clinical data manager

Exelo Technologies Inc

<ul><li>Lead CDM activities for assigned clinical studies, ensuring data quality and compliance with study timelines.</li><li>Design and/or support the design of clinical databases in alignment with study protocols and requirements, including creation of edit checks and dynamic functionalities.</li><li>Conduct User Acceptance Testing (UAT) to validate clinical database functionality and accuracy.</li><li>Author, review, and approve study-specific CDM documentation such as Data Management Plans (DMPs), Case Report Form Completion Guidelines (CCGs), Data Transfer Agreements (DTAs), and EDC specifications.</li><li>Support data cleaning and validation activities to ensure completeness and accuracy of study data.</li><li>Monitor study progress to ensure milestones are met and deliverables are achieved on schedule.</li><li>Oversee and manage CDM vendors to ensure high-quality deliverables and adherence to project timelines.</li><li>Ensure all CDM operations comply with applicable Standard Operating Procedures (SOPs) and regulatory guidelines.</li><li>Identify and communicate potential risks or challenges to the Head of CDM and Clinical Project Manager (CPM), and collaborate with the study team to develop and implement risk mitigation strategies.</li><li>Ensure timely and accurate filing of CDM documentation in the Trial Master File (TMF).</li><li>Supervise and provide guidance to junior CDM staff on assigned studies.</li><li>Perform additional CDM-related duties as required.</li></ul><p><b>Qualification Requirements:</b></p><ul><li>Bachelor&rsquo;s degree in a health-related, scientific, or equivalent field.</li><li>5&ndash;8 years of experience in Clinical Data Management role.</li><li>Strong understanding of Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) guidelines, and CDM processes.</li><li>Hands-on experience with multiple Electronic Data Capture (EDC) systems.</li><li>Familiarity with additional CDM tools and analytics platforms preferred.</li><li>Advanced proficiency in Microsoft Excel (formulas, pivot tables); basic knowledge of SAS or other programming languages is an advantage.</li><li>Proficient in Microsoft Office Suite, Microsoft Teams, and SharePoint.</li><li>Excellent written and verbal communication skills.</li><li>Strong organizational skills with keen attention to detail.</li><li>Proven ability to prioritize, manage multiple tasks, and meet deadlines effectively.</li></ul><p>Job Types: Full-time, Contract</p><p>Pay: $75,000.00 - $100,000.00 per year</p><p>Work Location: Remote</p>

Clinical Data Manager

ICON plc

<div>Manager Clinical Data Science, Trivandrum, India<div></div><div>
ICON plc is a world-leading healthcare intelligence and clinical research organization. We&rsquo;re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development</div><div></div><div>
We are currently seeking a Manager, Clinical Data Science to join our diverse and dynamic team. As a Manager, Clinical Data Science at ICON, you will play a pivotal role in overseeing the analysis and interpretation of clinical data to support drug development and improve patient outcomes. You will contribute to the advancement of innovative treatments through strategic leadership in data management and analytics, ensuring the highest standards of quality and compliance in clinical research.</div><div>
What You Will Be Doing:</div><div></div><ul><li>
Driving the analysis of clinical trial data to derive actionable insights and support decision-making processes.</li><li>
Collaborating with cross-functional teams to ensure effective data collection, management, and reporting throughout clinical trials.</li><li>
Overseeing the implementation of best practices in data science methodologies and technologies within the organization.</li><li>
Providing mentorship and guidance to junior data scientists, fostering a culture of continuous improvement.</li><li>
Establishing strong partnerships with internal and external stakeholders to enhance data integrity and optimize clinical outcomes.</li></ul><div>
Your Profile:</div><div></div><ul><li>
Advanced degree in a relevant field such as biostatistics, data science, or a related discipline.</li><li>
Extensive experience in clinical data analysis, with a solid understanding of regulatory requirements and industry standards.</li><li>
Strong leadership skills with the ability to inspire and manage teams effectively in a collaborative environment.</li><li>
Proficiency in statistical software and programming languages, with a keen ability to translate complex data into clear insights.</li><li>
Excellent communication and interpersonal skills, with a track record of influencing stakeholders and driving positive change.</li></ul><div></div><div>
What ICON can offer you:</div><div></div><div><div><div><div><div>
Our success depends on the quality of our people. That&rsquo;s why we&rsquo;ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.</div><div></div><div>
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.</div><div></div><div>
Our benefits examples include:</div><ul><li><div>
Various annual leave entitlements</div></li><li><div>
A range of health insurance offerings to suit you and your family&rsquo;s needs.</div></li><li><div>
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.</div></li><li><div>
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family&rsquo;s well-being.</div></li><li><div>
Life assurance</div></li><li><div>
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.</div></li></ul></div></div></div></div><div></div><div>
Visit our <div>careers site</div> to read more about the benefits ICON offers.</div><div></div><div>
At ICON, inclusion &amp; belonging are fundamental to our culture and values. We&rsquo;re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</div><div></div><div><div><div><div><div>
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know</div><div></div><div><div>
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless &ndash; there&rsquo;s every chance you&rsquo;re exactly what we&rsquo;re looking for here at ICON whether it is for this or other roles.</div></div></div></div></div></div></div><div></div>

