clinical data manager

TYG Consultant's

<p><b>Clinical Data Manager</b></p><p><b>100 percent onsite-Location: Maple Grove, MN</b></p><p><b>Hours: 8:00am-4:00 PM</b></p><p><b>Duration: This is a 6-month contract with potential to extend highly likely</b></p><p><b>Main purpose of role</b></p><p><b>Summarize the main purpose of the role.</b></p><p>The Clinical Data Manager is responsible for managing the development, documentation, and execution of risk-based quality management systems, as described in the risk assessment, data management plan, and site and central monitoring plans.</p><p>As the customer-face of Data Review and its primary liaison with the therapy group, the Clinical Data Manager's therapy-specific knowledge ensures alignment to customer definitions of criticality, and informs review and analysis of study data.</p><p><b>Main responsibilities</b></p><ul><li>Identification of study specific risks to study conduct and human subject safety; analysis of risks; development and implementation of mitigation strategies.</li><li>Review of study data to detect anticipated and unanticipated issues related to trial data completeness and quality.</li><li>Facilitate multi-stakeholder discussions to review findings, evaluate impact and develop action plans for correction and continued monitoring.</li><li>Conduct Central Monitoring activities, as described in Central Monitoring Plan.</li><li>Direct all data cleaning activity related to assigned studies.</li></ul><p><b>Qualifications</b></p><ul><li>Bachelors Degree (&plusmn; 16 years) Biology, Health Sciences, Mathematics, Computer Science, or equivalent.</li></ul><p><b>Experience/Background</b></p><ul><li>Minimum 3 years</li></ul><p><b>Experience Details</b></p><ul><li>3 years in clinical operations or healthcare related field.</li><li>Education and work experience in project management, life sciences and/or technical field.</li><li>Knowledge of data collection best practices for clinical trials.</li><li>Knowledge of global clinical operations.</li><li>Experience in consultative role, with Subject Matter Expertise, and effectively influencing a team decision to the desired outcome.</li><li>Proficient at the identification of risks in a process, evaluation of likelihood and impact, and the development of effective mitigation and monitoring strategies that are imperfect yet meet the business need.</li><li>Proficient in the translation of clinical trial requirements to the technical specifications required for effective data collection.</li><li>Skilled at making inferences and connections based on limited information, clearly describing the knowns, unknowns, and alternative explanations.</li><li>Intermediate project management skills; developing a multifaceted plan with complex dependencies and holding peers accountable to adherence to the plan while maintaining positive and collaborative relationships.</li><li>Intermediate therapy specific knowledge of anatomy, physiology, pathophysiology, therapy and device.</li></ul><p><b>Licenses and Certifications</b></p><ul><li>None required; Certified Clinical Data Manager (CCDM) or equivalent nice to have.</li></ul><p>Job Type: Contract</p><p>Pay: $42.00 - $44.00 per hour</p><p>Expected hours: 40 per week</p><p>Benefits:</p><ul><li>Health insurance</li></ul><p>Education:</p><ul><li>Bachelor's (Preferred)</li></ul><p>Experience:</p><ul><li>clinical data: 3 years (Preferred)</li><li>EDC (Electronic Data Capture): 3 years (Preferred)</li><li>central monitoring or risk-based monitoring: 3 years (Preferred)</li><li>pharma, medical device, CRO or healthcare industry: 3 years (Preferred)</li><li>overseeing clinical trial data: 3 years (Preferred)</li></ul><p>Ability to Commute:</p><ul><li>Maple Grove, MN 55311 (Preferred)</li></ul><p>Work Location: In person</p>

Clinical Data Manager (EDC/Clinical Operations/Central Monitoring) (Pharma/Healthcare)

