Clinical Data Manager - Engineer

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Clinical Data Manager - Engineer

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 good knowledge 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 Trial 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, 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 trial level technical specifications. Provision clinical trial data to business consumers. Facilitate requirements gathering from consumers and develop 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 oversight of:

• Data collection/curation, data review, delivery or

• Data standardization or

• Process definition, testing and training tasks within a trial performed by a BPO/CRO

• Identify and recommend 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 and supports regulatory agency and BI internal audits as necessary.

• Collaborate with 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.

Requirements

• 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-quality/multifaceted professional qualifications with relevant professional experience).
• Experience in understanding of clinical trial development process required.
• Initial experience within the pharmaceutical industry, CROs or academic sites.
• Knowledge in and experience with the use of Data Collection Tools (EDC systems), Data Review Tools, and/or Data Standardization methods, requirements.
• Knowledge/experience in design of clinical trials, 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 methods.
• 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.
• Mindful of local, global, internal and external cultures to ensure that messages are received positively and effectively.
• 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)

Compensation Data

The base salary range for Clinical Data Engineer is $115,000.00 to $181,000.00. The position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements.  We continuously review market data and may adjust salary ranges as needed in the future.  Actual compensation will be based on job-related factors such as skills, experience, and qualifications, and other factors permitted by law. For an overview of our benefits please click here.

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