Senior Clinical Data Manager
2 weeks ago
Reports to: Director, Data Management
Position Summary
The Senior Clinical Data Manager at Fractyl Health, Inc. will be responsible for all aspects of the clinical data management activities associated with clinical database design and project oversight, resulting in quality and accuracy of the database for our clinical trial(s).
Primary Responsibilities
* Responsible for coordinating, facilitating, and participating in all data management activities from initiation of protocol, study startup through database lock with minimal oversight.
* Provide Data Management oversight for outsourced projects.
* Provide vendor management.
* Support CRF design, review, and validation of clinical database.
* Author and maintain all project start-up documents; including, but not limited to: eCRFs, eCRF Completion Guidelines, Data Management Plan, Edit Check Specifications
* Perform user acceptance testing for assigned projects.
* Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target with project timelines.
* Prepare data transfer agreements & coordinate the receipt of data transfers.
* Author all database lock documentation for assigned projects.
* Prepare all data cleaning and data status documentation; including, but not limited to: metric reports, custom reports, data review listings, reconciliation reports, clean patient tracker, etc.
* Performed ad-hoc reporting.
* Adverse event and concomitant medication coding using MedDRA and WHO-Drug.
* Responsible for SAE reconciliation.
* Provide data management timelines and cost associated in the project scope of work.
* Contribute towards process improvement, data standards and efficiency gaining initiatives within data management working with data management leadership as needed.
* Ability to support a number of moderate to complex trials with minimal supervision.
* Build successful relationships and seamless interfaces at the project team level and provide timely and effective communication to the study team, trial manager, and Biostatistics.
* Interface closely with Biostatistics and Project Management on the project level.
* Provide mentorship to junior level Data Mangers.
* Perform all activities in compliance with applicable regulations, Fractyl's policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training.
* Bring a "can do" spirit to work and deliver on other responsibilities as assigned.
Education or Certification Requirements
* Bachelor's degree in a related health profession or a field related to research compliance
* 5+ years of data management experience in a CRO or sponsor company environment
Professional Work Experience
* Knowledge of CDISC/CDASH standards
* Experience with EDC systems.
* Knowledge of medical terminology and use of coding dictionaries.
* Knowledge of ICH, FDA, and GCP regulations and guidelines related to data management.
* Applicable experience in biotech, pharmaceutical and/or medical device industries preferred.
* Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).
Qualifications and Skills
* Strong scientific background and understanding of clinical trials including pharmaceutical, device, operations, and regulatory compliance.
* Proven ability to take independent action to initiate process improvement, when needed.
Other Essentials and Key Success Factors
* Successful track record of working in high-growth and dynamic organizations
* Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
* Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
* Evidence of "hands-on" experience and expertise
* Proven and successful track record as a team-player and collaborator in small working environments
* Highly organized and detail oriented with a passion to deliver quality results
* Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation
* Highest levels of professionalism, confidence, personal values and ethical standards
Travel
This position requires no regular travel.
The description and requirements outlined above are general; additional requirements may apply.
-
Senior Managers, Strategy Development
5 days ago
Burlington, Vermont, United States Millipore Corporation Full timeSenior Managers, Strategy Development & Analytics CDMO Worksite address: EMD Millipore Corporation, 400 Summit Drive, Burlington, MA 01803 Responsibilities:Lead and support strategic initiatives to achieve business growth goals. Conduct market and financial analyses in collaboration with senior leads for business pillars to build investment plans and develop...
-
Senior Project Manager
1 week ago
Burlington, United States Cedar Gate Technologies Full timePosition Summary Reasons you will want this position: We are a rapidly growing company with limitless career growth and advancement for top performers Our culture appreciates and rewards creative ideas, especially those that achieve better outcomes for everyone This position is viewed as essential for our continued success by clients and senior...
-
Senior Project Manager
3 days ago
Burlington, United States Cedar Gate Technologies Inc Full timeJob DescriptionJob DescriptionPosition SummaryReasons you will want this position:We are a rapidly growing company with limitless career growth and advancement for top performersOur culture appreciates and rewards creative ideas, especially those that achieve better outcomes for everyoneThis position is viewed as essential for our continued success by...
-
Senior Accountant
5 days ago
Burlington, United States City of Burlington North Carolina Full timeAre you a seasoned accountant looking for an opportunity to shine in a fast-paced environment? Do you thrive on managing complex financial data and fostering collaborative relationships? If so, we want you to join our team as a Senior Accountant! Abo Accountant, Accounting, Finance Director, Senior, Project Manager, Financial Planning
-
Data Scientist
1 month ago
Burlington, Vermont, United States CoreMap Full timeWe are building a high-resolution real-time 3D electro anatomical mapping system from the ground up. This mapping system will be used during cardiac procedures to generate novel maps of atrial fibrillation using data acquired from a specialized catheter. Working together with clinical experts, you will help to analyze data and develop efficient algorithms to...
-
Senior Product Performance Analyst
4 weeks ago
Burlington, Vermont, United States LightForce Orthodontics Inc. Full timeAbout LightForce OrthodonticsLightForce Orthodontics is a 3D printing technology company focused on the orthodontic space. Our digital platform empowers orthodontists with 3D-printed tooth-moving tools. In 2019, we launched our first product - the world's only, fully customized 3D printed bracket system and digital treatment software. We are proud to be one...