Manager Clinical Data Science

IQVIA

<div><p>Job Overview<br>
Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager.</p><div>
Essential Functions<br>
<ul><li>Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e.g., coder, tester or database designer for technologies that don't require extensive programming expertise) with guidance.</li><li>May serve in the role of back-up to a DOC or DTL.</li><li>May conduct data review.</li><li>May write and resolve data clarifications.</li><li>May lead database audit team.</li><li>May develop and test databases and edit specifications.</li><li>May perform testing of programming.</li><li>May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team.&quot;</li></ul></div><div>
Qualifications<br>
<ul><li>Bachelor's Degree Clinical, biological or mathematical sciences, or related field Req</li><li>Equivalent combination of education, training and experience in lieu of degree.</li><li>Medical terminology exposure. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Medical terminology exposure. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients.</li></ul></div><p></p><p>
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com</p></div>

Clinical Data Management

Medpace

<div>Job Summary :
<div>
Our global activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Database Designer to join our Biometrics team. This position will work in a team to accomplish tasks and projects that are instrumental to the company&rsquo;s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.</div>
Responsibilities :
<ul><li>Maintain eCRF and Edit Check Specification standard templates according to CDISC standards for data collection and data submission;</li><li>
Develop and maintain eCRF specifications on a study-by-study basis (e.g., reviewing protocol and customize library eCRFs to apply for the study) from database build through database lock (including Change Requests);</li><li>
Develop and maintain Edit Check Specifications from database build through database lock (including Change Requests) to ensure that all data collected are present, logical, and per expected protocol assessment schedule and completion guidelines;</li><li>
Perform validation of both the eCRF and the edits per the specifications ensuring that all possible entry scenarios are tested and documented. Accountable for providing reliable and concise feedback to clinical data programmer;</li><li>
Liaise and educate the Data Manager and Sponsor to ensure that eCRFs are well understood, and the EDC database is set up per Sponsor expectations (e.g., attend ongoing meetings with the Sponsor during setup of study);</li><li>
Liaise with Clinical Db Programmer to ensure that eCRF and Edit Check Specifications are clearly defined and can be accomplished in the referenced system;</li><li>
Design and develop customized project-level reports that are useful to the team via the reporting tools within the EDC systems (e.g., Business Objects, JReview);</li><li>
Lead eCRF specification review meetings with internal project team to discuss eCRF specifications; and</li><li>
Lead eCRF specification review meetings with external project team to discuss eCRF specifications and speak knowledgeably about decisions made and technical design options if Sponsor does not agree with current design.</li></ul>
Qualifications :
<ul><li>Bachelor&rsquo;s degree/Advanced degree in Life Sciences or Computer Science or equivalent;</li><li>
At least one year experience building specifications and/or performing UAT for EDC databases</li><li>
Excellent verbal and written communication skills; and</li><li>
Meticulous attention to detail.</li></ul>
Medpace Overview :
<div>
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.</div>
Why Medpace? :
<div>
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.</div><div></div><div><br>
The work we&rsquo;ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.</div><div></div><p><b><br>
Medpace Perks</b></p><ul><li>
Flexible work environment</li><li>
Competitive compensation and benefits package</li><li>
Competitive PTO packages</li><li>
Structured career paths with opportunities for professional growth</li><li>
Company-sponsored employee appreciation events
</li><li>Employee health and wellness initiatives</li></ul><div><b>
Awards</b></div><ul><li>
Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024</li><li>
Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility</li></ul><div></div><div><b><br>
What to Expect Next</b></div><div>
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.</div></div>

