Qureos Mentor

The Emmes Company, LLC

<div>Overview:
<div><b>
Senior Clinical Research Associate</b></div><div></div><div><b><br>
US Remote</b></div><div></div><div><br>
Emmes Group: Building a better future for us all.</div><div></div><div><br>
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.</div><div></div><div><br>
We believe the work we do will have a direct impact on patients&rsquo; lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We&rsquo;re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!</div><div></div><div><b><br>
Primary Purpose</b></div><div></div><div><br>
The Senior Clinical Research Associate (CRA) is responsible for monitoring clinical study sites either on-site at investigative sites or remotely to ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH GCP, and all applicable regulatory requirements. The CRA will conduct monitoring visits and activities in accordance with Emmes SOPs, applicable regulations, and ICH GCP.
</div>Responsibilities:
<ul><li>Under minimal supervision of the project CRA staff oversight lead (i.e. Clinical Study Manager, Lead CRA, Project Manager, etc.) independently schedules and conducts remote and on-site monitoring visits such as qualification/pre-study visits, site initiation visits, interim/routine monitoring visits, closeout visits, and for-cause visits.</li><li>
As part of the site visits, independently conducts Informed Consent (ICF) review, source data verification/source document review, review for compliance with required reporting/tracking of adverse events and protocol deviations, investigator site file review, laboratory tour and specimen storage assessment, pharmacy/Investigational Product (IP)/Investigational Device (ID) storage location tour and storage condition assessment, IP/ID accountability, facilities tours, and other activities per the site monitoring plan under minimal direction from the project CRA staff oversight lead.</li><li>
Documents observations and monitoring activities in a site visit report at the conclusion of the visit with minimal feedback by the report reviewer.</li><li>
Facilitates and oversees Action Item resolution post visit.</li><li>
Helps to ensure that clinical sites are conducting the study in compliance with protocol/clinical investigational plan, SOPs, ICH GCP, and other applicable regulations.</li><li>
Provides training and retraining to site staff including protocol, GCP/GDP, and other training under direction from the project CRA staff oversight lead.</li><li>
Identifies areas requiring follow-up and improvement at each clinical study site and reports findings to project CRA staff oversight lead.</li><li>
Ensures all visits are conducted according to country regulations, ICH GCP, and company standard operating procedures.</li><li>
Serves as point of contact for study site personnel to answer questions and resolve study related issues under the direction of the project CRA staff oversight lead.</li><li>
May assist with the development and/or review of study-related materials including protocols, informed consent forms, monitoring plan, monitoring documents, etc.</li><li>
Prepares for and attends project team meetings and provides updates on project status and site-specific performance.</li><li>
Works collaboratively and effectively in a project team environment including internal and external colleagues to meet project objectives and timelines.</li><li>
Participates in Investigator Meetings or other client meetings as needed.</li><li>
Assists with filing and archiving of study documents.</li><li>
Assists in preparing sites for audits and may provide support and cooperation during audits/inspections (including translation to Auditor if needed).</li><li>
May assist with coordination of clinical study supplies.</li><li>
May assist with submission of applications/notifications to Institutional Review Board (IRB)/Ethics Committee (EC)/Regulatory Authority.</li><li>
May assist with site recruitment oversight activities such as developing focused patient recruitment strategies and action plans.</li><li>
Performs site management activities as required.</li><li>
Other duties as assigned.</li></ul>
Qualifications:
<ul><li>Bachelor&rsquo;s degree (scientific discipline preferred) or equivalent work experience</li><li>
At least 4-5 years of relevant monitoring experience (on-site and remote)</li><li>
Proficient with MS Office Suite</li><li>
Excellent computer and organizational skills</li><li>
Exceptional level of attention to detail required.</li><li>
Ability to work on varying projects and exercise critical thinking with minimal oversight</li><li>
Self-starter who can work remotely and a team player who can work cross functionally with minimal oversight.</li><li>
Expertise in clinical research operations, including interpretation and implementation of country regulations/ICH guidelines, as required per their role as a CRA.</li><li>
Excellent organizational, interpersonal, and communication skills (both oral and written).</li><li>
Demonstrated problem-solving skills, self-motivated, and adaptable to a dynamic environment.</li><li>
Expertise in prioritization, problem-solving, organization, critical thinking, decision-making, time management, and planning activities.</li><li>
Ability to collaborate with internal and external colleagues and work well in a team-oriented setting.</li></ul><div></div><div><i><br>
Why work at Emmes?</i></div><div></div><div><br>
At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our <b>Emmes Cares</b> community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:</div><div></div><div><div><ul><li><b><br>
Flexible Approved Time Off</b></li></ul><p></p><ul><li><b><br>
Tuition Reimbursement</b></li></ul><p></p><ul><li><b><br>
401k Retirement Plan</b></li></ul></div><div><ul><li><b><br>
Work From Home Anywhere in the US</b></li></ul><p></p><ul><li><b><br>
Maternal/Paternal Leave</b></li></ul><p></p><ul><li><b><br>
Casual Dress Code &amp; Work Environment</b></li></ul></div></div><div></div><div><b><br>
CONNECT WITH US!</b></div><div><i>
Follow us on Twitter - @EmmesCRO</i></div><div><i>
Find us on LinkedIn - Emmes</i></div><div></div><div><i><br>
The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.</i></div><div></div><div><br>
#LI-Remote</div></div>

