi n an d ex te rna l to t h e c o m pan y.
        • D e mo n s t ra te ini t ia t i v e, s o u n d j udg m e n t an d fl e x ibili t y ; p o ss e ss e f f ect i v e t i m e m a nag e m e n t an d o rganiza t i o na l sk ills ; an d b e abl e to w o r k und er d e ad l in es an d o n m ul t ipl e pr o j e c ts s i m ul t an e o u s l y.
        • Abl e to e ff e ct i v e l y c oo rdi n a te p e r s o nn e l , v e nd o r s, te a m s, an d p r o j e cts. Edu ca ti on
          • Re quir es a Ba c h e l o r 's d e gr ee i n a sc i e n t if i c dis c iplin e o r e qu i v al e n t. A M a ste r ' s d e gr ee i n a r e la ted s c i e n ce fi e l d i s pr e f e rr e d . *LIRM-1 Alexion participates in E-Verify process. To learn more, please click on attached document(s)

Keywords: Alexion Pharma Spain S.L., New Haven , Senior Manager, Clinical Data Management, Executive , New Haven, Connecticut

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