Talent.com
Senior eClinical Business Lead, IRT/DHT design - UK
Senior eClinical Business Lead, IRT/DHT design - UKParexel • Fresno, CA, US
[error_messages.no_longer_accepting]
Senior eClinical Business Lead, IRT / DHT design - UK

Senior eClinical Business Lead, IRT / DHT design - UK

Parexel • Fresno, CA, US
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Consultant For Randomization And Trial Supply Management (Rtsm) And Digital Health Technology (Dht) Systems

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.

Picture yourself at Parexel :

The role provides consultation on the Randomization and Trial Supply Management (RTSM) and Digital Health Technology (DHT e.g., eCOA, eConsent) system design, analysing study protocols and collaborating with stakeholders to create user requirements to meet the needs of the study. This individual is responsible for identifying and mitigating risks related to RTSM and DHT design and ensuring that the overall deliverables align with internal and external client expectations.

In addition, this role provides oversight of and conducting of User Acceptance Testing (UAT) on RTSM and Digital Health Technology (e.g., eCOA, eConsent) systems. This individual ensures project management and technical skills are utilized to timely manage UAT for projects, meeting budget and quality standards.

What you'll do at Parexel :

Project Delivery

  • Provide consultation to Project Leaders and other study team members on RTSM and DHT study design.
  • Analyse protocols and collaborate with all stakeholders to create and review User Requirements and ensure they meet the needs of the study design.
  • Identify and mitigate any risks related to RTSM and DHT study design.
  • Translate complex RTSM and DHT requirement descriptions into language that can be understood by study team to aid in their decision making and understanding of project functionality.
  • Understand the various integrations that can interface with RTSM and DHT, and proactively help identify any potential integration user requirements issues.
  • Work closely with UAT Leads.
  • Stay current on RTSM and DHT technology and relevant clinical trial process developments in the industry and requirements within Parexel.
  • Manage quality control and timely delivery of project deliverables and appropriate remedial action.

Client Management

  • Interact with external clients as needed for discussion on RTSM and DHT design and protocol elements.
  • Demonstrate a proactive approach to providing solutions in a timely manner.
  • General Admin

  • Maintain a working knowledge of applicable ICH Guidelines and Good Clinical Practices.
  • Complete routine administrative tasks in a timely manner (e.g., timesheets, training) and in compliance with relevant guidelines.
  • Ideal candidate will possess :

  • At least 12 months experience in IRT / RTSM and / or Digital Health Technology system delivery.
  • Ability to develop detailed awareness of Clinical Research Services, external vendor software and tools with practical knowledge of how these applications work and provide efficiency to operations.
  • Experience in clinical trial systems (e.g, CTMS, EDMS, EDC, IRT, reporting tools) and in configuration of these systems.
  • Ability to work autonomously.
  • Global virtual team coordination experience for trial technology set-up.
  • Good project management skills.
  • Excellent verbal and written communication skills.
  • Fluent English.
  • Strong customer focus.
  • Knowledge of SOPs / Guidelines / System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.
  • Awareness / experience in the needs and use of data standards in clinical trial environment; if possible, knowledge of data standards such as CDISC SDTM.
  • In depth understanding and experience of clinical trial processes.
  • Demonstrated adeptness in learning new systems and function in an evolving technical environment.
  • [job_alerts.create_a_job]

    Design Lead • Fresno, CA, US

    [internal_linking.similar_jobs]
    Clinical Director

    Clinical Director

    Telecare Corporation • Sanger, CA, United States
    [job_card.full_time]
    Clinical Director - Sanger Place.They made it easier for me to live, breathe, eat, and stay clean.Without them, I'd be waiting somewhere, waiting for someone to give me a chance to live.Client from...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Director of Networks, Unified Communications, and Learning Spaces

    Senior Director of Networks, Unified Communications, and Learning Spaces

    California State University - Fresno • Fresno, CA, United States
    [job_card.full_time]
    Senior Director of Networks, Unified Communications, and Learning Spaces.Bargaining Unit : MPP, Appointment Type : At-Will, Time Basis : Full Time, Job Search Category / Discipline : Information Systems ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    National Business Development Director - Oncology & Urology

    National Business Development Director - Oncology & Urology

    McKesson • Fresno, CA, US
    [job_card.full_time]
    Oncology & Urology National Business Development Director.McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, pr...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Solutions Design Specialist

    Solutions Design Specialist

    Meteor Education • Clovis, CA, US
    [job_card.full_time]
    [filters_job_card.quick_apply]
    JOB TITLE : Solution Design Specialist.REPORTS TO : VP of Sales, West Region.LOCATION : Fresno, CA; Sanger, CA; Clovis, CA. Fowler, CA.COMPENSATION : $70K-$75K base +commission.At Meteor, integrity and...[show_more]
    [last_updated.last_updated_30]
    Clinical Supervisor (BCBA)

