Job Title: Senior Clinical Data Manager (Oncology Experience Preferred)
Location: Remote
Position Type: Full-Time
eCRF Development: Lead the design, refinement, and standardization of electronic Case Report Forms (eCRF), ensuring alignment with study protocols, regulatory requirements, and industry best practices.
Data Quality Management: Proactively create and implement edit checks, query logic, and data query resolution strategies to ensure data integrity, quality, and regulatory compliance.
SAE Reconciliation: Take ownership of Serious Adverse Event (SAE) reconciliation between clinical and pharmacovigilance databases, ensuring precise consistency and accuracy.
Data Management Planning: Design and execute data management plans, clinical data standards, data transfer agreements, and establish efficient data flow processes while adhering to regulatory guidelines.
Vendor Management: Manage relationships with vendors, promptly resolving data discrepancies to ensure the availability of complete and accurate datasets for analysis.
Data Migration & Closeout: Oversee data migration processes and database closeout activities, ensuring smooth transitions and full regulatory compliance.
Cross-functional Collaboration: Represent Data Management in cross-functional meetings, aligning data-centric activities and deliverables with other departments.
Project Support: Provide continuous support to project teams, proactively identifying and resolving data-related challenges to ensure project timelines and success.
Standardization Advocacy: Champion the standardization of data management practices across teams and studies to improve efficiency and consistency.
Ad-hoc Data Requests: Respond to ad-hoc data requests, assisting in data cleaning, entry, and exploratory analysis as needed.
Protocol Compliance: Review and compare data against study protocols, amendments, and manuals to ensure adherence to study requirements.
Education: Bachelor’s degree in Life Sciences, Computer Science, or related field; or equivalent practical experience.
Experience: 7+ years of clinical data management experience, with a strong focus on late-phase clinical drug development (oncology experience preferred). Must have experience in biotechnology or pharmaceutical industry settings.
Data Systems Expertise: Proficiency with various data collection and Electronic Data Capture (EDC) systems. Strong understanding of MedDRA and WHODRUG coding processes.
Leadership & Communication: Excellent interpersonal, communication, and leadership skills, with a strong focus on collaboration, attention to detail, and commitment to excellence.
CRO & Vendor Oversight: Experience in overseeing CROs and vendors, ensuring effective project execution and adherence to timelines.
Regulatory Knowledge: In-depth knowledge of clinical research standards, including FDA & ICH guidelines, GCP, GCDMP, and other relevant regulatory requirements.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Frank Scottile Blvd |Missouri :
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China | Quarry Bay |Liaoning :
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Canada |Quebec :
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Brazil | Sao paulo |Attica :
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Greece |North Island :
Auckland |New Zealand :
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Vienna |Catalonia :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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King Abdullah Economic City | Khulais | Riyadh | Rabigh | Jeddah | Najran |Kuala Lumpur :
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