Clinical Research Manager

4 weeks ago

Bengaluru, Karnataka, India Dozee Full time
Job Description

Key Responsibilities:

  • Clinical Trial and RWE Study Management: Design, plan, and manage clinical trials and RWE studies from initiation to close-out.
  • Develop Study Protocols: Develop study protocols, informed consent forms, and other essential documentation.
  • Ensure Compliance: Ensure alignment with company objectives and compliance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and regulatory requirements (FDA, EMA, etc.).
  • Manage Study Timelines: Manage study timelines, budgets, and resources to meet clinical milestones and research goals.
  • Collaborate with Data Scientists: Collaborate closely with data scientists to ensure the appropriate application of advanced data analytics techniques to extract meaningful insights from clinical data.

Scientific Writing and Documentation:

  • Author and Review Reports: Author and review scientific reports, clinical study reports, abstracts, and peer-reviewed manuscripts.
  • Contribute to Regulatory Submissions: Contribute to the preparation of documents for regulatory submissions, including protocols, informed consent forms, and Investigator's Brochures.
  • Ensure Scientific Integrity: Ensure that all documentation follows scientific integrity, clarity, and accuracy guidelines.

Regulatory and Ethical Compliance:

  • Prepare Regulatory Documents: Prepare and submit regulatory documents to ethics committees and institutional review boards (IRBs).
  • Stay Updated on Regulatory Developments: Stay updated on regulatory and industry developments, ensuring studies comply with current legal and ethical guidelines.

Data Management and Reporting:

  • Oversee Data Collection: Oversee data collection, quality control, and statistical analysis, particularly in collaboration with study sites and data scientists.
  • Ensure Accurate Reporting: Ensure accurate and timely reporting of clinical trial and RWE study outcomes.

Team Leadership and Collaboration:

  • Lead and Mentor Team Members: Lead and mentor clinical research coordinators, associates, and scientific writing staff.
  • Collaborate with External Partners: Collaborate with external clinical investigators, study sites, and other vendors to ensure seamless study execution.

Risk Management and Problem Solving:

  • Identify and Mitigate Risks: Identify and mitigate risks during clinical trials and RWE studies to prevent delays or non-compliance.

Stakeholder Communication:

  • Serve as Primary Point of Contact: Serve as the primary point of contact for study sites, investigators, external partners, and regulatory bodies.

Qualifications:

  • Bachelor or Master's Degree: Bachelor or Master's degree in Life Sciences, Nursing, Pharmacy, Dental Surgery (BDS), or a related field.
  • Minimum 6+ Years of Experience: Minimum of 6+ years of experience in clinical research, with 2+ years in a managerial role.
  • Demonstrated Experience: Demonstrated experience in conducting RWE studies, clinical trials, and observational research.
  • Proven Track Record: Proven track record in scientific writing, including authoring manuscripts, reports, and regulatory submissions.
  • Strong Knowledge: Strong knowledge of clinical trial regulations, ICH-GCP, FDA, EMA, and other relevant regulatory requirements.

Key Competencies:

  • Expertise in Clinical Research: Expertise in clinical research and Real World Evidence methodologies.
  • Strong Analytical Skills: Strong analytical skills and ability to interpret complex datasets in collaboration with data scientists.
  • Excellent Scientific Writing Skills: Excellent scientific writing and communication skills, with the ability to translate research findings into publications and reports.
  • Leadership and Mentoring Abilities: Leadership and mentoring abilities for managing cross-functional research teams.

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