Senior Clinical Research Associate

<div>Overview:
<div><b>
Statistical Programmer</b></div><div></div><div><b><br>
US Remote</b></div><div></div><div><br>
Emmes Group: Building a better future for us all.</div><div></div><div><br>
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.</div><div></div><div><br>
We believe the work we do will have a direct impact on patients&rsquo; lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We&rsquo;re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!</div><div></div><div><b><br>
Primary Purpose</b></div><div></div><p><br>
The Statistical Programmer provides robust statistical programming support for multiple clinical projects using SAS to deliver key regulatory-compliant output. Key responsibilities include developing programming documentation, writing efficient code, and staying updated on statistical programming techniques. This role also provides project updates to management while performing assigned duties and may present internally on statistical programming topics.</p>
Responsibilities:
<ul><li>Provides statistical programming support for multiple clinical research study projects or study teams.</li><li>
Provides strong statistical programming support and validation with SAS (Base and Macros).</li><li>
Ensures that sound methodologies are adopted by broadening knowledge of programming techniques required for clinical trials research which involve either CDISC standards and analysis data sets or production of standard and custom tables listings and figures.</li><li>
Provides key deliverables based on regulatory requirements of regulatory requirements for clinical research E-submissions and/or study requirements for Sponsor, Regulatory, Investigator or Safety review meetings.</li><li>
Supports development of programming documentation and annotations including specifications, adhering to relevant Standard Operating Procedures.</li><li>
Writes well-documented, efficient and high-quality code, conducts code review and programming validation as needed.</li><li>
Broadens knowledge of current statistical programming techniques to ensure the adoption of sound methodologies.</li><li>
May present statistical programming topics internally.</li><li>
Provides project updates to appropriate project management or department management staff.</li><li>
Other duties as assigned.</li></ul>
Qualifications:
<ul><li>A bachelor's degree plus 2 years Statistical programming experience as a CDISC/TLF Statistical programmer in Pharmaceutical/CRO environment, or master's/doctoral degree with no experience, education in a scientific discipline preferred.</li><li>
Base SAS Certification.</li><li>
Understanding of GCP principles and other regulatory standards (e.g. FDA, EMA, and ICH guidance and recommendations) in Clinical Research.</li><li>
Good analytical skills with the ability to process scientific and medical data.</li><li>
Ability to manage multiple tasks and priorities.</li><li>
Ability to work independently as well as in a team environment.</li><li>
Ability to prioritize, problem-solve, organize, and make decisions.</li><li>
Ability articulate programming and technical concepts through written and oral communication.</li><li>
Strong communication, interpersonal and organization skills.</li><li>
Self-motivated, proactive and detail oriented.</li><li>
Strong statistical programming skills in SAS, familiarity with R, Python or other relevant statistical software considered beneficial.</li></ul><div></div><div><i><br>
Why work at Emmes?</i></div><div></div><div><br>
At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our <b>Emmes Cares</b> community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:</div><div></div><div><div><ul><li><b><br>
Flexible Approved Time Off</b></li></ul><p></p><ul><li><b><br>
Tuition Reimbursement</b></li></ul><p></p><ul><li><b><br>
401k Retirement Plan</b></li></ul></div><div><ul><li><b><br>
Work From Home Anywhere in the US</b></li></ul><p></p><ul><li><b><br>
Maternal/Paternal Leave</b></li></ul><p></p><ul><li><b><br>
Casual Dress Code &amp; Work Environment</b></li></ul></div></div><div></div><div><b><br>
CONNECT WITH US!</b></div><div><i>
Follow us on Twitter - @EmmesCRO</i></div><div><i>
Find us on LinkedIn - Emmes</i></div><div></div><div><i><br>
The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.</i></div><div></div><div><br>
#LI-Remote</div></div>

