Senior Manager, Clinical Data Management 1181665
Job Scope & Purpose:
Our client is a clinical-stage pharma company focused on treating liver disease. They seek a talented CDM to be responsible for establishing and managing study data management activities through management/oversight of CRO partners performing data management activities across multiple clinical programs and therapeutic indications.
Primary Job Responsibilities:
- Oversee the establishment and maintenance of Data Management plans and study-specific data quality related documents across all data systems (e.g. EDC, IXRS, lab, eCOA, etc.)
- CRF Development and EDC validation including edit specification development and validation and User Acceptance Testing across all data systems
- Serves as the DM focal point on assigned studies for all local interfaces and preserves a fluent workflow with the other interfacing departments and local procedures and processes
- Provide oversight of external partners (e.g. CDM CROs, central laboratories, ECG core labs, dictionary coding service providers, etc.) to ensure consistency and quality are maintained across projects
- Manage the team data review and ensure all data issues are resolved per expectations for the delivery of clinical trial databases of the highest quality.
- Provide oversight of data transfer and/or data integration agreements across external data sources.
- Ensure that clinical data management activities for clinical trials and regulatory submission projects are completed on time and with excellent quality;
- Ensure that CDM study files are organized and accessible during study conduct, and that archives are completed after study closeout.
- Author and review department SOPs, as needed
- Mentor junior department team members, as needed
Primary Job Responsibilities:
- Bachelor's degree in a scientific, medical or related field; at least 7 years of Lead clinical data management experience, in pharma/biotech
- Thorough understanding of clinical trials process and regulatory requirements
- Thorough understanding of core CDM processes and procedures generally adopted as best practices within the industry, including knowledge of CDM processes with safety laboratory data management and dictionary coding for adverse events and medications
- Fully adept at the mechanics of conducting all phases of clinical trial data management within electronic data capture databases from study start up to study close out
- Familiar with the regulations that govern CDM activities
- Excellent organizational skills and able to adapt to multiple priorities in a fluid environment
- Excellent verbal and written communication skills
- Excellent skills in validating EDC databases and performing data review;
- Demonstrated leadership ability and project management skills
- Experience managing CROs in data management-related activities
- Ability to use PC and widely used software packages, e.g., Excel, MS Word, SAS programming
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