Clinical Database Designer (Mumbai)

IQVIA India

<div>
 <p>
  <strong>
   Project Role:
  </strong>
  Clinical Data Specialist (UAT)
 </p>
 <p>
  <strong>
   Work Experience
  </strong>
  : 2-5 Years.
 </p>
 <p>
  <strong>
   Work location:
  </strong>
  Kochi/Kolkata/Bangalore
 </p>
 <p>
  <strong>
   Work Mode:
  </strong>
  Hybrid
 </p>
 <p>
  <strong>
   Must Have Skills:
  </strong>
  Clinical data management, Start up, UAT Shift Timings: 5:00 am -2:00 pm / 2:00 pm &ndash; 11:00 pm. The shift assignment is purely based on project requirements and the candidate must be open to working in either of two shifts. FYI: Transportation boundary is 35 KM. no exceptions.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Job Overview:
  </strong>
 </p>
 <p>
  Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Job Responsibility:
  </strong>
 </p>
 <p>
  &bull; Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e.g., coder, tester or database designer for technologies that don't require extensive programming expertise) with guidance.
 </p>
 <p>
  &bull; May serve in the role of back-up to a DOC or DTL.
 </p>
 <p>
  &bull; May conduct data review.
 </p>
 <p>
  &bull; May write and resolve data clarifications.
 </p>
 <p>
  &bull; May lead database audit team.
 </p>
 <p>
  &bull; May develop and test databases and edit specifications.
 </p>
 <p>
  &bull; May perform testing of programming.
 </p>
 <p>
  &bull; May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team
 </p>
 <p>
  &bull; Interprets the study protocol. Providing knowledge in validation tasks and performing database validation efforts to ensure delivery of high-quality databases.
 </p>
 <p>
  &bull; Accountable for overall quality and delivery of the validation effort.
 </p>
 <p>
  &bull; Develop and test databases and edit specifications.
 </p>
 <p>
  &bull; Meeting objectives as assigned.
 </p>
 <p>
  &bull; Develop and test databases and edit specifications, this includes:
 </p>
 <p>
  &bull; Performs UAT for Edit Checks and Database
 </p>
 <p>
  &bull; Updates the Edit check status appropriately
 </p>
 <p>
  &bull; Communicates issues for erroneous Edit Checks to the programmer within the Data Management Plan
 </p>
 <p>
  &bull; Communicates any documents updates or uncertainties to the Lead Data Manger within the Data.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Technical Skills:
  </strong>
 </p>
 <p>
  &bull; Understand and comply with core operating procedures and working instructions.
 </p>
 <p>
  &bull; Develop and maintain good communications and working relationships with CDM team.
 </p>
 <p>
  &bull; Communicate ideas for process improvement.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Educational Qualification:
  </strong>
 </p>
 <p>
  &bull; Bachelor's Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology Req
 </p>
</div>


Clinical Data Specialist (UAT)

