Med Data Review Associate Manager
Location: Bangalore
Employment Type: Full Time
Job Overview
The Med Data Review Associate Manager is a key member of the Global Medical Review Team responsible for executing Central Medical Review activities within the Central Monitoring strategy. The role involves collaborating with cross-functional stakeholders, supporting study teams and sponsors, managing medical review processes, identifying patient safety concerns, and ensuring effective utilization of the Xcellerate® Medical Review (XMR) platform throughout the clinical trial lifecycle.
The position supports Central Monitoring and Central Medical Review activities from study startup through study completion while maintaining compliance, inspection readiness, and high-quality deliverables.
Summary of Responsibilities
Central Medical Review & Monitoring
Execute Central Medical Review activities in accordance with approved Central Monitoring and Central Medical Review Plans.
Collaborate with study teams, project physicians, and clients to ensure successful execution of Central Monitoring strategies.
Conduct ongoing medical review of clinical trial data at the patient and site level.
Identify, assess, and communicate medical findings and potential patient safety concerns.
Escalate findings and risks to Project Physicians and relevant stakeholders.
Ensure identified issues are tracked through resolution and appropriately documented.
Safety Signal Detection & Risk Management
Evaluate and identify potential safety signals using:
Individual case assessments
Aggregate data reviews
Signal detection methodologies
Contribute to risk assessments and categorization activities related to medical review.
Support proactive risk identification and mitigation strategies.
Study Design & Configuration Support
Contribute to proposal development, costing reviews, and bid defense presentations involving Central Medical Review services.
Support Data Experts in:
Critical Data Definition
Critical Process Definition
EDC Design Implementation
Assist in defining medical review requirements and visualization specifications.
Ensure consideration of all relevant study data sources, including:
EDC Data
Laboratory Data
Safety Data
Other Clinical Data Sources
Xcellerate® Medical Review (XMR) Management
Draft and maintain the Central Medical Review Configuration Plan.
Configure study-specific settings within the Xcellerate® Medical Review (XMR) platform.
Program study-specific visualizations and dashboards within XMR.
Perform User Acceptance Testing (UAT) of XMR configurations.
Maintain and update configurations throughout the study lifecycle.
Documentation & Reporting
Draft and maintain:
Central Monitoring Plans
Central Medical Review Plans
Configuration Plans
Medical Review Reports
Generate and communicate data-driven insights to project teams and sponsors.
Ensure accurate tracking and status reporting throughout the study.
Support preparation of study reports and medical review deliverables.
Quality & Compliance
Ensure inspection readiness of all medical review activities.
Support regulatory inspections and audits when required.
Maintain compliance with:
ICH-GCP Guidelines
Clinical Trial Regulations
Sponsor Requirements
Internal SOPs
Process Improvement & Innovation
Identify and recommend process improvements.
Evaluate opportunities for enhancing systems, tools, and workflows.
Submit recommendations and business justifications to leadership.
Support continuous improvement initiatives across the Central Monitoring function.
Training & Mentorship
Provide project-specific and process-related training to team members.
Mentor and support onboarding of new team members.
Share best practices and promote knowledge transfer across teams.
People Management Responsibilities (Where Applicable)
Manage direct reports and monitor performance objectives.
Ensure training records and compliance requirements are maintained.
Support recruitment and onboarding activities.
Conduct performance reviews and development discussions.
Cascade key business updates and organizational communications.
Support workforce planning and departmental operations.
Ensure smooth functioning of the Central Monitoring team.
Perform additional duties as assigned.
Qualifications (Minimum Required)
Medical Degree (MBBS or equivalent), OR
Allied Medical Degree, OR
Postgraduate Degree in Life Sciences, Clinical Sciences, Pharmacy, Biotechnology, or a related discipline.
Equivalent experience may be considered in lieu of formal educational qualifications.
Experience (Minimum Required)
Experience in:
Clinical Research
Medical Monitoring
Central Monitoring
Medical Review
Pharmacovigilance
Drug Safety
Clinical Data Review
Strong understanding of:
Clinical Trial Processes
Patient Safety Assessment
Risk-Based Monitoring
Clinical Data Analysis
Experience working with:
Electronic Data Capture (EDC) Systems
Medical Review Platforms
Clinical Trial Databases
Central Monitoring Tools
Strong analytical and problem-solving skills.
Excellent communication and stakeholder management capabilities.
Ability to work within a matrix and global environment.
Preferred Qualifications
Medical background with experience in Clinical Development or Medical Monitoring.
Experience with:
Xcellerate® Medical Review (XMR)
Central Monitoring Platforms
Risk-Based Monitoring Programs
Safety Signal Detection Activities
Prior experience mentoring or managing team members.
Experience supporting sponsor interactions and bid defense activities.
Uttar Pradesh :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Rangpo |India :
Remote, India | Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Boulder | Denver | Westminster |Connecticut :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
Knoxville | Memphis | Nashville |Louisiana :
Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
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Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
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Washington |Delaware :
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Berlin |Baden-Wurttemberg :
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Darmstadt | Marburg |Hessen :
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Germany | GErmany |Lower Saxony :
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Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
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Basel | Zurich |Serbia :
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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 :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
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Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
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Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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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 | Australia | Uxbridge | Richmond Hill |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
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Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
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Almaty |Republic of Thailand :
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Be'Er Sheva | Tel Aviv | Netanya | Yavne | Kfar Saba |Remote :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |
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