The Process Integration Manager is responsible forensuring consistency in the facilitation and definition of theintegrated End-
to-End processes and models for the Clinical DataEnvironment in support of operational use by various Data Sciences& Analytics (DSA) functions.
The incumbent will ensurefacilitation of functional cooperation across DSA resulting ininteroperability and integration of objects in all systems.
The purpose is to collaborate with management and trainers toensure the full uptake of integrated processes by all colleaguesrelated to operational use of the Clinical DataEnvironment
Foster the One DSA approach and acts as arole model in terms of Bayer values and DSAcharacteristics
Leadership for providing organization / systems / processknowledge and coordination support for operational use of theClinical Data Environment(s).
Ownership of and act as Center of Excellence for thebusiness processes for the management and utilization of theClinical Data Environment related to the data repository set-
up,integration / exchange (including data exchange with CROs andvendors), transformation and providing to businessconsumers
Accountable for addressing areas where standards are noteffectively implemented, while embedding these concepts in relevantStandard Operation Procedures (SOPs), Operation Instructions (OIs),and Best Practice Documents
Provide support to the DS&A Community with respect tounderstanding the integrated business processes and end-to-end dataflow process to successfully work in the Clinical DataEnvironment
Responsible for managing the external consultancyresources that support the initial implementation of the SpectrumClinical Data Environment.
Scope of support by consultancyresources include business process and system integrationprocesses, environment programming support and Accenture LifeSciences Cloud Coalition (ALSC) operationalstabilization
Leads ALSC integration into the strategic initiatives aroundData as an Asset and the data retrieval from other BayerSystems
Represents Bayer in Accenture Life Sciences Cloud Coalitionmeetings on development of The Oracle Data Management Workbenchapplication and wider industry initiatives around data standardsusage in clinical studies.
Drives Bayer’s viewpoint inprioritization meetings on the future development of DataManagement Workbench (DMW)
Collaborates with peers within Data ManagementAcquisition & Review (DMAR) and DSA, ClinicalDevelopment, Clinical Sciences and the Oncology Business unitleadership teams to support and improve clinical compound and studyoperations and overall processdefinition / implementation
Liaises directly with managers / leaders of globalfunctions / activities to ensure effective teamwork and achievementof common goals.
Includes : DS&A, GCLs, ONC SBU or other TAgroups, Medical Experts, Regulatory Affairs, Clinical ProjectManagers (CPMs), Medical Writing, Medical Affairs, ClinicalSciences, Bayer Business Services (BBS)
Interactions with external interfaces : co-developmentpartners, auditors, inspectors, strategic sourcing partners, healthauthorities, industry and standards organizations
Who you are
Bachelor’s degree or Master’s degree withlong-term work experience or equivalent / higher; preferably in thefields of Natural Sciences, Life Sciences, Informatics or relatedsubject, e.
g. Statistics / Mathematics (Equivalent degrees such asstate certifications / graduations might also beaccepted)
Relevant healthcare long-term experience includingseveral years of Clinical Development experience in thepharmaceutical industry or a CRO
In addition several years of experience as line manager,or long-term experience as lead in major projectsProgram / process / change management experience
Technical background and knowledge of SQL, Oraclewarehouse principles, data acquisition applications, data modelprinciples and SAS
Technical Knowledge and Understanding about Clinical DataWarehouse requirements as it relates to systems and datainformation provision (Oracle Life Science Hub -
LSH, OraclePL / SQL, Oracle DM Workbench)
Experience leading cross function initiatives, includingpriority setting and timeline development
Strong understanding of business requirements offunctions / customers
Strong Communication skills to ensure that all system,process, and clinical data information plans aretransparent
Experience in Quality Assurance measures
Ability to embrace change and focus on continuousimprovement
Fluent English, written and spoken
Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people’s lives?
Then send us your online application including cover letter, CV and references.
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.
We are committed to treating all applicants fairly and avoiding discrimination.