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.
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Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Visakhapatnam |Assam :
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Delhi | India | New Delhi | PAN-India |Goa :
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Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
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Rangpo |Tamil Nadu :
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Hilo | Honolulu |Idaho :
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Frank Scottile Blvd |LA :
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Bangor | Brewer |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake |Minnesota :
Duluth | Eden Prairie | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
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Farmington | Santa Fe | Tucumcari |New York :
Albany | Biddle | Buffalo | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Rensselaer | Syracuse | Utica |North Carolina :
Concord | Lumberton | North Carolina |North Caroline :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |North Dakota :
Dickinson |northeastern :
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Memphis | Nashville |Texas :
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Ciudad de México |Cebu Province :
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Warsaw |Remote :
Remote, USA | Remote | Remote - Middle East | Remote - Europe | Switzerland |Bucharest :
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Khulais | Najran | Riyadh | King Abdullah Economic City | Jeddah | Rabigh |Nišava District :
Niš |Singapore :
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