Planet Pharma
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Manager, External Data Management II
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Planet Pharma 6 days ago Be among the first 25 applicants Job Description
Target Pay Rate: 70-80.71/hr
salary will be commensurate with experience The Manager External Data Management (Level 2) is responsible for end-to-end delivery of external data in client R&D, collaborating with Clinical and Medical teams, Functional Stakeholders (QCP, Clinical Biomarkers, etc.), Clinical Safety, CROs, and External Vendors. The role supports drug development processes and global submissions by providing expertise in Data Management, partnering with internal and external stakeholders (e.g., Central Labs, Specialty Labs, Biomarker Vendors, Companion Diagnostics) to optimize data collection services. Ensures quality delivery of all third-party data from diverse external providers for clinical trials, companion diagnostics, clinical development, and regulatory submissions. Performs validation of electronically transmitted external data, ensuring compliance with quality requirements and analysis endpoints. Requires knowledge of external data concepts, data collection methods (EDC & Non-EDC), industry standards (CDISC / SDTM), and technical skills for data integration. Oversight and execution of CDx development to support science-based decision-making are preferable. Excellent verbal/written, analytical, organizational, and interpersonal skills are essential. Demonstrated ability to work independently, collaborate effectively, and deliver results in a fast-paced environment is required. Responsibilities Leadership, Direction, and Strategy:
Lead implementation of external data collection requirements, partner with stakeholders to ensure data consistency, participate in contract reviews, and serve as a subject matter expert during study activities. Maintain and review key procedural documents, act as primary contact for escalations, and promote quality and collaboration. Project Management:
Ensure quality delivery of external data, maintain inspection readiness, support audits, and monitor vendor performance through KPIs. Functional Expertise:
Ensure external data meets protocol parameters and standards, review data transfers, oversee quality of external data, and collaborate on data specifications and integration. Operational Efficiency / Continuous Improvement:
Facilitate CDx decision-making, promote best practices, oversee diagnostics data management, and stay current with industry trends and regulations.
Skills
Minimum 4 years in external data management, vendor oversight, and knowledge of CDISC/SDTM standards. Clinical data management experience in pharma, biotech, or CRO, especially in oncology or immunology, is required. Working knowledge of EDC systems is a plus. Education
Master's degree in life sciences or related field preferred; Bachelor's degree required. RN qualification is a plus. Planet Pharma is an equal opportunity employer committed to diversity and inclusion. #J-18808-Ljbffr
Manager, External Data Management II
role at
Planet Pharma 6 days ago Be among the first 25 applicants Job Description
Target Pay Rate: 70-80.71/hr
salary will be commensurate with experience The Manager External Data Management (Level 2) is responsible for end-to-end delivery of external data in client R&D, collaborating with Clinical and Medical teams, Functional Stakeholders (QCP, Clinical Biomarkers, etc.), Clinical Safety, CROs, and External Vendors. The role supports drug development processes and global submissions by providing expertise in Data Management, partnering with internal and external stakeholders (e.g., Central Labs, Specialty Labs, Biomarker Vendors, Companion Diagnostics) to optimize data collection services. Ensures quality delivery of all third-party data from diverse external providers for clinical trials, companion diagnostics, clinical development, and regulatory submissions. Performs validation of electronically transmitted external data, ensuring compliance with quality requirements and analysis endpoints. Requires knowledge of external data concepts, data collection methods (EDC & Non-EDC), industry standards (CDISC / SDTM), and technical skills for data integration. Oversight and execution of CDx development to support science-based decision-making are preferable. Excellent verbal/written, analytical, organizational, and interpersonal skills are essential. Demonstrated ability to work independently, collaborate effectively, and deliver results in a fast-paced environment is required. Responsibilities Leadership, Direction, and Strategy:
Lead implementation of external data collection requirements, partner with stakeholders to ensure data consistency, participate in contract reviews, and serve as a subject matter expert during study activities. Maintain and review key procedural documents, act as primary contact for escalations, and promote quality and collaboration. Project Management:
Ensure quality delivery of external data, maintain inspection readiness, support audits, and monitor vendor performance through KPIs. Functional Expertise:
Ensure external data meets protocol parameters and standards, review data transfers, oversee quality of external data, and collaborate on data specifications and integration. Operational Efficiency / Continuous Improvement:
Facilitate CDx decision-making, promote best practices, oversee diagnostics data management, and stay current with industry trends and regulations.
Skills
Minimum 4 years in external data management, vendor oversight, and knowledge of CDISC/SDTM standards. Clinical data management experience in pharma, biotech, or CRO, especially in oncology or immunology, is required. Working knowledge of EDC systems is a plus. Education
Master's degree in life sciences or related field preferred; Bachelor's degree required. RN qualification is a plus. Planet Pharma is an equal opportunity employer committed to diversity and inclusion. #J-18808-Ljbffr