Clariwell Global

<ul><li>Assist in entering, updating, and maintaining clinical trial data in databases.</li><li>Ensure accuracy and completeness of data received from clinical sites.</li><li>Review case report forms (CRFs) for discrepancies and inconsistencies.</li><li>Perform data validation checks and raise data queries where required.</li><li>Support in resolving data issues in coordination with site staff and clinical teams.</li><li>Assist in the design, setup, and testing of clinical databases.</li><li>Support in database lock and data transfer activities.</li><li>Maintain accurate documentation and follow standard operating procedures (SOPs).</li><li>Ensure data management processes comply with Good Clinical Practice (GCP) and regulatory guidelines.</li><li>Work closely with data managers, biostatisticians, and clinical research teams.</li><li>Participate in team meetings and ongoing training sessions.</li></ul><p>Job Types: Full-time, Permanent, Fresher</p><p>Pay: &#8377;300,556.97 - &#8377;531,557.30 per year</p><p>Benefits:</p><ul><li>Cell phone reimbursement</li><li>Health insurance</li><li>Paid sick time</li><li>Paid time off</li></ul><p>Work Location: In person</p>

Clinical data management

IQVIA

<div><p>Job Overview
<br>
Manage end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Provide leadership to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. Perform role of Data Team Lead (DTL). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.
</p><div>Essential Functions
<br>
<ul><li>Client Management:. serve as primary point of contact for customer on data management deliverables. With minimal guidance, provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise. With guidance, provide input for and perform direct negotiations with customer, e.g., timelines, financial, process, resources. Maintain strong customer relationships. Ensure open communications with customer and IQVIA management to manage and meet contractual obligations. Service Management:. Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables. Establish strong communications with Data Operations team, functional leads, project managers and all other stakeholders. With minimal guidance, support DM service delivery with comprehensive DM process and technical expertise in executing projects. Serve as the escalation point for unresolved data issues
</li><li>with guidance, work with client data managers, vendors, internal team members for resolution. Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables. With guidance, create and/or review and sign-off on all data management plan (DMP) documents. Implement proactive quality management plan. Identify any service and quality issues with agreed upon specifications per the DMP and contract/SOW and work with functional manager(s) to resolve. With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions. Continuously look for opportunities to improve efficiency of tasks and quality of deliverables. Identify compliance issues and work with functional manager(s) to ensure timely follow-up and resolution. With guidance, maintain internal tracking databases and systems. Financial Management/Business Development Support:. With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW). Manage SOW/budget. - Review financial reports on a monthly basis and participate in project reviews as requested. - Identify out of scope tasks and track change orders to completion. With guidance, may serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing. With guidance, participate in and support RFP process (review RFP documents, pricing, attend bid defense). Other:. Provide input on DM process improvements or project solutions to CDM team/CDM department. Provide input on the development and implementation of a new technology or tool. Participate in a focus team or global or local best practice team. Perform other duties as directed by functional manager(s)
</li></ul></div><div>Qualifications
<br>
<ul><li>Bachelor's Degree In health, clinical, biological or mathematical sciences, or related field with proven experience in Data Management. Req
</li><li>1-2 years of direct Data Management experience with a minimum of 6 months as a CDM project lead Pref
</li><li>Previous experience and proven competence in managing study delivery through full DM life-cycle (at least 1 medium Phase III). Demonstrated data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology). Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology. Knowledge of operating procedures and work instructions and the ability to apply them in practice. Knowledge of Good Clinical Practices and applicable regulatory guidelines. Excellent communication, interpersonal, customer service, and teamwork skills. Excellent organizational and problem-solving skills. Excellent project management skills. Ability to work with minimal supervision, using available resources, e.g., functional managers, senior DTLs. Comprehensive understanding of clinical drug development process. Ability to establish and maintain effective working relationships with coworkers, managers and customers. Previous experience and proven competence in managing study delivery through full DM life-cycle (at least 1 medium Phase III). Demonstrated data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology). Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology. Knowledge of operating procedures and work instructions and the ability to apply them in practice. Knowledge of Good Clinical Practices and applicable regulatory guidelines. Excellent communication, interpersonal, customer service, and teamwork skills. Excellent organizational and problem-solving skills. Excellent project management skills. Ability to work with minimal supervision, using available resources, e.g., functional managers, senior DTLs. Comprehensive understanding of clinical drug development process. Ability to establish and maintain effective working relationships with coworkers, managers and customers.
</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>

