CLINICAL RESEARCH AND CAREER PATH FOR FRESHERS

In this world of rigorous competition, we’re supposed to either blend in or know exactly what to do. It is quite overwhelming that the social media feed only talks about success stories, job promotions and significant achievements.

Meanwhile, you’re stuck wondering what to do next. While you may be thinking that being confused is a bad thing, It actually helps you explore and consider unknown sectors you would never know otherwise.. When you have a problem, all you want is to fix the problem and move on, right? Same goes for your career and here I am to help you with my two cents. .

Why You Are Confused About Your Career?

Everybody is confused at some point and it can be in many forms. It can be to choose between two jobs or choosing a career or switching a career. Confusion can only happen if you care. You can create anything you want.

Now, let me help you:

➢ Consult an expert. Look around you. Do you see anyone who has the life or the career you want? . You can research about them online and check their profile history. You will notice not everybody has a straight career path. One has to do many odd jobs or one can just be lucky. You can talk to the interested people to know their journeys, learnings and unlearnings.

➢ Get a coach. It could be the same person as the one who inspires you. Whoever it is, they need to have a great understanding of the terrain you are in and have a sincere desire to serve your best interest without judgment.

Careers in Clinical Research field

➢ Pharmacovigilance - Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drugrelated problem. This is an excellent employment option for pharmacy graduates.

➢ Medical Coding - Medical coding is not a simple data-entry profession. It requires certification to gain knowledge of medical terminologies, pharmacology, and anatomy for one to be able to comprehend patient records and charts. Medical coders from the clinical data management team process the medical terms and perform medical coding. Medical coding is performed to categorize the medical terms reported appropriately so that they can be analyzed/reviewed.

➢ SAS Programming - Responsible for building programs to create SAS datasets from the clinical database, external data sources, and other sources while following the clinical study's protocol or statistical plans. Base SAS certification is usually considered helpful in securing an entry-level job in analytics but make sure you have good programming skills.

➢ Biostatistics - Statistical analysis is an important part of clinical trials because it allows researchers to determine whether their results were meaningful on a statistical level. Clinical biostatisticians usually hold advanced degrees in biostatistics.

➢ Clinical Research Associate - Working as a clinical research associate (CRA) is a very rewarding career. Responsibilities of a CRA include helping to set up a clinical trial and then monitoring trial protocol once a study is up and running. CRAs are required to have either a science degree or a nursing degree. A life science degree, such as in biology, pharmacy, or biochemistry, is the most useful degree to have.

What is Clinical Data Management ?

Clinical data management (CDM) is a critical phase in clinical research, which leads to the generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management assures collection, integration, and availability of data at appropriate quality and cost. Clinical data management plays an essential role in the data collection phase of clinical research.

The process of collecting and managing research data is done in accordance with regulatory standards to obtain quality information that is complete and error-free; the goal is to gather as much of such data for analysis as possible. The field of clinical data management (CDM) has come about due to demands from both the pharmaceutical industry and the regulatory authorities. As the drive to “fast-track” the development of pharmaceutical products continues to accelerate, regulatory entities have responded by requiring qualityassurance standards be met in collecting the data used in the drug evaluation process.

Requirements or Basic Qualification for CDM

Clinical data managers have a variety of educational backgrounds and professional experience:

➢ Minimum of bachelor’s or master’s degree in life sciences (e.g., biology, cognitive science, ecology, microbiology, immunology, molecular genetics, neuroscience, physiology, psychobiology, psychology) or clinical research management

➢ Post-master’s certificate in clinical data management or clinical trials in medical device and drug development

➢ Master of Science in clinical research organization and management

➢ Certification in Clinical data management, health informatics, or biometrics

➢ Post-bachelor diploma courses in Clinical Research and Clinical data management

Now, let us see what the basic Skills you should have:

➢ Knowledge of clinical trials/ drug development process.

➢ You will be working in a highly regulated environment and should have an expert understanding of GCP, ICH, and other relevant regulatory requirements to ensure that studies are conducted compliantly.

➢ Clinical data personnel are required to be detail-oriented as the success of the clinical trial depends directly on the team’s precise collection of data.

➢ Good decision-makers to decide on data collection methods and data collection suppliers.

➢ Once you are on-job, Clinical data managers also need to be critical problem solvers, because unforeseen issues are bound to occur during the execution of a clinical trial.

Job Titles in Clinical Data Management

➢ Data entry associate - Tracks the receipt of CRF pages and enters data into a database.

➢ Clinical Data Associate - Clinical Data Associates are accountable for proper capturing, recording, documenting of clinical research data for clinical study and validation. Clinical Data Associates must make sure that studies or protocols are completed consistently.

➢ Clinical Data Coordinator or Clinical Data Specialist - Conduct data management tasks for data review, writing and clearing data clarifications. Designs the CRF, prepares the filling instructions, develop protocols and other important documents involved in CDM. Inform Data Manager on project status and potential problems regularly. Review CRFs and electronic clinical edit programs and generate and resolve data queries. Review clinical sites and edit listing and checks and generate queries and update databases. Identify and comply with working instructions and core operating procedures. Handle external vendor Clinical Data Management System to ensure vendor quality service on budget and time.

➢ Database programmer or designer – DB Programmer performs CRF annotation, creates the study database, enables data validation, designs data entry screens and performs edit checks using dummy data.

➢ Lead Data Manager - The senior clinical data manager is typically responsible for managing all aspects of clinical data management activities. This often includes tracking the completeness and validity of the clinical database, devising the data management plan, and participating in the creation and subsequent management of standard operating procedures. A senior clinical data manager is often required to have several years of clinical data management experience, and an undergraduate degree in a related field.

➢ Clinical Data Manager - Clinical Data Managers monitor work productivity or quality to ensure compliance with standard operating procedures. They process clinical data, including receipt, entry, verification, or filing of information. Supervise the work of data management project staff and handle a team of 10-15 or more. Generate data queries, based on validation checks or errors and omissions identified during data entry, to resolve identified problems. Analyze clinical data using appropriate statistical tools. Design forms for receiving, processing, or tracking data.

Tips to Create the Best Resume

➢ Write a crisp and professional resume to get interview calls. Your resume is your first interaction with an employer that can help you highlight your skills and strengths, and thereby, catch recruiters’ attention.

➢ Guide the recruiter to the conclusion that you are the best candidate for the clinical data management job. It is actually very simple. Tailor your resume by picking relevant responsibilities and add your accomplishments. This way, you can position yourself in the best way to get hired.

➢ Craft your perfect resume by picking job responsibilities written by professional recruiters.

➢ Pick from the thousands of curated job responsibilities used by the leading companies. Tailor your resume by selecting wording that best fits for each job you apply.

➢ Readability - Succinct and to the point i.e. your CV should be easy to read and keep your CV short and simple.

➢ Profile Summary - profile summary means, read on. It is a crisp pitch to recruiters that talks more precisely about you. A well-written profile summary convinces recruiters to scroll down your resume and scan further information. A professional profile or career summary for fresher should be precise and highlight the best in you.

Mistakes to Avoid

➢ Ensure to have a good Cover letter along with the resume

➢ Make your resume crisp and relevant. Too lengthy resumes are not useful.

➢ Never lie and provide false information.

➢ Always check grammatical errors.

➢ Avoid typo errors. This makes you look careless.

Alright, my friend, I’m excited for you. Hope you enjoyed reading this article and thanks for sparing your little time. It’s time to step up and lead yourself into the future. In the end, no matter what path you take, you are still creating your life. Have fun with it!

“It is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change”

All the best!