Senior eClinical Business Lead, IRT & DHT Design Consultant

Reposted 11 Days Ago
Be an Early Applicant
Hiring Remotely in Hyderabad, Telangana, IND
In-Office or Remote
Senior level
Pharmaceutical
The Role
Provide expert consultation on RTSM and DHT study design, analyze protocols, develop and review user requirements, identify and mitigate design risks, manage integrations and UAT coordination, ensure quality and timely delivery, interact with clients, and maintain compliance with ICH/GCP and industry data standards.
Summary Generated by Built In

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

We are seeking a Senior eClinical Business Lead, IRT and DHT Design Consultant to join our team. As a strategic advisor in clinical technology, you will support clinical research activities that advance new treatments for patients. This position plays a key role in RTSM and DHT study design, requirements analysis, stakeholder collaboration, and clinical trial optimization. You will collaborate with cross-functional teams, follow industry-standard processes, and contribute to study operations from planning through closeout. Responsibilities include providing expert consultation on digital health technology implementation, translating complex requirements into actionable solutions, and ensuring seamless integration across clinical trial systems.
 

You will join a fast-paced, growth-oriented environment focused on making a meaningful impact through advancing clinical trial technology, improving study efficiency, and enhancing patient engagement. With diverse teams and continuous learning opportunities, this role offers the chance to explore career paths and expand expertise across clinical research and digital health innovation.

Key Responsibilities:

  • Provide expert consultation to project leaders and study teams on RTSM and DHT study design, requirements gathering, and system configuration

  • Analyze protocols and collaborate with stakeholders to develop, review, and validate user requirements that align with study design objectives and regulatory standards

  • Identify, assess, and mitigate risks related to RTSM and DHT implementation, ensuring compliance with clinical trial processes and data integrity standards

  • Translate complex technical and business requirements into clear, actionable guidance for study teams and system users to facilitate informed decision-making

  • Evaluate system integrations and proactively identify potential issues with third-party interfaces, data flows, and user requirements to ensure seamless functionality

  • Partner with UAT leads to design, execute, and validate testing protocols, ensuring systems meet defined requirements and business objectives

  • Stay current on emerging RTSM and DHT technologies, industry best practices, and regulatory developments to drive continuous improvement and innovation

  • Manage quality assurance and timely delivery of project deliverables while implementing corrective actions to maintain excellence

  • Interact with external clients to discuss RTSM and DHT design considerations, protocol requirements, and implementation strategies

  • Demonstrate proactive problem-solving and deliver timely, effective solutions to client challenges and technical issues

You will thrive in this role if you bring:

  • Deep expertise in RTSM and DHT systems, clinical trial design, and requirements management

  • Strong analytical and problem-solving abilities with the capacity to work independently and escalate appropriately

  • Experience working in clinical research, healthcare, or a regulated environment

  • Exceptional ability to collaborate across teams and communicate complex concepts clearly to diverse audiences

  • Patient-focused mindset with strong attention to detail and commitment to data integrity

  • Comfortable working with RTSM platforms, digital health technology (DHT) solutions, and clinical trial management systems (CTMS).

Required Qualifications:

  • Bachelor's degree in Life Sciences, Computer Science, or a related field, or equivalent professional experience

  • 5+ years of experience in building RTSM and/or DHT clinical trial systems, developing user requirements, and managing requirements gathering, configuration, design, and user acceptance testing

  • Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes

  • Excellent technical and data standards knowledge with proven experience applying data standards in clinical trial environments

  • Demonstrated ability to create and explain business processes and train others on implementation

  • Strong communication, organization, and problem-solving skills

Preferred Qualifications:

  • Knowledge of industry standards such as CDISC SDTM and other data standards relevant to clinical trials

  • Experience with eCOA or ePRO systems and digital health technology platforms

  • Proven track record of conducting root cause analysis and driving process improvement initiatives

  • Demonstrated client-focused approach with ability to build and maintain strong client relationships

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!

Skills Required

  • 5+ years building RTSM and/or DHT clinical trial systems and developing user requirements
  • Excellent technical and data standards experience
  • Proven awareness and experience with data standards in clinical trials
  • Knowledge of CDISC SDTM
  • Ability to create and explain business processes and train others
  • Strong analytical and problem-solving skills, including root cause analysis
  • Ability to resolve issues independently and escalate appropriately
  • Client-focused with ability to create and maintain client trust
  • Knowledgeable in ICH Guidelines and Good Clinical Practice (GCP)
  • Excellent interpersonal, verbal, and written communication skills
  • Expert understanding of clinical technology, RTSM design, and system requirements
  • eCOA and ePRO experience
  • Bachelor's degree in Life Sciences, Computer Science, or related field, or equivalent experience

Parexel Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.

  • Healthcare Strength Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
  • Retirement Support Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
  • Leave & Time Off Breadth Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.

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The Company
HQ: Raleigh, NC
20,524 Employees

What We Do

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

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