Newer avenues in clinical research

Clinical research is turning out to be a hot career field

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.

Clinical trials involve testing new drugs, formulations and medical devices for general use. This is a fulfilling and challenging career role. The clinical trial market is set to grow aggressively in future and offers ample job opportunities.

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 the broader prospect of rapidly establishing and embracing new operating models and adopting new solutions that allow drawing maximum advantage of what data can offer. 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 the levels of individuals, organisations, and the entire industry. 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. Every company involved in clinical research must maintain TMF documents compliant with appropriate regulations. 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

Clinical monitoring: Risk-based monitoring, remote monitoring, centralized monitoring, hybrid monitoring, decentralized clinical trials, virtual trials, remote project management support, trend and risk analysis, review of key metrics and indicators.

Clinical Trial Management Software, cloud-based operational systems, electronic data capture, electronic trial master file, randomization — IWRS/IVRS or IRT, trial supply management

Patient recruitment and retention services, translation services, imaging vendors, investigator/site payment systems

Patient-Centric technologies: 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.)

Quality of Life Index scales and questionnaires: rating scale development/validation, scale translation/cultural adaptation

Real-World Data, Real World Evidence, Clinical Trial Disclosure, medical writing, training, investigators meeting management, KOL management, patient advocacy, data disclosure, and privacy.

Some of these opportunities may not exist currently in large volumes but may arise in the future upon the implementation of newer technologies

Tips for finding the first job

Have curiosity and interest, and learn as much as possible about clinical research

Join a professional organisation and attend their regional/local events.

Attend industry conferences, job fairs, and expert talks

Network with your school alumni and professionals in the field

Read articles, journals, and magazines, and attend free webinars

Make use of online resources – posts, blogs, podcasts, YouTube content

Be willing to learn new skills and take on new responsibilities

Sharpen communication (written and oral) and other soft skills

Try entry-level jobs — research coordinator/ clinical trial assistant or similar profiles

Seek out internships and volunteer opportunities

Take the best opportunity available to you and work your way up

Explore opportunities at startup companies

Consider building your credentials and industry experience

A clinical research job can be rewarding and highly satisfying. There is an extensive investment in this sector as the level of innovation in the clinical research field is high. As clinical trials continue to deliver data supporting the approval of new drugs and devices, more investments are being made on an international scale, providing much growth in this industry.

(The author is a clinical research professional based in San Francisco)