Digital Health Technologies - Sr Specialist (PM)
HybridArg, Marrakesh-Safi, Kingdom of Morocco
Job Summary
Execute COA systems development processes from kickoff to go-live, managing timelines, change control, and database lock activities. Define and enforce COA systems standards, conduct peer reviews of documentation, and monitor vendor performance through root cause analysis and corrective actions. Lead project planning, risk mitigation, and communication for assigned protocols while resolving issues between vendors and the Clinical Trial Team. Provide training support, mentor new staff, and lead continuous improvement initiatives. Serve as the subject matter expert for COA systems, escalating risks and liaising with internal and external stakeholders.
Required Qualifications
- B.A. or B.S. degree, preferably in life sciences, computer science, engineering or related discipline
- 6 years' experience in Clinical Data Management
- at least 4 years' of COA working experience
- Demonstrate knowledge of COA systems development processes
- Knowledge of the clinical development process, preferably through submission
- thorough knowledge of clinical data management
- Effective written and verbal communication skills
- Ability independently perform and manage multiple tasks at one time and meet deadlines in a complex environment working both internal or external to the Company
- Adaptability
- Clinical Data Management
- Clinical Research
- Communication
- Data Analysis
- Data Quality Assurance
- Data Reporting
- Data Review
- Data Validation
- Good Clinical Practice (GCP)
- Identifying Risks
- Medical Terminology
- Peer Reviewing
- Process Improvement Projects
- Product Risk Management
- Project Coordination
- Project Development
- Project Management
- Project Planning
- Projects Design
- Risk Management
- Standards Development
- Teamwork
- Vendor Management
- Vendor Risk Management
Desired Qualifications
- degree, preferably in life sciences, computer science, engineering or related discipline
- clinical development process, preferably through submission
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