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Manager - Scientific Affairs / Medical Services

0-2 years
Not Disclosed
10 Dec. 19, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Manager - Scientific Affairs / Medical Services
Company: Lambda Therapeutic Research Ltd.
Location: Ahmedabad, India
Date: Nov 25, 2024

Organizational Overview:
Lambda Therapeutic Research is a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad, India, with additional offices in Mehsana (India), Las Vegas (USA), Pittsburgh (USA), Toronto (Canada), London (UK), and Warsaw (Poland). The company offers comprehensive end-to-end clinical research services to the innovator, biotech, and generic pharmaceutical industries. Lambda has earned numerous accolades, including the "Best Indian CRO" by Frost & Sullivan and the "Regulatory Excellence" award at the CPhI Awards 2023.

Key Deliverables:

  • Maintain scientific and clinical knowledge in assigned disease areas.
  • Ensure familiarity with clinical study documentation, regulatory requirements, and operational procedures.
  • Participate in clinical study team meetings and present project updates.
  • Act as a medical monitor for assigned studies, offering clinical expertise.
  • Conduct medical data reviews, identifying trends, outliers, and protocol violations.
  • Visit study sites for inspections, training, and meetings as necessary.
  • Collaborate with Lead-MM on study execution and reporting.

Allied Responsibilities:

  • Core knowledge in clinical research practices (GCP, drug development, biostatistics).
  • Demonstrate high ethical standards and GCP compliance.
  • Effective interpersonal skills and the ability to influence without authority.
  • Solid understanding of the clinical research industry and drug development processes.
  • Proficient in Microsoft Office and virtual platforms.
  • Travel required: Approximately 30% domestic travel.

Experience:

  • 0-2 years of experience in clinical research, preferably in a pharmaceutical, biotech, or CRO setting.

Educational Qualification:

  • Minimum of a bachelor’s degree in clinical medicine (advanced degree, e.g., MD, preferred).

Competencies:

  • Accountability, communication, work ethic, initiative, leadership, and organizational fit.
  • Strong interpersonal and presentation skills.