Data Team Lead

Parexel

<div><p><b>Job Summary:</b></p><p>
The Digital Medicine and Translational Imaging Study Manager will play a critical role in ensuring the quality of digital medicine data collected across multiple portfolio studies. This position supports the Digital Medicine and Translational Imaging group's mission to develop and implement novel technologies, with a specific focus on digital health technologies that objectively, remotely, and continuously assess patients over time using novel digital endpoints.</p><p></p><h2 class="jobSectionHeader"><b>
Key Responsibilities:</b></h2><h3 class="jobSectionHeader"><b>
Data Quality Monitoring</b></h3><ul><li>
Review and monitor multiple dashboards to ensure data is being collected as expected</li><li>
Verify participant compliance with device wear periods as specified in protocols</li><li>
Monitor data transmission and device performance (battery/memory capacity)</li><li>
Identify and follow up on necessary actions or issues</li></ul><p></p><h3 class="jobSectionHeader"><b>
Operational Support</b></h3><ul><li>
Review participant and site guides for accuracy and completeness</li><li>
Attend meetings with vendors and study staff to ensure proper site start-up and conduct</li><li>
Address troubleshooting or site-based issues related to digital medicine components</li><li>
Conduct participant follow-ups as needed</li></ul><p></p><h3 class="jobSectionHeader"><b>
Process Improvement</b></h3><ul><li>
Identify opportunities and trends to enhance standardization and efficiency of operational activities</li><li>
Collate lessons learned, frequently asked questions, and study-specific exceptions</li><li>
Contribute to the continuous improvement of digital medicine assessment processes</li></ul><p></p><h2 class="jobSectionHeader"><b>
Qualifications:</b></h2><h3 class="jobSectionHeader"><b>
Knowledge and Experience</b></h3><ul><li>
Experience with trial management of Medical Device and/or Wearable Device studies is required</li><li>
Exceptional knowledge of study management processes and deliverables</li><li>
Good knowledge in understanding the responsibilities beyond their function to ensure goals are met for the study</li><li>
Maintains expertise within the assigned therapeutic area and study to set the appropriate strategy, identify risks and to drive operational deliverables</li><li>
Working knowledge of Good Clinical Practices (GCPs), monitoring, clinical and regulatory operations</li><li>
Experience in clinical research or digital health technology implementation</li><li>
Strong attention to detail and data monitoring skills</li><li>
Excellent communication and stakeholder management abilities</li><li>
Problem-solving mindset with ability to identify trends and improvement opportunities</li></ul><h3 class="jobSectionHeader"><b>
Education</b></h3><ul><li>
Bachelor's of Science or Bachelor's of Arts degree with a minimum 7 years of relevant operational clinical trial experience required</li><li>
Master's of Science or Master's of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required</li><li>
A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology</li></ul><p></p><p>
#LI-LG4</p><br>
#LI-REMOTE</div>

