Job Title: Clinical Research Lead
Location: India (Hyderabad/Mumbai)
Job Type: Permanent, Full-time
Our Team:
Sanofi Business Operations is an internal resource organization based in India that centralizes processes and activities to support various functions, including Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data & Digital. The team works to support Medical, HEVA, and Commercial teams globally.
The Clinical Research Lead (CRL) will be responsible for overseeing clinical research activities, including the design, implementation, and monitoring of clinical trials. The CRL will ensure trials meet regulatory standards and align with organizational goals.
Key Responsibilities:
Clinical Development: Lead activities related to the Clinical Development Plan (CDP), Integrated Development Plan (IDP), product value proposition (TVP), target product profile (TPP), and market access strategy.
Medical Input: Provide medical support for clinical studies, including feasibility, medical review of data, documents, and communications to stakeholders. Ensure that medical queries from Health Authorities, Investigators, and study teams are addressed effectively.
Safety and Data Review: Conduct medical reviews of clinical trial data, including safety events and coding, and oversee centralized monitoring activities like data validation, protocol deviations, and key risk indicator (KRI) review.
Study Protocols: Lead the creation, amendments, and medical content of study protocols, including Informed Consent Documents (ICD). Ensure that all clinical documentation is in compliance with GCP, SOPs, and regulatory requirements.
Collaboration with Stakeholders: Collaborate with cross-functional teams, including Regulatory Affairs, Biostatisticians, Pharmacovigilance, Medical Affairs, and Clinical Operations, to ensure optimal study execution.
Regulatory Submissions: Contribute to the preparation and review of clinical documents such as Investigator Brochures, Clinical Study Reports, Lay Summaries, and Clinical Trial Authorization dossiers. Lead briefing packages for regulatory agencies.
Training and Presentations: Provide medical training, prepare presentations, and participate in Investigator meetings. Assist in managing adjudication and steering committees, if applicable.
Experience:
Soft Skills:
Technical Skills:
Education:
Languages:
At Sanofi, we are committed to advancing progress in medicine through collaboration, innovation, and diversity. We provide equal opportunities for all employees, regardless of background. Join us and make a significant impact on patient care and medical knowledge.
Diversity and Inclusion:
We strive to create an inclusive environment, offering equal opportunities for everyone. Learn more about our Diversity, Equity, and Inclusion initiatives.
Apply now to be part of a transformative journey in clinical research!
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Bilaspur | Eot Municipality | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
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Ahmedabad | Baroda | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
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Siliguri |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |Odisha :
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Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Sikkim :
Rangpo |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |Uttar Pradesh :
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Dehradun | Nainital | Rishikesh |West Bengal :
Kolkata | Mukundapur |Alabama :
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Chandler | Kingman | Lake Havasu City | Peridot | Phoenix | Tempe | Tucson | Yuma |Arkansas :
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Boca Raton | Clearwater | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Jacksonville | Maitland | Miami | Naples | Orlando | Pembroke Pines | Port St. Lucie | Rueil-Malmaison | Stuart | Tallahassee | Tampa | West Palm Beach |Georgia :
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Prague |Republic of Egypt :
Cairo |South Yorkshire :
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Turku |France :
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Greece |East Java :
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Italy |Lombardy :
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Almaty |Remote Korea :
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Kuala Lumpur |Mexico :
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Warsaw |Remote :
Remote, USA | Remote | Remote - Europe | Switzerland | Remote - Middle East |Bucharest :
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King Abdullah Economic City | Riyadh | Najran | Rabigh | Jeddah | Khulais |Nišava District :
Niš |Singapore :
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Midrand |Brazil :
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Argentina |Catalonia :
Barcelona |Madrid :
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Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
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