Solutions Analyst

Flex and Oncology Clinical Research Private Limited; Thiruvananthapuram; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Worldwide Clinical Trials in India seeks a senior analyst to bridge business needs and clinical systems. You will analyze requirements, document specifications, and help configure integrations to meet study requirements. You will mentor teams and ensure quality in system implementations across projects.

The role emphasizes collaboration with stakeholders, ensuring regulatory alignment and effective communication of business needs to technical teams.

Qualifications

• 5+ years’ experience in conduct of clinical trials and related computer systems
• Experience analysing user or business requirements and documenting them
• Familiarity with process, data and system modeling techniques
• Understanding of application and integration infrastructures for business goals
• Familiarity with GxP regulatory requirements

Responsibilities

• Provide technical input to multi-disciplinary project teams from discovery to retirement
• Prepare analysis input, documentation and support for business cases
• Assist in selection and implementation of external systems and services
• Support adoption of new solutions with technical guidance
• Create and maintain business, configuration and technical specifications

Skills

English communication

Requirements gathering

Stakeholder management

Presentation skills

Mentoring others

Detail orientation

Education

Degree or equivalent experience

Job description

WHO WE ARE

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

WHY WORLDWIDE

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

SUMMARY

Applies both business knowledge and technical expertise to support the implementation of clinical systems for business stakeholders to meet cross-organizational business needs as well as the configuration of systems to meet study requirements by providing analysis, **recommendation, documentation, and delivery of technical solutions.

RESPONSIBILITIES

• Tasks may include but are not limited to:
• Provide technical input to multi-disciplined project teams tasked by senior executives to address particular business needs during all project phases from discovery to retirement
• Provide analysis input, technical documentation, and other support needed to build a business case for strategic initiatives supporting departments across the corporation
• Apply both business as well as technical expertise to assist in the selection and implementation of external systems and services
• Provide technical support to drive adoption of new solutions
• Produce and maintain business requirement, configuration requirement, and technical specification documentation for clinical systems as well as for study-specific software implementations or configurations, such as IRT or cross-system integrations
• Elicit stakeholders’ underlying business needs and transform them into documented business requirements, via multiple and various techniques include: interviewing stakeholders and users, applying business knowledge and insight, researching industry best practices and emerging technology, and considering options beyond stakeholders’ suggested solutions
• Manage the requirements change process to ensure traceability and in alignment with departmental processes and tools
• Ensure effective communication of business and functional requirements to the project team and stakeholders
• Provide expertise and mentorship to the project team and stakeholders in the use of new systems
• Configure systems and integrations between systems to meet the needs of documented requirements at a system or study level, in alignment with relevant SOPs and work practices
• Provide quality control review of configurations implemented by others to verify alignment with SOPs and requirements
• Support or execute the design, implementation, and quality control review of reports using business intelligence tools
• 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
• Highly effective in the use of interviews to uncover fundamental business requirements
• Strong presentation skills
• Able to work with all levels of stakeholders including senior executives
• Ability to quickly become proficient in new systems, including the ability to represent system capabilities via demonstration
• Self-motivated individual who can positively contribute to a team environment
• High attention to detail
• Highly creative, and able to adapt to new technologies, concepts and processes, and to make improvements and solve problems
• Ability to mentor others in new technologies and best practices

REQUIREMENTS

• Educated to degree level in a relevant discipline or able to demonstrate equivalent work experience
• Experience of analysing user or business requirements and documenting them
• Experience with various modelling techniques such as process modeling, data modeling, system modeling
• 5+ years’ experience in the conduct of clinical trials and an understanding of the computer systems utilized in support of clinical trials or in business systems analysis for medium to large back office systems
• Understanding of application and integration infrastructures and how they can and should be utilized to achieve business goals
• Familiarity with user experience concepts and best practices
• Familiarity with risk assessment and mitigation planning strategies
• Familiarity with GxP regulatory requirements
• Understanding of IRT design and just-in-time drug supply desired
• Familiarity with clinical trials, patient safety, data integrity and associated regulations desired

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

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful.

We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity.

We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

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.