Chief Medical Research Officer

3 days ago

Hyderabad Secunderabad Telangana, India beBeeRegulatory Full time
Job Title:

Senior Clinical Research Specialist

Job Description:

As a Senior Clinical Research Specialist, you will play a pivotal role in ensuring the successful execution of clinical trials. Your primary responsibility will be to provide medical support to Clinical Program Leaders (CPLs) and contribute to the development of clinical trial protocols and documents.

Key responsibilities include:

  • Providing medical expertise to CPLs and contributing to the development of clinical sections of protocols, Informed Consents, and regulatory documents.
  • Acting as a medical monitor to support overall program safety reporting and collaborating with the Patient Safety Team.
  • Representing CPLs at project team meetings and providing inputs to project strategy.
  • Overseeing the clinical/scientific elements of TCO-related submission documents and preparing project documentation for Health Authority submission.

Additional responsibilities include leading ongoing clinical trial data medical/scientific review across assigned TCO studies, coordinating data analysis and interpretation, and mentoring junior team members. You will also be responsible for maintaining expert knowledge of ICH-GCP, external regulations, and procedures, as well as supplementing this knowledge through training and practice of Novartis SOPs and internal policies.

Required Skills and Qualifications:

Education:

  • MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area, such as internal medicine/pharmacology, are also required.

Work Experience:

  • At least 5 years of pharmaceutical/biotech industry experience.
  • At least 2 years of clinical practice experience in a hospital setting.
  • Experience with oncology clinical trials and early development clinical trials.
  • Knowledge of Good Clinical Practice (GCP).
Benefits:

Strategic thinking and ability to network with key stakeholders.

Clear written and verbal expression of ideas, with excellent interpersonal skills.

Ability to work independently and in a team, being flexible and adaptable in a changing environment.

Others:

Strong operational project experience, including excellent planning, prioritization, problem-solving, and organizational skills.

Demonstrated operational excellence and scientific contribution to both clinical and preclinical projects.

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