Senior Clinical Research Consultant

1 week ago

Mumbai, Maharashtra, India beBeeClinicalResearch Full time

Job Opportunity

We are seeking a skilled professional to join our team as a Clinical Research Advisor. As a key member of our organization, you will play a vital role in the development of global clinical trials.
The successful candidate will be responsible for providing medical oversight for all trials, portfolio and/or protocol medical feasibility, scientific engagement of investigators, protocol and TA training for internal and external stakeholders, medical issue or question management, safety review, strategic input in pre-launch planning.
You will drive compliance across all aspects of clinical trials and related activities. It is critical to ensure good communication and stakeholder management cross-functionally within the local country organisation as well as between global and regional teams.

Key Responsibilities:

  • Medical oversight of clinical trials across all stages and contribute to operational trial deliverables, according to timelines, quality/compliance, and performance standards.
  • Drive portfolio/trial medical feasibility within the Global Development framework and provide country clinical strategic guidance and proposals in collaboration with Study and Site Operations Team and Medical Affairs Team.
  • Identify and propose new sites for clinical trials, analyse capability, assess patient pool and country treatment landscape, and make recommendations for potential trial inclusion.
  • Provide robust indication and protocol training to CRAs, CSMs, RSMs and other functions in the country as needed.
  • Responsible for medical related education, implementation and compliance to protocol, standards (SOPs) and best practices for clinical development within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned.
  • Provide medical expertise to clinical/operational activities for patient eligibility, medical question-management, safety, amendments, etc.
  • Collaborate cross-functionally for the early product launch planning process to ensure Global Development trials conducted are aligned with the local country strategy.
  • Support medical/clinical team discussions with local regulatory interactions as needed.

Requirements:

  • Medical Degree (MD, MBBS).
  • Proven experience in medical practice or pharmaceutical industry experience with a background in clinical trials/medical affairs/life sciences/research in all aspects of drug development including clinical research, GCP, and local regulatory requirements.
  • Demonstrated experience in managing projects, feasibility conduct and the execution of strategic plans from a medical perspective.
  • Outstanding internal and external stakeholder engagement experience.

Skills Desired:

  • Clinical Practices.
  • Clinical Trials.
  • Drug Development.
  • Hazard Identification.
  • Health Sciences.
  • Immunology.
  • Organization Skills.
  • Patient Care.
  • Stakeholder Engagement.

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