Clinical Study Manager, Digital Medicine & Translational Imaging - FSP

OhioHealth

<p><b>We are more than a health system. We are a belief system.</b> We believe wellness and sickness are both part of a lifelong partnership, and that everyone could use an expert guide. We work hard, care deeply and reach further to help people uncover their own power to be healthy. We inspire hope. We learn, grow, and achieve more - in our careers and in our communities.</p><p></p><p><b>Job Description Summary:</b></p><p></p>The Senior Consultant, Research Data and Technology, will develop and lead specialized technical data and technology activities for systems being used by OhioHealth Research Institute (OHRI) and OhioHealth. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train or lead project team members and colleagues for the effective use of data and technology platforms and applications such as Research Electronic Data Capture tool (REDCap), research use in the Electronic Medical Record (EMR), the enterprise Clinical Trial Management System (CTMS) and/or other databases/applications and also serves as a liaison for Information Technology (IT) and/or Information Security (IS) requests. Under limited supervision, performs responsible and professional work involved in planning, managing, and directing operations for the systems/applications utilized by OHRI and the OH system.<br><br>In addition, this position contributes to the development of new processes, procedures tools, and training to enhance program activities and conducts quality assurance / quality control checks of the work of others. This position serves as a formal and informal leader of multidisciplinary teams establishing and maintaining communications with Investigator, project teams, sponsor, and others.<p></p><p><b>Responsibilities And Duties:</b></p><p></p>Serving as the Application / Platform Administrator for the systems (see below) - 40% <br>Reporting, Compliance & Data Integrity Needs - 30% <br>Create and maintain accurate simple and complex reports, spreadsheets, graphs and presentations, to analyze and report various financial, quality and service information as requested. <br>Audits & systems data clean-up. <br>Troubleshoot and resolve systems data issues <br>Training - 10%: Determine, develop materials and implement training for foundation staff for annual Team retreat, new associates and ongoing training needs. <br>Other duties as assigned - 20% <br><br>Application / Platform Administrator <br>Lead OhioHealth and OHRI associates as well as external collaborators to facilitate effective and compliant use of applications such as REDCap, EPIC, CTMS and/or other databases for research, QI, and/or administrative projects. <br>Oversee and lead the development, implementation, maintenance and documentation of software systems or applications, vendor-supplied programs, programs with users and vendors. <br>Collaborate with developers and end-users to ensure that application functionality meets client needs. Test solutions, problem-solve issues and coordinate enhancements. Gather business requirements; creating functional specifications; and identifying, documenting and resolving design issues. <br>Oversee team to complete system validation of new releases. <br>Provide oversight of user education on capabilities, limitations, best practices, and compliant procedures for using applications. <br>Provide oversight to maintain application access, use, and training instructions on the OHRI web site and update as appropriate. Supports and analyzes metrics integration and execution for optimal results. Plan and communicate readiness plan. <br>Serve as an escalation point for the most challenging support issues. Contact vendor or external individuals to resolve issues. <br>Oversee the building of studies, databases, survey instruments, data collection tools, and other resources for conducting research, QI, and administrative projects. <br>Employ best practices for data integrity, confidentiality, and HIPAA compliance. <br>Regularly participate and lead external administrator user group activities and meetings. <br>Coordinate with OhioHealth Information Services on server upgrades and issues to ensure data integrity and minimize downtime; and manage database maintenance as directed. <br>Provide technical input on feasibility for projects involving information systems. <br>Recommend initiatives and process improvements to OHRI leadership to meet the needs of OHRI and use resources wisely to achieve maximum results. <br><br>Compliance <br>Manage and oversee security approach and standards for infrastructure and applications. Identify security risks and mitigation approaches, using