Clinical Research Manager

4 weeks ago

Bengaluru, Karnataka, India Dozee Full time

Clinical Research Manager Job Description

Dozee is seeking a highly skilled Clinical Research Manager to lead our clinical trials and RWE studies. As a key member of our team, you will be responsible for designing, planning, and managing clinical trials and RWE studies from initiation to close-out.

Key Responsibilities:

  • Design, plan, and manage clinical trials and RWE studies from initiation to close-out.
  • Develop study protocols, informed consent forms, and other essential documentation.
  • 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, budgets, and resources to meet clinical milestones and research goals.
  • 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 scientific reports, clinical study reports, abstracts, and peer-reviewed manuscripts.
  • Contribute to the preparation of documents for regulatory submissions, including protocols, informed consent forms, and Investigator's Brochures.
  • Ensure that all documentation follows scientific integrity, clarity, and accuracy guidelines.

Regulatory and Ethical Compliance:

  • Prepare and submit regulatory documents to ethics committees and institutional review boards (IRBs).
  • Stay updated on regulatory and industry developments, ensuring studies comply with current legal and ethical guidelines.
  • Maintain proper documentation and ensure all study-related materials are archived according to regulatory and company standards.

Data Management and Reporting:

  • Oversee data collection, quality control, and statistical analysis, particularly in collaboration with study sites and data scientists.
  • Ensure accurate and timely reporting of clinical trial and RWE study outcomes.
  • Present findings at internal meetings, external conferences, and publish in scientific journals.

Team Leadership and Collaboration:

  • Lead and mentor clinical research coordinators, associates, and scientific writing staff.
  • Collaborate with external clinical investigators, study sites, and other vendors to ensure seamless study execution.
  • Work with cross-functional teams, including medical, regulatory, data management, and data science teams to drive study success.

Risk Management and Problem Solving:

  • Identify and mitigate risks during clinical trials and RWE studies to prevent delays or non-compliance.
  • Proactively address operational and technical issues related to trial execution.

Stakeholder Communication:

  • Serve as the primary point of contact for study sites, investigators, external partners, and regulatory bodies.
  • Provide clear and concise updates on study progress to senior management, regulatory authorities, and other stakeholders.
  • Collaborate with key opinion leaders (KOLs), medical affairs teams, and data scientists to align research with strategic objectives.

Other Tasks:

  • Carry out additional tasks and responsibilities as assigned by the reporting manager, contributing to the overall success of the clinical research team and project objectives.

Qualifications:

  • Bachelor or Masters degree in Life Sciences, Nursing, Pharmacy, Dental Surgery (BDS) or a related field.
  • Minimum of 6+ years of experience in clinical research, with 2+ years in a managerial role.
  • Demonstrated experience in conducting RWE studies.
  • Clinical trials and observational research.
  • Proven track record in scientific writing, including authoring manuscripts, reports, and regulatory submissions.
  • Strong knowledge of clinical trial regulations, ICH-GCP, FDA, EMA, and other relevant regulatory requirements.
  • Experience in collaborating with cross-functional teams and leveraging advanced data analytics is highly desirable.

Key Competencies:

  • Expertise in clinical research and Real World Evidence methodologies.
  • Strong analytical skills and ability to interpret complex datasets in collaboration with data scientists.
  • Excellent scientific writing and communication skills, with the ability to translate research findings into publications and reports.
  • Leadership and mentoring abilities for managing cross-functional research teams.
  • Detail-oriented and highly organized, capable of managing multiple projects simultaneously.

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