    Clinical Supervisor (BCBA)

    FirstSteps for Kids, Inc. • Fresno, CA, US
    [job_card.full_time]
    The FirstSteps Program Director .At FirstSteps, we recognize the transformative impact of exceptional clinical leadership. Our Program Directors exemplify these qualities, ensuring that our com...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Clinical Sales Representative

    Clinical Sales Representative

    Cranial Technologies • Fresno, CA, US
    [job_card.full_time]
    Cranial Technologies is the only company in the world completely dedicated to researching, diagnosing, and treating plagiocephaly (commonly called flat head syndrome). With over 300,000 babies succe...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Side Hustle Project Lead

    Side Hustle Project Lead

    Finance Buzz • Lemoore, California, US
    [job_card.full_time] +1
    We’re offering a role for someone who wants to lead their own side-income project in their spare time.You’ll explore various proven side hustles, select the ones that fit your lifestyle, and run th...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Project Manager ITS 1

    Project Manager ITS 1

    Community Medical Centers • Fresno, CA, US
    [job_card.full_time]
    Consecutively recognized as a top employer by Forbes.Vacation time starts building on Day 1, and builds with your seniority. Free parking and electric charging.Great food options with on-demand orde...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Interim Director, Oncology

    Interim Director, Oncology

    HCT Healthcare Transformation • Fresno, CA, US
    [job_card.temporary]
    HCT seeks an experienced professional to serve as the Interim Director, Oncology at outpatient facility in California.Education : BSN degree required, MSN preferred. Experience : 12 years of recent an...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Principle - Data Architect (Dicom / Medical Imaging)

    Principle - Data Architect (Dicom / Medical Imaging)

    CitiusTech • Fresno, CA, US
    [job_card.full_time]
    Data Architect (Medical Imaging / Dicom).With over 8,500 healthcare technology professionals worldwide, CitiusTech powers healthcare digital innovation, business transformation, and industry-wide con...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Occupational Therapist (OT) - Neuro Rehab

    Occupational Therapist (OT) - Neuro Rehab

    Nealy Pierce, LLC • Fresno, CA, United States
    [job_card.full_time] +1
    Full-time permanent Acute Rehab position.See 5 patients per day on average with a 75% productivity standard.Mentorship and training from a strong team of Occupational Therapist.Paid Time Off (PTO) ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Healthcare Business Development Specialist

    Healthcare Business Development Specialist

    My Diabetes Tutor, Inc. • Fresno, California, United States, 93650
    [job_card.full_time]
    At My Diabetes Tutor, we're on a mission to empower people living with diabetes to take control of their health through expert, personalized, virtual care. Our team is dedicated to improving outcome...[show_more]
    [last_updated.last_updated_30]
    Clinical Director (Behavioral Health) Must be licensed(LCSW, LPC, LMFT, LCPC, or equivalent)

    Clinical Director (Behavioral Health) Must be licensed(LCSW, LPC, LMFT, LCPC, or equivalent)

    Recruit With Care • Fresno, CA, US
    [job_card.full_time]
    As Clinical Director, you'll lead the delivery of our behavioral health programs within community health centers, ensuring exceptional clinical care and strong partnerships with our FQHC (Federally...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Research & Development Business Manager

    Research & Development Business Manager

    Helena Agri-Enterprises, LLC • Lemoore, CA, United States
    [job_card.full_time]
    Helena Agri-Enterprises, LLC is a leading full-service agronomic solutions provider that's been in business since 1957.Our first location was in West Helena, Arkansas hence the name "Helena".We now...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Technical Director - Remote

    Technical Director - Remote

    INDI Staffing Services • Fresno, CA, United States
    [filters.remote]
    [job_card.full_time]
    At INDI, we're passionate about empowering individuals and businesses worldwide.Our cutting-edge recruiters connect leading companies with top talent, fostering a dynamic environment where innovati...[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    Clinical Risk Manager

    Clinical Risk Manager

    CareAgents by K&B • Fresno, CA, US
    [job_card.full_time]
    The Clinical Risk Manager is a dynamic professional who leverages their extensive risk management expertise to enhance resident safety and reduce the risk of future litigation, improving operationa...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Manager, Design Practice

    Manager, Design Practice

    California Staffing • Fresno, CA, US
    [job_card.full_time]
    CDM Smith is seeking a Design Practice Manager to join our Digital Engineering Solutions team.This individual will lead the Design Practice group, helping to drive the firm's digital transformation...[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    Clinical Marketing Liaison

    Clinical Marketing Liaison

    Fremont Hospital - Behavioral Health • Fresno, CA, US
    [job_card.full_time]
    Come join our team and love what you do! We are currently hiring a Full Time.The Clinical Marketing Liaison plays a key role in building and maintaining relationships with community partners, refer...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]