Observational Post-Approval Clinical Study Manager (Remote, Multiple Sclerosis) (s469)

  • Contract Duration: 10+ Months, Extendable, REMOTE
  • Clinical
  • Cambridge, MA (Remote)

Website Lenox Executive Search

Job description

Lenox Executive Search is seeking an experienced post-approval study manager to support the Pharmacoepidemiology Group within the Specialty Care department. Working closely with lead pharmacoepidemiologists, the study manager is responsible for supporting the operational delivery of the following three observational post-authorization safety studies ensuring regulatory-grade quality and compliance:

1. A non-interventional post-authorization safety study to investigate drug utilization and safety monitoring patterns for Lemtrada (alemtuzumab)
2. A non-interventional post-authorization safety study to investigate the risk of mortality in multiple sclerosis patients treated with alemtuzumab (Lemtrada) relative to comparable multiple sclerosis patients using other disease modifying therapies: a cohort study
3. A registry-based post-authorization safety study to evaluate the long-term safety of dupilumab in children aged from 6 months to less than 6 years with moderate-to-severe atopic dermatitis

The exact responsibilities will differ depending on the operational complexity of the studies, so a high degree of flexibility is required.

Current studies are related to Multiple Sclerosis (however specific experience in MS is not required)

RESPONSIBILITIES of the Observational Post-Approval Study Manager:
• Contribute to the development of study documents as appropriate as well as any updates/amendments, ensuring template and version compliance.
• Lead the preparation of any agreements related to the study, confidentiality agreements, any applications or other applicable country documents.
• Provide input to data management documents (e.g. Case Report Form, Data Validation Specifications), and interface with data management representatives and clinical centers to facilitate the delivery of study data.
• Provide oversight of data delivery.
Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study results and meeting Regulatory milestones to the necessary quality, timelines or budget.
• Min Education BS Degree

REQUIREMENTS of the Observational Post-Approval Study Manager:
•       3-4 years of related Clinical Management experience
•       Experience with preparation of any agreements related to the study, confidentiality agreements, any applications or other applicable country documents.
•       Experience with studies moving forward to a regulatory filing
•       Managing clinical trials from a sponsor standpoint
•       Act as the liaison investigator academic centers in UK
•       experience with EU regulatory standards, EMA (European Medicine Agency) – filings, post-marketing commitments
•       Regulatory-mandated studies
•       Experience managing large epidemiological or complex observational studies is a plus, though not a requirement

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