Statistical Programmer

<div>Overview:
<div>
Emmes Group: Building a better future for us all.</div><div></div><div><br>
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.</div><div></div><div><br>
We believe the work we do will have a direct impact on patients&rsquo; lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We&rsquo;re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!</div><div></div><div><b><br>
Primary Purpose</b></div><div></div><p><br>
We are seeking a talented and motivated Data Scientist to join our team and play a key role in developing innovative AI solutions using the AWS technology stack. You will be responsible for developing, assessing, and fine-tuning various AI and machine learning models and oversee training, testing and deployment of these models. You will work closely with cross-functional teams, including, data engineers, AI engineers, software engineers, DevOps engineers and product managers, to bring AI-powered solutions to life and drive clinical trial acceleration and insights.</p>
Responsibilities:
<p>
ML Model Development and Deployment:
</p><ul><li>Leverage state-of-the-art deep learning techniques to build scalable and high-performance solutions that drive innovation and efficiency.</li><li>
Utilize advanced architectures such as Long Short-Term Memory (LSTM) networks, Large Language Models (LLMs) and transformer-based models (e.g., BERT, GPT, T5) for tasks like text generation, sequence modeling, entity recognition and context-aware recommendations.</li><li>
Evaluate problem requirements and data features to select and implement the most suitable AI methodologies, including self-learning, reinforcement learning or other advanced techniques.</li><li>
Ensure chosen approach aligns with business objectives while balancing model accuracy, interpretability and computational efficiency.</li><li>
Train, fine-tune and evaluate AI/ML models using AWS services such as Amazon SageMaker, Amazon Bedrock and ML Compute to ensure scalability, robustness and cost-effectiveness in cloud-based environments.</li><li>
Collaborate with engineering teams to integrate and operationalize AI models into production systems, enabling real-time predictions and data-driven decision-making while ensuring reliability, scalability and low-latency performance.</li></ul><p>
Data Expertise and Infrastructure:
</p><ul><li>Analyze, process and extract actionable insights from complex datasets stored across AWS services such as Amazon S3, Redshift, RDS and DynamoDB.
</li><li>Utilize SQL, Python and other relevant programming languages to perform data wrangling, transformation and feature engineering to support AI model development.</li><li>
Explore and visualize large-scale datasets to identify patterns, trends, correlations and anomalies that can enhance AI model training and decision-making.
</li><li>Leverage statistical analysis, data mining techniques and domain knowledge to improve data-driven insights.</li><li>
Collaborate with data engineers and AI engineers to design and optimize scalable data pipelines and infrastructure.
</li><li>Ensure seamless data ingestion, processing and integration for AI models, enhancing efficiency, automation and real-time capabilities.</li></ul><p>
Collaboration and Communication:
</p><ul><li>Communicate the insights and implications of your AI models to stakeholders in a clear and concise manner, bridging the gap between technical expertise and clinicians.</li></ul><p></p><p><br>
Stay up-to-date on the latest advancements in AI research and translate them into practical applications for the company.</p>
Qualifications:
<ul><li>4+ years of experience as a Data Scientist or similar role, with a strong focus on AI and machine learning.</li><li>
Proven experience in designing and implementing production-grade data-driven AI models.</li><li>
In-depth understanding of deep learning, self learning, reinforcement learning or other relevant AI techniques.</li><li>
Expertise in Python and familiarity with AI libraries such as TensorFlow, PyTorch, Scikit-Learn, etc.</li><li>
Strong understanding of probability theory, statistical analysis and machine learning methods.</li><li>
Excellent communication and collaboration skills.</li></ul><div><b>
CONNECT WITH US!</b></div><div><i>
Follow us on Twitter - @EmmesCRO</i></div><div><i>
Find us on LinkedIn - Emmes</i></div></div><div></div>

