Penfield Search Partners
Contact: Linda Aronova – email@example.com
Job Description: An External Data Lead role is a Clinical Data Manager with expertise in the data collection of 3rd party data from various external providers (e.g., laboratories, eCOA providers, technology providers, etc.) performing testing or data collection services on behalf of company. The external data manager is also an expert in the integration of external data into the clinical trial database.
- Review and provide input to protocol and amendment development, provide input to trial design and protocols as it pertains to external data collection and integration
- Contributes to the standardization of data type specifications to ensure external data transfers to meet EDC requirements, ensures alignment of data transfer with CDASH and SDTM requirements, and with the trial analysis and reporting needs.
- Oversight/manage DM CRO for creation of data transfer specifications requirements. Ensure data collection requirements are aligned with external vendor capabilities and vendor data are compatible with the clinical database and SDTM requirements to support data integration, analysis, and reporting. Ensure vendor data is transferred in standard data formats. Manage issues related to reconciliation of external data.
- Provides review and set-up of vendor documentation performing testing or data collection services on behalf of company.
- Identifies and resolves external data issues throughout the life of the trial.
- Liaises with internal stakeholders (Biomarker Operations, Data Management, Data Analytics, Medical, Statistics, etc.) and external partners to ensure collaboration to meet company requirements and timelines.
- Bachelor’s degree in science or related area 3-5+ years of Clinical DM and External Data experience in biotech/pharma industry, hands-on experience in all aspects of clinical data management activities.
- Experience in oncology trials, understanding of the complex and interdependent relationships between protocol development, data collection and analysis and reporting in oncology trials.
- EDC technical proficiency and the ability to identify complex technical issues/data transfer issues and provide recommendations for solutions
- Experience with proficiency in the use of data management systems, strong knowledge of DM processes, tools, methodologies, documentation, and strong understanding of DM data collection strategy.
- Experience working with GCPs, SOPs, regulatory requirements, and good data management practices
- Experience with CDISC (SDTM); data collection requirements in oncology trials; and clinical data standards development and maintenance.
- Experience in project management.
- You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
- You bring rigor and excellence to all that you do. You are a fierce believer in our rooted in science approach to problem-solving
- You are a generous collaborator who can work in teams with diverse backgrounds
- You are determined to do and be your best and take pride in enabling the best work of others on the team
- You are not afraid to grapple with the unknown and be innovative
- You have experience working in a fast-growing, dynamic company (or a strong desire to)
- You work hard and are not afraid to have a little fun while you do so