<div><p><b>Business Introduction:<br>
</b></p><p><br>
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&amp;D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people&rsquo;s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients&rsquo; needs and have the highest probability of success. We&rsquo;re uniting science, technology, and talent to get ahead of disease together.
<br>
Find out more:
<br>
Our approach to R&amp;D<br>
<br>
<br>
<br>
<b>Position Summary:<br>
</b></p><p><br>
As a Senior Analyst in Data Acquisition, you will play a key role in ensuring high-quality data collection and management for clinical studies. You will collaborate with cross-functional teams and external partners to design, implement, and oversee data acquisition processes. This role offers an opportunity to make a meaningful impact on advancing healthcare while growing your expertise in data management and clinical research.<br>
<br>
</p><div><b>Key Responsibilities:
</b></div><p></p><div><div><div><div><div><div><div><div><div><ul><li>Performs the study set-up activities and the technical development of Electronic Data capture (eDC) solutions and associated tools for one or more clinical studies.
</li></ul><ul><li>Assist with the technical &amp; vendor oversight of multiple data types for one or more clinical studies
</li></ul><ul><li>Support the delivery of one or more Clinical studies depending upon the phase, complexity, and similarity with support of junior data acquisitions staffs as required.
</li></ul><ul><li>For studies, key responsibilities include:
</li></ul>o Provides input to study design, the clinical protocol, study planning and review of study documents as appropriate.
<br>
o Coordinates review, revision, and approval of study specification documents (including operational requirements &amp; specifications) and/or key vendor deliverables (including translations)
<br>
o Understands, mediates and solves issues related to Data acquisition Develops the study eDC application and associated documents including forms, data validation checks &amp; data extraction and ensures delivery with quality and on time
<br>
o Provides reports, status updates, feedback, and raises risks and advice to Study Data Manager about study set-up and/or vendor related activities
<br>
o Ensures quality control of deliverables.
<ul><li>Provide inputs to process improvements, new processes, training, quality assessments, audits and inspections related to the Data Acquisition.
</li><li>Responsible for performing after-action reviews (success or failure) to share learnings and propose improvements for the future.
</li><li>Extensive working knowledge of GxP, ICH requirements, internal processes and external regulations that govern drug development (where applicable).
</li></ul></div></div></div></div></div></div></div></div></div><p></p><p><b>Why GSK?
</b></p><p><b>Uniting science, technology and talent to get ahead of disease together.
</b></p><p></p><p>GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases &ndash; to impact health at scale.
</p><p></p><p>People and patients around the world count on the medicines and vaccines we make, so we&rsquo;re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
</p><p></p><p><b>Inclusion at GSK:
</b></p><p>As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.
</p><p></p><p>Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.
</p><p></p><p><b>Important notice to Employment businesses/ Agencies
</b></p><p>GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
</p><p></p><p>It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way.
</p><p></p><p><b>GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.
</b></p><p></p><p>If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in &ldquo;gsk.com&rdquo;, you should disregard the same and inform us by emailing askus@gsk.com , so that we can confirm to you if the job is genuine.</p></div><p></p>

Senior Analyst, Data Acquisition

Accenture

<p><b>Skill required:</b> Clinical Data Services - Clinical eTMF Management<br>
<b>Designation:</b> Clinical Data Svs Associate<br>
<b>Qualifications:</b>Bachelor of Pharmacy
<br>
<b>Years of Experience:</b>1 to 3 years
<br>
<b>About Accenture</b><br>
Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song&mdash; all powered by the world&rsquo;s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com
<br>
<b>What would you do?</b> You will be aligned with our Life Sciences R&amp;D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance &amp; Regulatory, helping the world&acirc;&euro;&trade;s leading biopharma companies bring their vision to life &acirc;&euro;&ldquo; enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects. Strategies, methods and tools used throughout the lifecycle of the clinical trial regulated content. Includes data review and accuracy checks of trial master file table of contents, head quarters, initial full protocol package and amended FPP checklists, end of trial checklists, essential document reconciliation, and clinical study report appendices.<br>
<b>What are we looking for?</b> &bull;Adaptable and flexible &bull;Ability to perform under pressure &bull;Problem-solving skills &bull;Detail orientation &bull;Ability to establish strong client relationship
<br>
<b>Roles and Responsibilities:</b> Document Administrators are responsible for carrying out format check of documents requiring eCTD compliance for New Drug Application/Marketing Authorization Submission. The format check ensures that the technical quality of submission documents in eCTD compliant and meets the document format standards (e.g., PDF property checks, good documentation practice and bookmark/hyperlink checks).</p>
<br>
Bachelor of Pharmacy

Clinical Data Svs Associate

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