Manager, Clinical Data Manager – Study Lead

Data ScientistData ScientistFull TimeRemoteSeniorTeam 10,001+Since 1988H1B SponsorCompany SiteLinkedIn

Location

New York

Posted

1 day ago

Salary

$114.8K - $187.4K / year

Seniority

Senior

Bachelor Degree7 yrs expEnglish

Job Description

Manager, Clinical Data Manager – Study Lead

Regeneron

• Serve as the DM study lead and the primary point of contact for clinical study teams and external partners • Oversee all DM activities across all stages of the trial from study start-up through archiving • Provide a high level of expertise in data management to support clinical studies • Provide clear verbal or written information and hands-on support to project team members and to CROs related to eCRF and database design, data quality, and reporting of database / data quality status • Oversee the implementation and execution of procedures for data quality review and data acceptance prior to data analyses and/or database lock • Manage data transfers with CROs and third-party data sources, SAE/AE reconciliation and MedDRA/WHO-DD coding • Support the transfer, locking, and archiving of study databases • Manage scheduling and time constrains across multiple projects • Prepare recommendations for new or improved processes for data management and data flow • Document DM sponsor oversight activities from protocol review through study close-out

Job Requirements

  • Bachelor Degree or equivalent experience in Mathematics, Science or a related field
  • at least 7 or more years of clinical data management experience in biotechnology, pharmaceutical or health related industry
  • Perform quality review and inspection readiness tasks to meet quarterly Inspection Readiness Review (IRR) compliance
  • Follow through on gaps until resolution, escalating as necessary
  • Lead/oversee all data management deliverables for assigned studies

Benefits

  • annual bonuses or other incentive plans
  • equity awards
  • pension or retirement benefits
  • 401(k) company match
  • health and wellness programs
  • fitness centers
  • insurance benefits (e.g. medical, dental, vision, life and disability)
  • paid time off
  • family support benefits

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