Manager, Clinical Data Management Study Lead - Warren Township
5 days ago
Job summary
The Manager Clinical Data Management provides oversight of lead Data Manager(s) on assigned clinical data management projects in multiple therapeutic areas to assure proper planning execution for data management results that meet Regeneron standards within timelines.Serves as primary DM contact for assigned therapeutic areas to interact with clinical counterparts for overall project planning issue resolution Projects allocates prioritizes DM resources within assigned therapeutic projects Supervises direct DM reports planning managing all relevant DM activities within assigned therapeutic areas timely quality results budget Mentor junior data managers skills advancement If required leads performs clinical data management tasks studies Supervises ensures databases developed validated ready transfer analysis according policies procedures SOPs work instructions compliance applicable regulations Reviews approves final archival project documentation including but limited CRF Completion Guidelines validation specifications work instructions assigned projects Designs modifies CRF This Role Might Be You If Supervises DM direct reports initiation approval building validation clinical databases subsequent changes clinical databases data validation activities Coordinates clinically project team issue resolution Contributes development Regeneron outsourcing strategies long-term relationships outsourcing partners objective ensuring data quality efficiencies through standardization Ensures adequate CROs vendors coordination all data functions Establishes goals expectations accountabilities direct reports Regularly reviews performance respect quality timeliness standards accordance Regeneron SOPs working procedures Responsible coaching handling training leading direct report To considered Bachelors degree mathematics Science related field along least years experience biotech pharmaceutical health industry Previous oncology ophthalmology experience plus managerial preferred Directed comfortable teams ability operate independently tight time line environment High creativity latitude attention detail required Knowledge all applicable regulations CFR GCP ICH Guidelines Strong communication leadership business development required Proficient appropriate EDC applications Microsoft Office applications Software proficiency CDMS Experience JMP SAS plus Does sound Apply take first step living Regeneron Way We have inclusive culture comprehensive benefits vary location In U.S. may include wellness programs medical dental vision life disability insurance fitness centers company match family support benefits equity awards annual bonuses paid time off paid leaves eligible employees levels For additional information benefit US please visit other countries specific speak recruiter.
Job description
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