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, with a strong focus on ensuring SDTM compliance, traceability, and readiness for regulatory submission. 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.Possesses strong expertise in CDISC standards, particularly SDTM, including the ability to design, implement, review, and govern SDTM mapping specifications, datasets, and transformations to ensure regulatory-compliant data structures. 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.

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)

Compensation

This position offers a base salary typically between $140,000 and $222,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here .