- Accountable/Responsible to interpret requirements to translate and document them into technical
- specifications in clinical trials. Provision clinical trial data to business consumers. Facilitate
- requirements gathering from consumers and develop global solutions to meet immediate and
- long-term needs of the business. Monitor and maintain ongoing operations of clinical data
- environments and respond to issues.
- Leads and oversees all clinical data management tasks performed by an external partner.
- Oversees CRO capacities/budget for outsourced tasks.
- Develop/test different ways to constantly improve data reliability, integrity and quality. Ensures
- real-time inspection readiness of all data collection, data review deliverables for clinical trials and
- participates in regulatory agency and Client internal audits as necessary.
- Collaborate with members of the development team at Client on the project goals. Contributes to
- cross-functional and team-based thinking.
- Keep abreast of data science and in particular new data collection/curation/standardization/digital
- tech solutions and innovative processes/tools within and outside Client. Turn derived insights into
- new clinical data management approaches relevant for clinical development, registration, and
- marketing of drugs.
- Conduct and support data collection/curation/standards process and tool trainings for data
- Participate in or lead cross-functional Client internal process development teams and drive/plan
- relevant clinical data management (data collection/curation/standardization) aspects.
- Bachelor's degree from an accredited institution, in Life Sciences, Computer Science,
- Software/Computer Engineering, or similar preferred, with more than or equal to nine (>/= 9))
- years of professional experience; Or
- Master's degree (e.g. MBA, MSc) from an accredited institution, in Life Sciences, Computer
- Science, Software/Computer Engineering, or similar preferred, with greater than or equal to five
- (5) years of professional experience.
- Initial experience within the pharmaceutical industry or CROs.
- Broad knowledge and advanced experience in understanding of clinical trial development process
- In-depth knowledge and experience with the use of Data Collection Tools (EDC systems), Data
- Review Tools, Data Standardization methods and/or basic SAS/SQL programming skill required.
- Thorough knowledge/experience in design of clinical trials, basic medical terminology and on
- processing clinical trial information.
- Demonstrated ability to build/test, curate, oversee and interpret data in complex clinical trials with
- established experience.
- Intellectual curiosity to find new and unusual ways solving data collection / curation /
- standardization / process definition, testing and training issues.
- Excellent organizational skills, problem solving abilities, negotiation skills and time management
- skills required.
- Strong communication skills: Confident and persuasive communicator to ensure that the
- message is clear and well understood.
- Ability to work collaboratively on multi-disciplinary project teams and proactively manage
- relationships with external vendors required.
- Mindful of local, global, internal and external cultures to ensure that messages are received
- positively and effectively.
- Ability to lead and facilitate meetings required.
- Ability to develop and deliver (technical) training required.
- Language skills: English: fluent (Read/Write/Speak).
Let us know
Help us maintain the quality of jobs posted on RemoteTechJobs and let us know if:
As a member of the Connected Health software development team, the Senior Data Analyst is responsible for developing curated data models and reporting solutions for the mymobility/ZBEdge platform. This includes responsibility for analyzing, designing.
Technical Support EngineerDo you have a passion for solving complex, technical issues for customers? Are you customer and result-oriented and a good communicator? Do you have extensive knowledge of the hosting and data center landscape? Are you persuasive,.
Senior Project ManagerWe are a leading solutions provider of Microsoft ERP solutions for the Enterprise Construction market. SIS has immediate openings for Dynamics 365 FO Senior Project Managers. We currently have a significant pipeline of new business..
Job Description Summary:The Senior IT Project Manager will provide project management oversight of larger or more complex technology projects. This position will define, implement, and manage scope, schedule, and resources so that all project milestones.
Piper Companies is looking for a Technical Business Analyst for a leading mortgage insurance company for a 100% remote position.Responsibilities of the Technical BA Build out some identity management modules with data analytics group Collaborates with.
Under the direction of the Director of Business Intelligence, the Encounter Operations Analyst position is responsible for ensuring that Boston Medical Center Health System's Encounter Data is prepared and submitted in accordance with State and CMS contractual.