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Clinical Research Scientist

3 months ago

Mumbai, India KlinEra Global Services Full time

About the Company:

We are seeking a Clinical Scientist who will serve a key role in contributing to the scientific planning and collaborate with Clinical Research, Pharmacovigilance, and Clinical Operations in the execution of one or more clinical trials or significant aspects thereof. In this position, you will have the opportunity to demonstrate your leadership, technical skills, and scientific acumen as part of a cross-functional clinical development team. You will be a key contributor in the clinical science activities of evidence generation for regulatory approval and/or engagement with physicians, including protocol development, study implementation, data analysis, and reporting of results.


About the Role:

You are a data-driven and collaborative integrator who is passionate about driving the development and execution of therapeutic strategy that enables innovative pipeline impact and delivery of transformative medicines to patients. You have exemplary communication and presentation skills and can lead study development by applying the most current electronic document conventions/processes consistently to ensure scientific and data integrity.


Responsibilities:

  • Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s). This may include:
  • Serving as the lead clinical scientist on the clinical trial team
  • Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with Clinical Research and Pharmacovigilance
  • Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents/amendments); partnering with Clinical Operations on study deliverables
  • Ensure CRF design supports data collection in alignment with the Protocol in collaboration with Clinical Data Management/Programming
  • Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of trial conduct
  • Providing tactical/scientific mentorship to other clinical scientists
  • Responsible for assisting with the generation, analysis, and presentation of clinical data, including manuscripts, abstracts, and oral presentations (including authoring documents and slide preparation as appropriate)
  • Apply proficient analytical knowledge and skills to understand how program objectives and design impact data analysis; identify risks and design mitigation strategies
  • Promotes consistent first-line medical/clinical data review techniques and conventions across studies/programs


Qualifications:

  • Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
  • Ability to manage multiple competing priorities with good planning, time management, and prioritization skills
  • Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions
  • Proficient scientific expertise to propose, design, and execute clinical research and development studies, and author documents related to clinical trials, such as medical monitoring plans, SAPs, informed consent, and clinical components of the Clinical Study Reports
  • Interact with key stakeholders across Clinical Development functional areas
  • Role requires a proactive approach, strategic thinking, and leadership in driving toward clinical study goals
  • Influence opinions and decisions of internal and external customers/vendors, across functional areas
  • Problem-solving, prioritization, conflict resolution, and critical thinking skills
  • Strong communication, technical writing, and presentation skills experience
  • Experience within oncology preferred.