With more than 16 years of experience, Mr Kanishk is a lead educator in the new age. He has several awards and honours to his name such as India Today Award and President Award. He operates to make Indian youth job-ready and equipped with the right skill-sets across industries.
Clinical Trial industry is the field that offers number of career opportunities to doctors, science and pharma graduates. Currently, the industry is facing a shortage of trained professionals and is looking for over 70,000 professionals. Since the industry is doubling every year and the Covid19 has been the single biggest contributor in the rise of the industry, people have now understood the benefits of clinical trials as the human race can only survive when the vaccine development is ensured through clinical trials.
Clinical Research professionals in India can work in the following organizations:
- Pharma Companies
- Biotech Companies
- Clinical Research Organizations (CRO)
- Site Management Organizations (SMO)
- IT Companies (Clinical Data Management)
Since the Clinical Research industry provides different career options to all professionals having science and medical background:
For Doctors: Principal Investigators / Co-investigator / Medical Advisor / Drug Developers / Regulatory Affairs Manager / Clinical Research Physician.
For Paramedics, Pharmacists & Life Science Graduates: Medical Writers / Clinical Research Associates / Site coordinators / Clinical Research Manager / Drug Development Associates / Clinical Data Management / Pharmacovigilance Executive / Clinical Trail analyst / Drug Reviewer / Drug Safety Physician & many more
For Management Professionals: (with Life Science/Health Science background) Business Development / Clinical Project Management / Clinical Research Management / Regulatory Affairs.
Roles and their KRAs:
Clinical Research Associates: To monitor clinical trials, ensure compliance with the clinical trial protocol, checks clinical sites activities, make on-site visits, CRFs.
Clinical Research Investigators: Conduct BA/BE studies, writing / revising SOP, review of protocols, investigators brochures, ICF & CRFs Protocol, CRF & ICF preparations plans and conduct of BA/BEIEC/IRB affairs-GC.
Study Coordinators: Provides safety & protection while collecting & managing the study data.
Data Manager / Biostatistician: Design, study & predict the seriousness of the disease, seriousness of the disease, evaluate new treatment and effectiveness of medication, participate in research design, data collection, choosing & implementing appropriate methodologies, interpreting the results.
Regulatory Affairs Managers: Review & registration of documents, evaluation of technical data, liaison with regulatory authorities.
Clinical Trials Auditors: Conducts audits for regulatory function within the trial department to assure compliance with GLP/GCP in accordance with established FDA regulations and company policies & standard operating procedure.
Clinical Research Managers: Manage, supervise, train, mentor clinical research staff, approve investigator’s study, budget & contract, review & approve regulatory documents, develop a protocol, approve CRFs, review study data.
Business Development Manager: Identify potential clients, establish business relations, responsible for meeting new clients, following up on leads, market research.
Drug Safety Associate: Manage & relay drug safety information, maintain current knowledge of global drug safety regulations, summarize clinical safety data, write narratives with medical input, report SADRs to Regulatory Authorities, participate in training on drug safety issues & another task under drug safety.
Medical Writer: Documentation, manuscripts, abstracts, external communication tools Clinical Data Manager: Ensures the accuracy & consistency of data prepared for regulatory bodies for reporting purpose.
Others: Auditors, Quality Assurance, Patents & IP Related position