internal and external sources as appropriate. Manage access to systems including activation and deactivation. <br>Manages testing and quality assurance process. Participate in audit preparedness activities for assigned studies/projects. <br>Responsible for managing documentation and reporting for applications and other technology-based projects to ensure compliance with internal SOPs, GCP guidelines, sponsor guidelines and current applicable regulatory regulations. <br>Lead risk assessments of technology-based research activities. Communicate concerns to OHRI leadership in a timely manner. <br>Comply with hospital, departmental policies, procedures and processes. <p></p><p><b>Minimum Qualifications:</b></p><p></p>Bachelor's Degree: Computer and Information Science<p></p><p><b>Additional Job Description:</b></p><ul><li><p>Degree in computer science or related field, or related or equivalent combination of education, training and work experience in research. Strong verbal and written communication skills.</p></li><li><p>Ability and desire to provide exceptional customer service.</p></li><li><p>Demonstrated problem-solving abilities.</p></li><li><p>Strong computer skills, familiarity with database and information exchange technology.</p></li><li><p>Demonstrated experience working independently using initiative and good judgement with teams.</p></li><li><p>Ability to work effectively as part of a team.</p></li><li><p>Ability to learn complex policies and processes and to implement them independently in daily activities.</p></li><li><p>Applies critical thinking and creative problem-solving skills across a wide variety of software/application systems.</p></li><li><p>Minimum of 3 years of human subjects research experience required.</p></li><li><p>Proven track record of having successfully developed and/or managed at least one database.</p></li><li><p>Thorough knowledge of study design criteria, randomization processes, clinical and biomedical terms used in research studies and scientific and medical concepts and terminology.</p></li><li><p>Thorough knowledge of clinical trial management operations.</p></li><li><p>Thorough knowledge of Federal and institutional confidentiality policies applicable to electronic databases containing protected health information and data collected specifically for research.</p></li><li><p>Demonstrates effective communication (written and verbal), the ability to effectively and accurately exchange, transmit, receive, and interpret ideas, information and needs with colleagues and research team members through appropriate communication methods.</p></li></ul><p></p><p><b><u>SPECIALIZED KNOWLEDGE</u></b></p><ul><li><p>Advanced knowledge of principles of database and applications management.</p></li><li><p>Working knowledge of quality improvement processes.</p></li><li><p>Well-developed organizational skills with attention to details. Documented people skills and professional communication ability.</p></li><li><p>Goal-oriented person who takes initiative, is self-motivated and a creative problem solver.</p></li><li><p>Proficiency in Excel and electronic data capture systems is required. </p></li></ul><p></p><p><b><u>DESIRED ATTRIBUTES</u></b></p><ul><li><p>Master's degree in data management or related field.</p></li><li><p><b>Kind and Length of Experience</b>- 4+ years of clinical research involvement.</p></li></ul><p><br /> </p><p></p><p></p><p><b>Work Shift:</b></p>Day<p></p><p><b>Scheduled Weekly Hours :</b></p>40<p></p><p><b>Department</b></p>Research Business Services<p></p><p></p><p>Join us!<br>  if your passion is to work in a caring environment<br>  if you believe that learning is a life-long process<br>  if you strive for excellence and want to be among the best in the healthcare industry</p><p></p><p>Equal Employment Opportunity</p><p></p><p>OhioHealth is an equal opportunity employer and fully supports and maintains compliance with all state, federal, and local regulations. OhioHealth does not discriminate against associates or applicants because of race, color, genetic information, religion, sex, sexual orientation, gender identity or expression, age, ancestry, national origin, veteran status, military status, pregnancy, disability, marital status, familial status, or other characteristics protected by law. Equal employment is extended to all person in all aspects of the associate-employer relationship including recruitment, hiring, training, promotion, transfer, compensation, discipline, reduction in staff, termination, assignment of benefits, and any other term or condition of employment </p><img src="https://www.jobg8.com/Tracking.aspx?wvtE3Gkv73UaGLokyAyWwHGs7f00SQTbz" width="0" height="0" />

