Senior Clinical Data Engineer (Clinical Data Manager) OR Principal Clinical Data Engineer (Principal Clinical Data Management) –Remote
***Candidate will be hired commensurate with the level and experience***
***Working on a remote basis is applicable to only those in Eastern and Central US Time Zones***
Senior Clinical Data Engineer (Clinical Data Manager)
Description:
Key contact partner in cultivating the "power of data" by means of:
- Data collection/curation, data review, data delivery
- Data standardization or
- 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, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Senior Clinical Data Engineer (Clinical Data Manager)
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
- 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.
Senior Clinical Data Engineer (Clinical Data Manager)
Requirements:
- Bachelor’s degree from an accredited institution, preferably in Life Sciences, Computer Science, or similar area, with a minimum of three (3) years of experience;(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.
- 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
- BI processes and SOPs that govern clinical development in particular with respect to strategic areas (e.g. Clinical Development Plan)
Principal Clinical Data Engineer (Principal Clinical Data Management)
Requirements:
- Bachelor’s degree from an accredited institution, preferably in Life Sciences, Computer Science, Software/Computer Engineering, or similar area, with several (greater than or equal to seven (>/= 7)) years of initial experience within the pharmaceutical industry, CROs or academic sites;Or
- Master’s degree (e.g. MBA, MSc) from an accredited institution, preferably in Life Sciences, Computer Science, Software/Computer Engineering, or similar area, with greater than or equal to three (>/= 3) years of initial experience within the pharmaceutical industry, CROs or academic sites.
- 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.
- Broad knowledge and advanced experience in understanding of clinical trial development process required.
- 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
- 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.
- This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation. Click here for more information on the vaccine mandate and COVID-19.
Compensation: This position offers a base salary typically between 114,500 and 143,100. There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. 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.
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.