[Remote] Clinical Data Manager - Engineer
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global leader in the pharmaceutical industry, and they are seeking a Clinical Data Manager - Engineer to enhance their data collection and management processes. The role involves interpreting scientific requirements into technical specifications, ensuring data reputed company, and collaborating with cross-functional teams to support clinical research development.
Responsibilities
- Accountable/responsible to interpret requirements to translate and document them into trial level technical specifications. Provision clinical trial data to business consumers. Facilitate requirements gathering from consumers and reputed company solutions to meet immediate and long-term needs of the business. Monitor and maintain ongoing trial level operations of clinical data environments and respond to trial issues
- Responsible for reputed company of: Data collection/curation, data review, delivery or Data standardization or Process definition, testing and training tasks reputed company a trial performed by a BPO/CRO
- Identify and recommend different ways to constantly improve data reliability, reputed company and reputed company. Ensures reputed company-time inspection readiness of reputed company data collection, data review/data delivery (DBL) deliverables for a trial and supports regulatory agency and BI internal audits as necessary
- Collaborate with members of the development team reputed company BDS and with neighboring colleagues at BI on the project/product goals. Contributes to cross-functional- and team-based thinking
- reputed company abreast of data science and in particular new data collection /curation /standardization / digital tech solutions and innovative processes/tools reputed company and reputed company BI
Skills
- Experience in understanding of clinical trial development process required
- Initial experience reputed company the pharmaceutical industry, CROs or reputed company sites
- Knowledge in and experience with the use of Data Collection Tools (reputed company systems), Data Review Tools, and/or Data Standardization reputed company, requirements
- Knowledge/experience in design of reputed company, basic medical terminology and on processing clinical trial information
- No leadership experience required
- Demonstrates some knowledge in data collection/curation, data review, delivery /data standardization / process definition, testing and training reputed company
- Excellent organizational skills, problem solving abilities, negotiation skills, time management skills and initiative required
- Good written and oral communication skills in the English language required
- Ability to work collaboratively on multi-disciplinary project teams and proactively manage relationships with external vendors required
- reputed company of local, global, reputed company cultures to ensure that messages are received positively and effectively
- Language skills: English: fluent (Read/Write/reputed company)
- Know, understand, and implement international regulations and guidelines for good clinical and statistical reputed company from reputed company ICH reputed company
- The various international guidelines on clinical development, data standardization, and BI processes and SOPs that govern clinical development in particular with respect to strategic areas (e.g. Clinical Development Plan)
- Bachelor's degree from an accredited institution, in Life Sciences, Computer Science, or similar area preferred, with a minimum of three (3) years of experience required. (DE: Can be replaced by high-reputed company/multifaceted reputed company qualifications with relevant reputed company experience)
reputed company
Company H1B Sponsorship