We bring people and data together to support tomorrow’s breakthroughs
Senior Clinical Data Manager
Location
United States
Posted
67 days ago
Salary
$100K - $125K / year
Seniority
Senior
Job Description
Senior Clinical Data Manager
eClinical Solutions
• Primary representative for eClinical Solutions and sponsor data management interaction • Responsible for monitoring and ensuring adherence to study timelines and deliverables • Accountable for the overall quality of data management activities and deliverables at the study or program level • Ensure efficiency and consistency for data management tasks across programs • Communicate with global study teams • Participate in client study kickoff and closeout/lessons learned meetings • Create materials for and present at Investigator Meetings • Develop content and deliver Sponsor CRA and/or site training • Delegate tasks, support and provide guidance to study data management team • Oversee and/or develop data management documents including DMPs, eCRF Completion Guidelines, CRFs, and Help Text • Oversee and/or Develop Internal System Testing (IST) plan for database/user roles/edit check specifications • Participate in Internal System Testing (IST) on the database/user roles/edit check specifications • Assist with preparation for implementation of a centralized data management platform for strategic data cleaning and reporting • Utilization of centralized data management platform including graphical patient profiles and operational analytics • Compile the sponsor UAT package • Oversee and/or perform data review as documented in the Data Management Plan and Data Validation Specifications • Oversee and/or perform manual review/QC checks as listed in the Data Validation Specifications exception listings and reporting tools • Oversee and/or perform data review for overall consistency and accuracy • Oversee and/or perform vendor data reconciliation (e.g., IVRS, laboratory data) with the clinical database • Oversee and/or perform query processing/resolution • Provide ongoing data management reports and metrics • Oversee and/or develop specifications and collaborate with programming for programming and QC of manual listings, external data reconciliation, metrics and custom reports as needed throughout the study • Define and develop specifications for database, programming and/or edit check changes as needed throughout the study • Track data management issues and ensure follow up to resolution • Identify data issues and/or data trends, communicate to the Clinical Data Management team and Sponsor, assist with development and implementation of action plan • Maintain data management study documentation • Perform steps pertaining to database freeze/lock and coordinate all related activities • Ongoing evaluation of process and participate in process improvement • Assist in the creation and review of SOPs, WIs, and training materials • Mentor junior level staff and peers on all associated tasks within a study • Participate in proposal defenses • Perform other duties as requested by management
Job Requirements
- Bachelor’s degree in Pharmaceutical/Biotechnology or higher in health-related field preferred
- 8+ years in Clinical Data Management experience preferred
- Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology
- Strong project management experience and project team leadership skills including work planning and work delegation
- Experience with EDC and performing data management activities
- Excellent verbal and written communication skills
- Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
- Experience with EDC and Clinical Data Management Systems
Benefits
- Health insurance
- 401(k) matching
- Paid time off
- Flexible work arrangements
- Professional development opportunities
Related Guides
Related Categories
Related Job Pages
More Data Scientist Jobs
• Develop a deep understanding of customer journey phases and key business metrics • Perform analytical deep-dives to analyze problems and opportunities, identify the hypothesis and design & execute experiments • Inform future experimentation design and roadmaps by performing exploratory analysis to understand user engagement behavior and derive insights • Create personalized segmentation strategies leveraging propensity models to enable targeting of offers and experiences based on user attributes • Identify key trends and build automated reporting & executive-facing dashboards to track the progress of acquisition, monetization, and engagement trends • Extract actionable insights through analyzing large, complex, multi-dimensional customer behavior data sets • Monitor and analyze a high volume of experiments designed to optimize the product for user experience and revenue & promote best practices for multivariate experiments • Translate complex concepts into implications for the business via excellent communication skills, both verbal and written • Understand what matters most and prioritize ruthlessly • Work with cross-functional teams (including Data Science, Marketing, Product, Engineering, Design, User Research, and senior executives) to rapidly execute and iterate
• Develop a deep understanding of customer journey phases and key business metrics • Perform analytical deep-dives to analyze problems and opportunities, identify the hypothesis and design & execute experiments • Inform future experimentation design and roadmaps by performing exploratory analysis to understand user engagement behavior and derive insights • Create personalized segmentation strategies leveraging propensity models to enable targeting of offers and experiences based on user attributes • Identify key trends and build automated reporting & executive-facing dashboards to track the progress of acquisition, monetization, and engagement trends • Extract actionable insights through analyzing large, complex, multi-dimensional customer behavior data sets • Monitor and analyze a high volume of experiments designed to optimize the product for user experience and revenue & promote best practices for multivariate experiments • Translate complex concepts into implications for the business via excellent communication skills, both verbal and written • Understand what matters most and prioritize ruthlessly • Work with cross-functional teams (including Data Science, Marketing, Product, Engineering, Design, User Research, and senior executives) to rapidly execute and iterate
• Apply statistical and econometric modeling, time series analysis, optimization methods, and generative AI to develop improved approaches to demand modeling, elasticity estimation, price recommendation, competition analytics, and related challenges. • Develop reusable tools, frameworks, and components to support and accelerate delivery of value from data science. • Deploy scalable and maintainable solutions to cloud environments, leveraging version control practices and robust code quality and documentation standards. • Work independently and as part of the Data Science Research team, contributing to research prioritisation and technical direction in collaboration with the Director and Product leadership. • Demonstrate technical excellence by delivering high-quality, innovative solutions and championing best practices to ensure research outputs are reproducible, scalable, and maintainable. • Contribute to evaluation and adoption of appropriate tools, programming languages, and technologies. • Mentor junior team members, sharing knowledge and supporting their professional development. • Identify and contribute to patent opportunities and the company's intellectual property portfolio. • Collaborate across Development, Product, Analytics, and Commercial teams to ensure solutions address business challenges and stakeholder objectives. • Partner with operational teams to ensure data pipelines and infrastructure are robust, secure, and optimized for research and production workloads. • Communicate technical concepts and outcomes effectively to both technical and non-technical audiences. • Stay current with developments in data science, machine learning, and AI, applying state-of-the-art techniques to project work. • Develop comprehensive knowledge of the retail fuel industry to understand domain challenges and help guide product innovation. • Share knowledge and promote best practices across the team and company.
Actuarial Data Scientist, Pricing Actuary
WakamWakam is a B2B2C insurance company that creates insurance via its Play&Plug® platform for its distribution partners
• Design, build, and maintain pricing and risk models for a wide range of P&C insurance products • Apply machine learning and AI algorithms to enhance pricing accuracy and risk segmentation • Lead forecasting initiatives and align insights with broader strategic and financial planning • Evaluate Wakam’s aggregate risk exposure to identify potential risk accumulation and ensure alignment with internal limits and reinsurance treaties • Track and analyze exposure levels across portfolios, focusing on sum insured, policy limits, and risk accumulation across geographical areas, product lines, and coverages • Automate and optimise the model development lifecycle • Ensure regulatory compliance and contribute to model governance best practices • Mentor junior team members and foster a high-performance analytics culture



