Job Title: Senior Clinical Data Manager
Location: Remote (India)
Job Type: Full-time
Posted: Feb. 11, 2025
Job ID: 419
Position Overview:
As a Senior Clinical Data Manager, you will serve as a key player in the data management function, working with cross-functional teams to ensure milestones and deliverables are met with quality and efficiency. You will lead data review listings, collaborate with stakeholders, resolve risks, and ensure the readiness of all Data Management Trial Master File (TMF) documents. The role is 100% remote, based in India.
Responsibilities:
Represent the data management function in cross-functional study teams.
Create and present data review listings and visualization specifications, incorporating feedback and revisions.
Lead efforts to meet milestones, deliverables, and quality standards in collaboration with stakeholders and CRO partners.
Mitigate and resolve risks, ensuring compliance with regulatory requirements.
Provide input to functional governance and address escalated issues.
Ensure TMF document readiness for audits and inspections.
Support User Acceptance Testing (UAT) of screens, edit checks, and dynamics.
Serve as a process expert for operational models and data management procedures.
Prepare metrics supporting key performance indicators (KPIs) for the function.
Represent the company in external initiatives, such as SCDM, CDISC, and DIA.
Contribute to continuous improvement initiatives to meet timelines and budgets.
Ensure compliance with learning curricula and corporate/GxP requirements.
Qualifications:
Education: Bachelor's degree in science, health-related, or information technology field.
Experience: Minimum of 6 years in Clinical Data Management.
Skills:
Expertise in data review listings, visualization specifications, and presentation to cross-functional teams.
Must have experience with Elluminate.
Experience in multiple therapeutic areas and across various phases of development is preferred.
Strong knowledge of FDA and ICH regulations, clinical trial documents (protocols, CRFs, study reports), and data management best practices.
Ability to navigate the drug development process and collaborate across cross-functional teams.
Additional Information:
Location: Fully remote position based in India.
Cytel offers a collaborative work environment with opportunities for professional growth and involvement in industry best practices.
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Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
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Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
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Birmingham |Alaska :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |Arkansas :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
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Lebanon | Manchester |New Jersey :
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Albany | Biddle | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |North Carolina :
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Prague |Republic of Egypt :
Cairo |Oxfordshire :
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Yavne | Tel Aviv | Netanya | Kfar Saba | Be'Er Sheva |Italy :
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Remote - South America (Latin Americal) | Switzerland | Remote - Africa | Remote, USA | Remote - Middle East | Remote | Remote - Europe |Bucharest :
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Khulais | Najran | Rabigh | Jeddah | Riyadh | King Abdullah Economic City |Nišava District :
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