Solutions Engineer

Flex and Oncology Clinical Research Private Limited; Thiruvananthapuram; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Worldwide Clinical Trials is seeking a capable professional to implement, configure, and maintain systems used in the management and conduct of clinical trials. You will contribute across the software development life cycle to meet business and study specifications.

The role involves ensuring production systems operate reliably, developing data integration, monitoring, and reporting solutions, and collaborating with project teams to define integration processes with vendors.

Qualifications

• Educated to degree level or proven equivalent experience.
• Experience with Java, C/C++, UNIX and .NET technologies.
• 2+ years CRO/clinical systems experience preferred.
• Familiar with clinical trials regulations.

Responsibilities

• Ensure production systems meet SLAs and fix issues per SOPs.
• Develop and maintain clinical study software and integrations.
• Review requirements and assist in design documentation.
• Code, configure, and perform unit testing to deadlines.
• Coordinate with Worldwide departments for system integrations.
• Support auditors and regulatory inspections.

Skills

Communication skills

Attention to detail

Independent worker

Creativity & adaptability

Education

Bachelor's degree in a relevant discipline

Tools

Java

C/C++

UNIX

.NET Framework 4.5

Visual Studio

Job description

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life‑changing therapies to patients around the world. With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research.

SUMMARY:

Implement, configure, and maintain systems used in the management and conduct of clinical trials to meet business and technical or study specifications by contributing at all stages of the software development life cycle.

RESPONSIBILITIES:

• Ensure production systems are functioning to meet their service level agreements by analyzing and resolving issues encountered, including the implementation of bug fixes where required and in alignment with SOPs
• Implement software solutions to meet study requirements, including but not limited to data integration, monitoring and reporting using a variety of platforms, tools, and languages
• Support the Clinical Systems Project Manager and other job functions with the production and review of specifications, plans, reports, study materials and other documentation during the development and support of systems
• Review User Requirements Specifications as appropriate
• Prepare, review and approve study design and integration documentation
• Perform coding and configuration to meet study timelines, fulfill business and technical requirements, and align with SOPs
• Perform formal code reviews to meet study timelines
• Perform informal unit testing to meet study timelines
• Complete Traceability Matrices as required
• Work closely with applicable Worldwide departments to define and coordinate integration processes between systems/vendors
• Interact and effectively communicate with project teams on technical and non-technical terms to determine test and code/configure requirements and acceptance criteria
• Write and execute scripts as required to meet study timelines
• Support Test Analysts during formal testing and/or quality review
• Perform QC checks of manual database edits and other tasks where required
• Assist in the investigation and resolution of issues and/or incidents
• Ensure that all activities are appropriately documented and stored in accordance with the relevant SOP and requirements of the client company
• Fully cooperate with auditors or regulatory authority inspectors before, during and after projects as applicable
• Provide support for users of in-house software.
• Perform other duties as assigned.
• The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

OTHER SKILLS AND ABILITIES:

• Ability to communicate concisely and effectively in both written and spoken English
• Proficient in the use of common office software
• Able to work independently or in a multi-disciplinary team
• High attention to detail
• Able to be creative, adapt to new technologies, concepts and processes, make improvements and solve problems

REQUIREMENTS:

• Educated to degree level in a relevant discipline or be able to demonstrate equivalent experience
• Have a sound working knowledge of at least one of the following: Java and Java Server technologies; Bus integration technologies; UNIX including C, C++ ; relational databases; or the Microsoft toolset including .Net Framework 4.5 , C#, Visual Studio
• 2+ years’ experience in a combination of Contract Research Organization (CRO) experience, IRT study delivery, or clinical systems development desired
• Familiarity with clinical trials, patient safety, data integrity and associated regulations
• Promotion to the next level is not automatic based on years of experience.
• Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

Discover the Difference We love knowing that someone is going to have a better life because of the work we do.

Discover the Difference at Worldwide Clinical Trials.

This is who we are. We’re a team of clinicians, scientists, and researchers who want to make healthcare better. We were founded on an unwavering commitment to authentic, personalized attention. And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than ever. We all came to this industry for different reasons, from different walks of life. If you ask any one of us why we’re here, you’ll get a different answer. And that’s what makes us special.