Meet Xin Ni: Clinical Data Analyst I (Malaysia)

Please introduce yourself.

Greetings!

I am a fresh graduate with a bachelor’s degree in biomedical science. I joined Parexel as the first batch of Intern Clinical Data Analyst in Malaysia in February 2023. After a stint of 5 months, I was shortlisted and hired as a permanent Clinical Data Analyst I in July 2023.

What is it like to work as a Clinical Data Analyst? Can kindly help to introduce the daily job?

As a Clinical Data Analyst, we carry out our duty as a guardian to the data of clinical trials.

In general, our daily routine involves dataset review to ensure all collected data is complete, correct, and consistent as per protocol requirement. We also perform data reconciliation by comparing data from a database with another platform. We are required to raise query or ask relevant question as to why a mismatch or a discrepancy is there.

Meanwhile, we have to generate specific reports which provide us detailed information on study progress based on study requirement.

What are the positions does Data Management team collaborates with most frequently?

In Data Management team, we closely collaborate with Clinical Database Programmer (CDP) and Clinical Data Engineer (CDE) to develop a comprehensive database and output various reports for data cleaning.

We also communicate frequently with Clinical Research Associate (CRA) to seek for their assistance in moderating our communication with investigator or site personnel.

Moreover, we collaborate with Medical Monitor (MM) to validate medical-related data. From my perspective, mutual support exists among us across various departments in providing the best services to our clients and all stakeholders.

What kind of advice you’d give to people who’d like to join Data Management team?

If you are interested in joining Data Management team, I would suggest to evaluate if you possess the characteristics and interest in this field. Below are key behaviors and qualities which are crucial:

• Sense of ownership: Taking responsibility of your own assignment
• Attention to detail
• Keep and open mind and willing to learn new knowledge
• Quality mindset: Everything we do, we prioritize patient safety first

What do you enjoy outside of work? What is something most people don't know about you that would surprise them?

During non-business day, I enjoy organizing and volunteering in charity events, and I feel grateful when contributing and learning from the society. I love to explore everything, i.e., new place, new skills, new people, new experience etc., and even if I am on my own. Most people were amazed when I was going for a work exchange program alone.

If you were to introduce your job to a friend that does not know CRO, how would you introduce CRO to them?

CRO stands for Clinical or Contract Research Organization. In general, CRO is a specialized service provider to assist pharmaceutical, biotechnology, and medical device companies in conducting clinical trial or research.

Clinical research is a medical or healthcare study that involves human participants, and it is crucial for evaluating safety and effectiveness of medical interventions. Prior to the new treatments or therapies being push into the market, clinical trial is a mandatory process in order to gain the regulatory approval from Food and Drug Administration (FDA).

However, clinical trial is a complex and time-consuming process which requires a variety of procedures and involves many parties such as regulatory agencies, investigators, patients etc. Therefore, by partnering with CRO, it enables the pharmaceutical, biotechnology, and medical device companies to keep focusing on their expertise in research and development (R&D) area.

How would you introduce the job of Data Management team? Can you help to introduce how does Data Management team functions in the clinical research cycle?

There are three main phases in Data Management for clinical trial, which are study start-up, conduct, and close-out phases.

During start-up phase, Data Management team is responsible for preparing data management plan as well as database design and development which will be used to collect data. When study is ongoing, we will perform data validation and data cleaning to ensure all data collected throughout the clinical trial is complete, correct and consistent. Lastly, the database lock, electronic archival, database transfer will be executed during the study close-out phase.

Data Management team will ensure all procedures and documentations during the three phases are adhered to the study protocol, eCRF completion guidelines (CCG) and regulatory requirements.

What do you think is the most attractive part of Parexel and CRO industry? 

Personally, the most attractive part of Parexel is the chance to participate in projects across multi-nations.

Throughout the collaboration, we may discover different cultures and working styles for other countries. While being in CRO industry, we often collaborate with different departments, and we are able to learn about some knowledge from other departments as well. I feel grateful to have Parexel colleagues who are always happy to share their experience and knowledge.

Can you share the training provided at Parexel? 

The training provided at Parexel is comprehensive and well-designed for employees from all experience levels. The general company resource training helps new employees to acknowledge the organization background, policies, and regulations.

Meanwhile, position- or project-specific training enables the employees to acquire the skills to perform the specific tasks by adhering to the standard operation procedures (SOPs).

Apart from that, training also will be provided when there is any updates or amendments based on the previous training. Therefore, all employees could receive the latest information and all procedures are standardized within our organization.

Please share how you use Parexel benefit and what are the best part of it.

I think the best part of Parexel is the working flexibility as we could always work at our preferences, providing that we manage to complete the assignments within the timeline. We are also able to be out of office if there is any emergency case due to the working flexibility and sufficient backup from our teams.