-
Senior Civil Engineer
2 weeks ago
Burlington, United States Airport Solutions Group, LLC Full timeJob DescriptionJob DescriptionASG is seeking candidates for a senior engineering position to design airports and other civil site development projects. The position involves the design of airport and/or civil site development projects. The position may also involve periodic on-site observation of construction. Qualified candidates must have a BS degree in...
-
Senior Civil Engineer
3 weeks ago
Burlington, United States Airport solutions Group Full timeJob DescriptionJob Description ASG is seeking candidates for a senior engineering position to design airports and other civil site development projects. The position involves the design of airport and/or civil site development projects. The position may also involve periodic on-site observation of construction. Qualified candidates must have a BS degree in...
-
Clinical Trial Associates
3 weeks ago
Burlington, United States Cardurion Pharmaceuticals, Inc Full timeJob DescriptionJob DescriptionDescription:Why join Cardurion Pharma?At Cardurion, we are advancing the understanding of signaling pathways that regulate heart cell function. Our programs seek to modulate these pathways to reverse the pathophysiological mechanisms that drive cardiovascular disease. We invite you to explore our website to learn more about our...
-
Data Coordinator
4 weeks ago
Burlington, United States Fishing Partnership Support Services Full timeThis position works within the Evaluation department supporting the collection and use of data to drive the organization’s mission. The position will support various stages of the data lifecycle including supporting systems and people to receive data, data collection and organization, data entry, analyses, and reporting. Data includes qualitative and...
-
Director, Clinical Quality Assurance
3 weeks ago
Burlington, United States CareerBuilder Full timeJob Description Job Description Description: Why join Cardurion Pharma? At Cardurion, we are advancing the understanding of signaling pathways that regulate heart cell function. Our programs seek to modulate these pathways to reverse the pathophysiological mechanisms that drive cardiovascular disease. We invite you to explore our website to learn more about...
-
Director, Clinical Quality Assurance
4 weeks ago
Burlington, United States Cardurion Pharmaceuticals, Inc Full timeJob DescriptionJob DescriptionDescription:Why join Cardurion Pharma?At Cardurion, we are advancing the understanding of signaling pathways that regulate heart cell function. Our programs seek to modulate these pathways to reverse the pathophysiological mechanisms that drive cardiovascular disease. We invite you to explore our website to learn more about our...
-
Data Quality Analyst
6 days ago
Burlington, United States The University of Vermont Health Network Full timeThe Data Quality Analyst (DQ Analyst) works within the Data Management Office (DMO), supporting the Director of Data Quality Management on initiatives to proactively monitor, measure, analyze, execute, track and report on data quality issues. Activities will include conducting data quality assessments, data profiling, impact analysis; establishing data...
-
Data Entry 8079
2 weeks ago
Burlington, United States MedTeam Staffing Inc. Full timeThis is a contract job opportunityPosition: Data Entry 8079Location: Burlington NCSchedule:1st Shift-Mon-Fri 8AM-5PMProjected duration: 6 monthsJob code: CVDJP00028079pay rate - $15 per hourBenefits are availableSummary:The main function of a data entry specialist is to operate data entry devices, such as a keyboard or computer, to verify and input data.A...
-
Cancer Informatics and Data Specialist
2 weeks ago
Burlington, United States University of Vermont Full timePosition Details Advertising/Posting Title Cancer Informatics and Data Specialist Diversity Statement The University is especially interested in candidates who can contribute to the diversity and excellence of the institution. Applicants are required to include in their cover letter information about how they will further this goal. Posting Summary Provide...
-
Medical Director Clinical Variation Optimization
2 weeks ago
Burlington, United States Cone Health Full timeOverview The Medical Director Clinical Variation Optimization (CVO) will work closely with executive leadership, physician leaders, and the Cone Health Supply Chain Management administrative leadership to drive system wide improvement in quality of patient care delivery, reduction in waste, and improvement in cost through deployment of physician...
-
Burlington, United States Stantec Full timeDescription Stantec Buildings is on a mission to become the world's leading integrated design practice. Our architects, engineers, interior designers, sustainability specialists, and technologists are passionate about the power of design. We take an innovative, collaborative approach to projects, sharing a common belief that sustainable design for the built...
-
Senior Active Directory Administrator
6 days ago
Burlington, United States LabCorp Full timeSenior Active Directory Administrator / Cloud Architect Labcorp is a leading global life sciences company that provides comprehensive diagnostic and drug development services to patients, physicians, and healthcare organizations. Our mission is to improve health and improve lives by delivering world-class diagnostic solutions, drug development services, and...
-
Data Analyst | Hybrid
2 weeks ago
Burlington, United States IXIS Full timeOverview IXIS is seeking an energetic and curious professional to fill the position of Data Analyst for the company. The core responsibilities for this role include exploring analytics and marketing data to answer client questions, collaborating with the Data Science team to perform quantitative analyses, and summarizing key findings and strategic...
-
Data Analyst | Hybrid
2 weeks ago
Burlington, United States IXIS, LLC Full timeJob DescriptionJob DescriptionSalary: OverviewIXIS is seeking an energetic and curious professional to fill the position of Data Analyst for the company. The core responsibilities for this role include exploring analytics and marketing data to answer client questions, collaborating with the Data Science team to perform quantitative analyses, and summarizing...