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CDM Business Operations Senior Analyst - 8583

Fladger Associates • Gaithersburg, MD, United States • 2d ago

Responsibilities:

Excellent employment opportunity for a CDM Business Operations Senior Analyst in the Gaithersburg, MD area.
Leads and/or participates in cross-functional CDM/Biometrics initiatives supporting Clinical Data Management processes and activities as assigned such as, but not limited to SOP management, internal metrics management, external vendor KPI tracking, and vendor and staff training,
Monitors, administers, and assesses quality, performance KPIs, and consistency within CDM that are aligned with company strategies and standards across Biometrics and Clinical to ensure delivery excellence.
Liaises with external departments such as Quality Compliance, Quality Assurance, Regulatory, Procurement, IT, Alliance Management, etc. concerning resolution of operational and scheduling/timeline issues in alignment with supervisor.
Participates in the oversight of all CDM based CAPA assessments and responses; assists CDM project leaders in the execution of any associated actions.
Collaborates with peers to assess process and design for CDM, eClinical Applications & Standards, Clinical Programming and Data Reporting, and Clinical Coding functions.
May facilitate and/or represent CDM during activities associated with regulatory inspections/audits.
Monitors industry developments within CDM space for consideration, planning and implementation.
Leads and/or coordinates training programs (technical and professional skills) of new hires, existing staff, new SOPs, and function advancements to instill consistency and currency of staff.
Develops and integrates clinical project standards and processes based on industry best practices
Delivers change management for documentation and training of standards, process and technology while escalating valid change requests to the Standards Committee
Provides CDM process expertise for Global Clinical Development Initiatives (Clinical, Regulatory and Drug Safety)
Interacts with external vendors and customers on transactional engagements in communication and problem solving.

Experience:

Minimum of a BS in life sciences degree and/or equivalent experience
Minimum of 5 years of Study Data Manager experience in the Biotech/Pharma/CRO industry
Experience as a project manager of special initiatives supporting CDM activities.
Experience in CDM process development
Strong problem-solving skills with CDM process and experience on computer systems for Data Management.
Strong understanding of clinical trial methodology, GCP, ICH and medical terminology
Experience with major EDC platforms such as Medidata Rave

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