Sr. Research Data Technology Consultant - REDCap, CMTS and EPIC

Celerion

<div><div>Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.</div><div></div><div><br>
Are you looking for an opportunity to support a business creating life-saving treatments? If so, we can't wait to meet you!</div><div>
</div><div>
We are looking for a performance-oriented, innovative and self-motivated team player to join our Clinical Data Sciences team as a full-time <b>Electronic Data Capture (EDC) Database Developer / Clinical Programmer</b>. You will be responsible for administration of EDC Database including evaluation, analysis, design and/ or recommendations to achieve goals and excellent results in a fast-paced, ever-changing environment.</div><div>
</div><div>
This is a <b>full time, remote</b> opportunity, but may travel for training and key meetings.</div><div>
</div><div>
As an <b>EDC Database Developer,</b> you will build and administer EDC trials for client contracted projects including protocol/requirements evaluation, electronic case report form (eCRF) design and build with corresponding edits. This role will have technical interaction with vendors that are supporting the applications and troubleshoot/ escalate problems on systems to appropriate partners. This role will provide expert guidance to the design, development, validation, implementation and maintenance of study set-up. Additionally, this role will manage the deployment of EDC trials and set up interface connections between EDC and other systems.</div><br>
<div></div>
<h3 class="jobSectionHeader"><b>
In this role you will:</b></h3><ul><li>
Serve as a subject matter expert in Veeva Clinical Data Management Suite (CDMS), including Veeva Electronic Data Capture (EDC) and Veeva Clinical Database (CDB)</li><li>
Perform all activities related to eCRF design and EDC build programming for assigned projects</li><li>
Perform EDC edit check programming for assigned projects based on edit check specifications for both simple and complex edit checks</li><li>
Create test data to verify both screen design and edit check programming prior to deploying to User Acceptance Testing (UAT)</li><li>
Set up test environments and coordinate project team members for execution of test scripts</li><li>
Program and configure listings and reports using clinical reporting tools such as Veeva Clinical Database (CDB)</li><li>
Ensure secure and high-integrity database imports from vendor transfers using Celerion data transfer standards</li><li>
Assist with the validation of upgrades to hardware/ software including validation documentation development, review and execution.</li><li>
Maintain global clinical trial database standards (CDISC)</li></ul><h3 class="jobSectionHeader"><b>
Requirements:</b></h3><ul><li>
Bachelor&rsquo;s degree in a related field preferred</li><li>
3 years of clinical data management experience</li><li>
Ability to program using SQL required</li><li>
Experience with EDC systems (i.e. Veeva CDMS, Medidata RAVE, etc.)</li><li>
Experience with Veeva EDC and Veeva CDB preferred
</li><li>Proficient computer skills with understanding of clinical systems and data administration</li><li>
Must be organized, an effective written and oral communicator</li><li>
Must have the ability to multi-task, within a fast-paced environment, and build strong relationships</li></ul><div><b>
Celerion Values: Integrity Trust Teamwork Respect</b></div><div></div><div><br>
Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.</div>
<p>
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.</p></div>

EDC Developer / Programmer

<div><div>Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.</div><div></div><div><br>
As an <b>EDC Test Analyst</b>, you will serve as the critical link between database design and successful execution. You will validate clinical databases and systems that support clinical research, ensuring every study launches according to specifications.</div><div></div><div><br>
Working in collaboration with Clinical Data Managers (CDM) and EDC developers, you will manually test clinical databases against study specifications, identify issues before they impact trials, and maintain project timelines from setup through reporting.</div><div></div><div><br>
This is a remote role, working from home, anywhere in the United States.</div>
<h3 class="jobSectionHeader"><b>What You'll Do</b></h3><ul><li>
Perform comprehensive User Acceptance Testing (UAT) on clinical databases and related systems</li><li>
Create and execute detailed test scripts based on database specifications
</li><li>Coordinate with CDMs participating in UAT &ndash; providing them with test schedules, test data, direction, and detailed test scripts in accordance with study timelines</li><li>
Validate database libraries and system configuration changes per GxP requirements</li><li>
Maintain complete validation documentation in compliance with departmental SOPs</li><li>
Collaborate with multidisciplinary study teams to establish and meet timelines</li><li>
Proactively identify risks and escalate issues to management and study team members</li><li>
Communicate progress updates and coordinate testing schedules with stakeholders</li><li>
Deliver all study deliverables on time per agreed timelines</li><li>
Analyze system needs and evaluate workflow solutions</li><li>
Participate in onboarding and validation of new systems and processes</li><li>
Assist with the validation of upgrades to hardware/ software including validation documentation development, review and execution.</li></ul><h3 class="jobSectionHeader"><b>
What You Bring</b></h3><ul><li>
Bachelor's degree in IT or related field, or equivalent internal or external experience in lieu of a degree</li><li>
3-5 years industry experience</li><li>
Software validation or manual testing background</li><li>
Exceptional attention to detail and organizational skills</li><li>
Ability to juggle multiple projects simultaneously</li><li>
Strong written and verbal communication skills</li><li>
Proficiency in MS Office applications</li><li>
Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part 11 is preferred</li></ul><div><b>
Why This Role Matters:</b> Every test conducted, every issue identified, and every validation completed directly impacts the quality and reliability of clinical trial data&mdash;data that supports the development of new treatments for patients.</div><div></div><div><b><br>
Celerion Values: Integrity Trust Teamwork Respect</b></div><div></div><div><br>
Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.</div>
<p>
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.</p></div>

EDC Test Analyst

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