CDM Business Operations Senior Analyst
Bethesda Metro Area, MD
The CDM Business Operations Senior Analyst is an experienced professional in a matrix role within Clinical Data Management, reporting to the Head of CDM Business Operations. This position has focus upon activities and objectives that measure the internal quality and performance metrics as well as the external vendor (CRO) KPIs. In addition, as part of continuous improvement this position is responsible for assessing quality gaps and CAPA submissions, identifying isolated events from systemic issues and delivering improved process mitigation strategies and trainings. As a broader corporate initiative this role supports CDM s TMF/eTMF processes, currency, and compliance tracking for audit readiness. The role manages and maintains initiatives and actions regarding quality standards, process development, resource training, and performance metrics.
Major Duties and Responsibilities:
o 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,
o Monitors, administers, and assesses quality, performance KPIs, and consistency within CDM that are aligned with strategies and standards across Biometrics and Clinical to ensure delivery excellence.
o 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.
o Participates in the oversight of all CDM based CAPA assessments and responses; assists CDM project leaders in the execution of any associated actions.
o Collaborates with peers to assess process and design for CDM, eClinical Applications & Standards, Clinical Programming and Data Reporting, and Clinical Coding functions.
o May facilitate and/or represent CDM during activities associated with regulatory inspections/audits.
o Monitors industry developments within CDM space for consideration, planning and implementation.
o 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.
o Develops and integrates clinical project standards and processes based on industry best practices
o Delivers change management for documentation and training of standards, process and technology while escalating valid change requests to the Standards Committee
o Provides CDM process expertise for Global Clinical Development Initiatives (Clinical, Regulatory and Drug Safety)
o Interacts with external vendors and customers on transactional engagements in communication and problem solving.
o Perform all other related duties as assigned.
Competent project management skills
Excellent communication and interpersonal skills
Knowledge of issues surrounding CDM activities related to clinical trials data
Ability to work independently, under pressure meeting tight deadlines, demonstrating high level of initiative and flexibility.
Excellent organizational and analytical skills
High attention to detail and accuracy
Proven problem and conflict solving skills
Demonstrated knowledge of clinical and pharmaceutical drug development process
Demonstrated understanding of Good Clinical Practices (GCP), Good Clinical Data Management Practices (GCDMP), and regulatory requirements as they relate to data management systems and activities
Experience with clinical databases, clinical data management systems and electronic data capture (EDC)
Demonstrated ability to work effectively with internal groups, external partners, and in a global team environment
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