Education & Career Trends: October 3, 2022
Curated by the Knowledge Team of ICS Career GPS
Clinical research and clinical trials are important for developing new medicines that can safely be administered to patients. Clinical research helps medical experts evaluate the safety and effectiveness of drugs, medical devices, and diagnostic products. Due to its critical role in ensuring the safety and efficacy of medicines and medical devices, this is a highly regulated field. Any role within this domain is highly demanding, with a plethora of responsibilities riding along the regular work.
Regardless of the combination, strong communication, management skills, operational knowledge, strategic thinking, agility, risk-based approach, patient centricity, and the ability to operate in diverse teams will continue to be indispensable for the drug development professionals of today and tomorrow.
Useful Data Skills
As biopharmaceutical research and advanced research disciplines transform into more data-rich operations, clinical research professionals must be equipped with the skills to distil actionable insights from the vast clinical and patient-generated health data sets.
- Expertise in analytics, risk-based approaches, and advanced data science capabilities are becoming attractive in biopharmaceutical industries.
- Digital transformation is advancing rapidly, and the focus today has shifted from adopting specific technologies to rapidly establishing new operating models and adopting new solutions.
- Drug development stands to benefit greatly from the increased exchange of knowledge and improved best practices for collecting, organising, storing, sharing, exchanging, analysing, interpreting, and communicating data.
- Such a transformation requires a high degree of adaptability at all levels.
- Innovations such as robotics, Artificial Intelligence (AI), Machine Learning (ML)/Natural Language Processing (NLP), Internet of Things (IoT), in silico clinical trials (ISCTs), as well as blockchain-based trials and digital health are expected to improve productivity and resource optimisation.
Ecosystem and Opportunities
Industry clinical research is conducted by the pharmaceuticals, biotech and medical device sponsor companies. These companies may either conduct the trials in-house or outsource some or all work to Contract Research Organisations (CRO) and 3rd party vendors. The CROs and vendors conduct the clinical trials on behalf of the sponsor company in collaboration with the site/hospital or Site Management Organisation (SMO).
Some key stakeholders in the entire clinical trial process are as follows:
- Industry sponsors: Companies that are into pharmaceuticals, biotechnology, medical device manufacturing, CROs
- Research sites: Site/hospital or SMO
- Vendors: Central lab, patient recruitment, clinical trial technology, EDC, CTMS etc., logistics and courier services
- Regulatory agency: Country-specific
Each one of them has various roles. Understanding basic information related to various job opportunities, including their basic job profile and how the responsibilities differ from sponsor, CRO/vendor, or hospital (site) is important to figure out the opportunities.
For example, document management and an electronic trial master file (eTMF) are critical parts of drug development. Those interested in pursuing a career in document management must understand the basics of document management, research the available job opportunities and future growth prospects, and understand how the responsibilities differ between the sponsor, CRO, and vendor companies.
Individuals with software development/validation skills could also explore opportunities at vendor companies involved in developing eTMF applications/software.
Having a life science or medical degree is one of the strongest educational backgrounds for clinical research entry-level positions:
- Medical and allied fields: MBBS / BDS / BAMS / BHMS / BVSc / BSMS/Nursing
- Pharmacy: BPharm / MPharm/ Pharm.D.
- Life Sciences: BSc/MSc/PhD (Botany, Zoology, Chemistry, Biotechnology, Biochemistry, Microbiology, Genetics)
- Engineering: BE, BTech, MTech (Biotechnology), AI and Machine Learning, etc.,
Areas with Good Opportunities
1. Clinical Monitoring
- Includes risk-based monitoring, remote monitoring, centralised monitoring, hybrid monitoring, decentralised clinical trials, virtual trials, remote project management support, trend and risk analysis, and review of key metrics and indicators.
- Clinical Trial Management Software, cloud-based operational systems, electronic data capture, electronic trial master file, randomisation — IWRS/IVRS or IRT, trial supply management
- Patient recruitment and retention services, translation services, imaging vendors, investigator/site payment systems
2. Patient-Centric Technologies
- It includes eConsent, eSource, eDiaries, digital pills, virtual site operations, electronic medical records (EMRs), telemedicine, home visits, apps, portals, and surveys.
- Clinical outcome assessment, patient-reported outcome, clinician-reported outcome, observer-reported outcome or performance outcome instruments
- Digital Therapeutics, digital endpoints, diagnostics, wearable devices/sensors (e.g., health-tracking wristbands, smart watches, mobile devices, wearable glucose patches, wearable sensors, etc.)
3. Quality of Life Index Scales and Questionnaires
- This includes avenues like rating scale development/validation and scale translation/cultural adaptation.
- Medical writing, training, investigator meeting management, KOL management, patient advocacy, data disclosure, and privacy also come under this.
Some of these opportunities may not exist currently in large volumes but may arise in the future upon the implementation of newer technologies
Have you checked out yesterday’s blog yet?
(Disclaimer: The opinions expressed in the article mentioned above are those of the author(s). They do not purport to reflect the opinions or views of ICS Career GPS or its staff.)