Clinical Data Manager I

<p class=""p1"">Here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve the eyesight of people worldwide. Because we&rsquo;re a rapidly growing company with a dynamic, fast-paced culture, employees here are empowered with more diverse and enriching challenges than might not be possible at a larger company.</p>

United States


<h4>Founded in 1998, Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.</h4> <h4>Our company was the first company to bring to market Micro-Invasive Glaucoma Surgery (MIGS), the micro-invasive procedure which revolutionized the treatment and management of glaucoma. In 2012, we launched our first MIGS device&mdash;the iStent&reg;&mdash;in the United States, followed by our next-generation iStent&nbsp;inject&reg;&nbsp;device in September 2018 and iStent&nbsp;inject&reg;&nbsp;W in September 2020.</h4> <h4>In November 2019, Glaukos acquired Avedro, maker of the first and only FDA-approved cross-linking technology for progressive keratoconus. And we continue to seek to leverage our platform technologies to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies for glaucoma, corneal health, and retinal diseases.</h4>

keywords: position summary,assist,oversee,initiate,software development,procedure,analysis,support,represent,experience,knowledge,education,skills

Full time

Overview: The Clinical Data Manager is responsible for study Data Management activities from study start up to close out. Providing input into the data cleaning strategy and leading data cleaning efforts supporting Clinical Studies. This individual must possess strong project management and analytical skills and have the ability to review data using various reporting and analytics tools.
Responsibilities: <ul> <li>Support with writing, reviewing and management of key documents such as Data Management Plan, Project Plan, CRF completion guidelines, edit check specifications, data review guidelines. &nbsp;</li> <li>Monitor the User Acceptance Testing (UAT) of clinical databases including EDC. &nbsp;</li> <li>Initiate and support cross-functional Data Management meetings and discussions with Study Managers, Clinical Study Teams, Project Managers, Programming and Regulatory. &nbsp;</li> <li>Oversee delivery of EDC study deliverables. &nbsp;</li> <li>Oversee and support data cleaning efforts and perform regular data review across Glaukos studies. Perform data review to identify quality issues, data trends/outliers and generate queries as necessary. &nbsp;</li> <li>Represent Data Management in study team meetings, providing data status metrics and providing guidance on issues related to data management &nbsp;</li> <li>Perform review of study SAS and SDTM datasets. &nbsp;</li> <li>Provide input and review of clinical data from external sources and assist in data reconciliation. &nbsp;</li> <li>Work with programming to produce customized reports or data listings to facilitate data review and cleaning (e.g. safety reviews). &nbsp;</li> <li>Generate reports or data listings for study teams as needed. &nbsp;</li> <li>Assist medical coding, AE/SAE reconciliation. &nbsp;</li> <li>Assist with CDM project documentation including vendor files in an audit- ready manner. &nbsp;</li> <li>Assist in the monitoring of enrollment information as collected in the database, provide status update to the study team. &nbsp;</li> <li>Assist with the preparation of Data Management training materials used for Investigator meetings, in-house personnel and site staff. &nbsp;</li> <li>Contribute to the development of departmental processes and procedures.</li> </ul>
Requirements: <ul> <li>0-2 years of experience working in Pharmaceutical/ Medical Device/ Biotechnology/ CRO industry in Clinical Data Management is required. &nbsp;</li> <li>Preferred experience in Ophthalmology Therapeutic area.</li> <li>Knowledge of FDA/ICH guidelines and industry/technology standard practices &nbsp;</li> <li>Knowledge of Data Management Practices and other regulatory guidelines specific to data management&nbsp;</li> <li>Electronic Data Capture (EDC) systems (e.g. Inform, RAVE, iMedNet, etc.), database design and database concepts preferred. &nbsp;</li> <li>Ability to use various data review tools &nbsp;</li> <li>Project Management experience &nbsp;</li> <li>Experience writing Data Management documentation (E.g. DMP, edit check specifications etc.) &nbsp;</li> <li>Excellent verbal and written communication skills &nbsp;</li> <li>Experience working with CDISC Standards (CDASH, SDTM) &nbsp;</li> <li>Experience with SQL, SAS, Excel or other programming language a plus.</li> <li>BS or higher in biological science, nursing or other health-related discipline preferred.​&nbsp;</li> </ul> <br /> <p><strong>Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.</strong>&nbsp;</p> <p>These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.</p> <p>Those may seem like big aspirations, but here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve eyesight of people worldwide. And because we&rsquo;re a rapidly growing company with a dynamic, fast-paced culture, individual employees are empowered with more diverse and enriching challenges that might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others.</p> <p>We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off &amp; paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Moreover, Glaukos Corporation has been Certified as a Great Place to Work the last&nbsp;three years!</p> <p>Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.</p>