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Clinical Research Lead

3+ years
Not Disclosed
10 Feb. 6, 2025
Job Description
Job Type: Full Time Education: MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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Clinical Research Lead | Hyderabad, India | Permanent | Sanofi

Posted on: Jan. 03, 2025
Closing on: Feb. 28, 2025


About the Job:

Sanofi Business Operations is seeking a Clinical Research Lead (CRL) to oversee and manage clinical research activities within the organization. The CRL will be responsible for designing, implementing, and monitoring clinical trials, ensuring they meet regulatory requirements and organizational goals. This role requires a robust background in clinical research, leadership abilities, and a commitment to advancing medical knowledge and patient care.


Key Responsibilities:

  • Strategic Contributions: Contribute to Clinical Development Plans (CDP), product value propositions (TVP), and market access strategies in collaboration with relevant functions.
  • Medical Support: Provide medical input and support across all activities related to clinical studies, including medical training, feasibility, medical review of data, and communications with stakeholders.
  • Data Review: Oversee the medical review of clinical trial data, safety event assessments, and coding of events and drugs.
  • Centralized Monitoring: Responsible for centralized monitoring activities, including patient data validation, safety reviews, and key risk indicator assessment.
  • Protocol and Informed Consent: Develop and amend clinical protocols and informed consent documents.
  • Documentation and Submissions: Prepare and review key clinical documents, such as Clinical Study Reports, Investigator Brochures, and Clinical Trial Authorization dossiers.
  • Collaboration: Work closely with internal and external stakeholders, ensuring optimal study execution in compliance with GCP, laws, and SOPs.
  • Team Management: Manage clinical scientists as needed and collaborate with cross-functional teams including medical affairs, pharmacovigilance, biostatisticians, and CROs.

About You:

  • Experience: Proven scientific and medical expertise, with a track record in clinical development. Phase 3 experience is a plus.
  • Soft Skills: Advanced leadership, communication, and interpersonal skills; ability to work in a matrix environment and manage cross-functional teams.
  • Technical Skills: Expertise in pulmonary, allergy, or immunology clinical knowledge; proficiency in interpreting clinical trial data and understanding relevant pre-clinical and clinical data.
  • Education: Medical Doctor (MD)
  • Languages: Fluent in English (both written and spoken).

What We Offer:

At Sanofi, we provide equal opportunities to all individuals, embracing diversity and inclusivity across all levels of the organization.