August 8, 2022
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United States, United States
August 8, 2022
Apply NowJob description
Key contact partner in cultivating the power of data by means of (i) data collection/curation, data review, data delivery, (ii) data standardization or (iii) process definition, testing and training.
Translate the science into technical specifications. Collect, ingest, structure, curate and standardize all kinds of Clinical Trial related data from internal and external sources. Ensure Data Quality and Integrity by implementing plausibility checks, anomaly detection, and fraud detection methods in data collection systems.
Supports the clinical research development process through the provision of advanced expertise in the areas of (i) data collection/curation, data review, delivery (ii) data standardization or (iii) process definition, testing and training.
This position interprets scientific/clinical requirements to translate and document them into Therapeutic Area/Project level technical specifications for new substances, indications or marketing claims.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities:
- Accountable/Responsible to interpret requirements to translate and document them into project/TA level technical specifications. Provision clinical project/ TA level 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 project/ TA level operations of clinical data environments and respond to project/TA issues.
- Leads and oversees all CDE tasks performed by an external partner. Oversees CRO capacities/budget for outsourced trial/project tasks.
- Develop/test different ways to constantly improve data reliability, integrity and quality. Ensures real-time inspection readiness of all data collection, data review/data delivery (DBL) deliverables for a trial/project and participates in regulatory agency and BI internal audits as necessary.
- Collaborate with/influence members of the development team within BDS and with neighboring colleagues at BI on the project/product 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 BI. Turn derived insights into new CDE approaches relevant for clinical development, registration, and marketing of drugs.
- Conduct and support data collection/curation/standards process & tool trainings for Clinical Data Engineers.
- Participate in or Lead cross-functional BI internal process development teams and drive/plan relevant CDE (data collection/curation/standardization) aspects. Participate in external working groups.
Requirements:
- Bachelor’s degree from an accredited institution, in Life Sciences, Computer Science, Software/Computer Engineering, or similar preferred, with many (greater than or equal to seven (>/= 7)) 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 three (3) years of professional experience.
- Initial experience within the pharmaceutical industry, CROs or academic sites.
- Leadership experience required.
- Broad knowledge and advanced experience in understanding of clinical trial development process required.
- In-depth knowledge and experience with the use of Data Collection Tools (EDC systems), Data Review Tools, and/or Data Standardization methods, requirements
- 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 trial and in projects with established BI 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, time management skills and initiative 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).
- Know, understand, and implement:
- International regulations and guidelines for good clinical and statistical practice from all ICH regions
- 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)
Eligibility Requirements:
- Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and post-offer physical (if required).
- Must be 18 years of age or older.
Who We Are:
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.
Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
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Job - Medicine / Regulatory Affairs
Primary Location - Americas-United States
Organization - US-BI Pharma/BI USA
Schedule - Full-time
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