Your tasks and responsibilities
The primary responsibilities of this role, Technical Expert, are to:
Who you are
- Establish implementation strategy for software, integrations and data review toolkits within existing end to end business processes;
- Lead technical implementation for the software tools (Rave, LSH, MDR, DMW ) and integrations to be used in data collection and processing;
- Lead software evaluation activities with software vendors and IT partners (ie, SIS, BBS) in context of operational usage with end to end interoperability;
- Lead enablement of common technology platforms for data acquisition and processing, integrations, and utilities for internal and outsourced clinical trials;
- Lead technical design, build, maintenance of software utilities for usage by study teams for data acquisition and data management in clinical trials;
- Designs and documents operational processes for adoption of new and updated software utilities, integrations and toolkits aiming for process and toolkit connectivity across platforms such as Rave, LSH, MDR, DMW;
- Lead implementation of quality and reconciliation activities for external data (i.e., Central Labs, ECG, adjudications) within studies;
- Support implementation of data provisioning for usage in studies for clinical trial reporting with appropriate data models;
- Participate in validation activities related to software utilities and integrations release. Includes testing, writing test scripts, validation plans and associated reports;
- Collaborate with functional representatives to provide software related technical and process training;
- Participate in industry initiatives to assess and further CI&A adoption of new technologies;
- Provide support to business partners for software related audits/inspections by internal and external teams;
- Understand and support monitoring of the technical performance of the software utilities, applications and apply these finding to improve operational performance of utilities and integrations;
- Coach and mentor study teams on specific technical requirements related to unique study designs and requirements;
- Other duties as assigned.
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- Master's/Bachelor's degree
- Ten (10) years In-depth experience in design and developing tools and utilities on commonly used technology platforms (ie RAVE, LSH, DMW, Patient Cloud, Oracle Clinical) for data acquisition and associated review, and reporting (i.e., JReview, SpotFire);
- Knowledge and hands on experience in programming languages such as C#, SQL, PL/SQL, JAVA, SAS;
- Knowledge and experience in clinical trial start up, conduct and close out activities and associated technical best practices;
- Hands-on experience with the tools and utilities for the management of pharmaceutical sponsor proprietary or industry clinical data standards (ie sponsor specific or CDISC);
- Understanding of industry standards on integration technology such as web services and odm.xml;
- Effective time management skills to ensure completion of assigned task within planned timelines;
- Understanding of global regulatory requirements, rules and guidance's associated with Source Data in Clinical Investigations including CFR part 11;
- Experience in comprehensive software validation activities using different methodologies (ie waterfall, agile etc), inspections, analyses, and other verification tasks performed at each stage of the software development life cycle;
- Effective written and verbal communication in English and usage of Microsoft Office.
- Experience in project management tasks and managing multiple integrations and toolkits as assigned is desired;
- Effective interaction and training of teams in the understanding and usage of standards and technology is desired.
sroennau Your application
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. Country:
United States Location:
A little about us:
Why Bayer? Because we’re a pioneer in the fields of human, animal, and plant health. Because we invent solutions that will create a sustainable future for our planet. Because a career with Bayer means you can put your passion into practice and make an impact.