Senior Clinical Data Manager
Company: Bristol Myers Squibb (BMS)
Location: Hyderabad, Telangana, India
Department: Clinical Data Management
Job Type: Full-Time (Hybrid)
JOB OVERVIEW
The Senior Clinical Data Manager is responsible for providing end-to-end clinical data management leadership to ensure the integrity, quality, completeness, and reliability of clinical trial data across the Bristol Myers Squibb R&D portfolio. The role oversees clinical data review, external data management, data cleaning, query resolution, documentation, and mentoring of junior Clinical Data Management staff while ensuring compliance with ICH-GCP, FDA regulations, and industry standards.
KEY RESPONSIBILITIES
Clinical Data Review
Review clinical study protocols and study-specific data review documents.
Develop and provide input to Protocol Data Review Plans (PDRP).
Contribute to Data Quality Management Plans (DQMP).
Review and prioritize critical clinical data listings.
Ensure data accuracy, completeness, and consistency.
Perform comprehensive clinical data validation.
Data Cleaning & Query Management
Perform data cleaning activities according to Clean Patient Group (CPG) requirements.
Identify, review, and resolve data discrepancies.
Generate, track, and close clinical data queries.
Ensure timely resolution of outstanding data issues.
Support database readiness for interim analyses and database lock.
CRF & Database Management
Review electronic Case Report Forms (eCRFs).
Freeze and lock CRFs and database fields.
Monitor data quality throughout the study lifecycle.
Support database freeze and database lock activities.
Ensure compliance with study timelines.
External Data Management
Track external data transfers and data loads.
Review external datasets for quality and completeness.
Manage complex external data reconciliation including:
Biomarker Data
Serious Adverse Event (SAE) Data
Blinded Independent Committee Review Data
Coordinate discrepancy resolution with external vendors.
Ensure successful integration of external clinical data.
Study Coordination
Coordinate with Clinical Data Management Leads.
Support study startup, conduct, and closeout activities.
Monitor clinical data management deliverables.
Ensure study milestones are achieved on schedule.
Documentation Management
Maintain Trial Master File (TMF) documentation.
File study documents within the Electronic Trial Master File (eTMF).
Ensure documentation complies with the eTMF Master Plan.
Maintain inspection-ready documentation.
Training & Mentorship
Train junior Clinical Data Managers.
Mentor team members on clinical data review activities.
Share best practices in clinical data management.
Support onboarding of new CDM staff.
Cross-Functional Collaboration
Collaborate with Clinical Operations teams.
Work closely with Biostatistics.
Coordinate with Medical Monitors.
Partner with Clinical Programmers.
Communicate with external data vendors.
Support multidisciplinary project teams.
Compliance & Quality
Ensure compliance with ICH-GCP guidelines.
Follow FDA regulations and industry standards.
Maintain high standards of data integrity.
Support audit and inspection readiness.
Adhere to company SOPs and quality management processes.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree.
Preferred
Life Sciences
Pharmacy
Biotechnology
Biomedical Sciences
Biochemistry
Related Scientific Discipline
EXPERIENCE REQUIREMENTS
Required
Minimum 4 years of experience in Clinical Data Management.
Experience performing clinical data review activities.
Experience with clinical trial data validation.
Experience using Electronic Data Capture (EDC) systems.
Strong understanding of the clinical drug development process.
Preferred
Experience with Medidata Rave.
Experience managing external clinical data.
Experience mentoring junior team members.
Experience supporting global clinical trials.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Birmingham |Virginia :
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Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
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Lake Charles | Shreveport |Nevada :
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Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
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Tuscaloosa |D.C :
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Wilmington |North Rhine Westphalia :
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Hamburg |Rhineland Palatinate :
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Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
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Dún Laoghaire |Galway :
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China | Quarry Bay |Liaoning :
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Shanghai Shi |Hubei :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Mississauga | North York | Renfrew | Richmond Hill | Australia | Uxbridge |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
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Kyiv |Lima Region :
Lima |France :
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Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |
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