Senior Data Scientist

<div>Overview:<div></div><div><br>
The Emmes Company, LLC (&ldquo;Emmes&rdquo;) is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.</div><div></div><div><br>
Our &ldquo;Character Achieves Results&rdquo; culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.</div><div></div><div><br>
If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee &mdash; from entry level through top executive &mdash; to contribute to our clients&rsquo; success by sharing ideas openly and honestly.</div><div></div><div><b><br>
Primary Purpose</b></div><div></div><div><br>
Building and maintaining our data infrastructure on the AWS cloud platform, with a specific focus on supporting AI model training, development, and deployment. This includes designing, developing, and implementing data pipelines, ensuring the secure and efficient flow of data for our AI models.</div>
Responsibilities:
<ul><li><b>Data for AI:</b><ul><li>
Design and implement data pipelines specifically tailored for AI training and model development.</li><li>
Partner with AI data scientists and engineers to understand their data needs and ensure efficient data access.</li><li>
Implement data pre-processing and feature engineering techniques for optimal model performance.</li></ul></li><li><b>
AWS expertise:</b><ul><li>
Design,develop, and maintain data infrastructure on the AWS cloud platform, leveraging services like S3,Redshift, Glue, Lambda, and Kinesis.</li><li>
Build and maintain data lakes and warehouses optimized for AI workloads.</li><li>
Implement automated data transformations,cleansing, and validation processes to ensure data quality.</li></ul></li><li><b>
Coding proficiency:</b><ul><li>
Write code using Python,SQL, and other relevant programming languages, with a focus on libraries and frameworks commonly used in AI (e.g., TensorFlow, PyTorch).</li></ul></li><li><b>
Automation and monitoring:</b><ul><li>
Automate data pipelines using CI/CD tools and related techniques.</li><li>
Monitor and troubleshoot data pipelines for performance, reliability,and data quality issues.</li></ul></li></ul>
Qualifications:
<ul><li>5 to 8 years of experience as a Data Engineer or similar role,with a demonstrated experience in supporting data pipelines for AI applications and their data requirements.</li><li>
Proven experience with AWS services,including S3, Redshift, Glue, Lambda, and Kinesis.</li><li>
Strong experience with Python and SQL.</li><li>
Strong understanding of AI libraries and frameworks.</li><li>
Experience with data warehousing and data modeling concepts.</li><li>
Excellent problem-solving and analytical skills.</li><li>
Ability to work independently and as part of a collaborative team.</li><li>
Strong communication and collaboration skills.</li></ul><div><b>
CONNECT WITH US!</b></div><div><i>
Follow us on Twitter - @EmmesCRO</i></div><div><i>
Find us on LinkedIn - The Emmes Company, LLC</i></div></div>

Senior Data Engineer

Join The Emmes Company, LLC and explore 4   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

The Emmes Company, LLC

ABOUT_COMPANY

Senior Clinical Research Associate

Statistical Programmer

Senior Data Scientist

Senior Data Engineer