IRT Functional Process Owner

IRT Functional Process Owner
Location: Warsaw, Poland

Hybrid work: 3 days per week in the office

Global Clinical Solutions (GCS)drives the delivery of Technologyand associated processesfor theBioPharmaceuticalsR&Dorganisation, owning and providing industry leading technology and services on behalf ofClinicalOperationsand its internal and external Partnerships.  

TheFunctional Process Owner (FPO)is a member of Global Clinical Solutions,GCS Technologiesdepartmentand isend-to-endresponsiblefor the leadership, lifecycle management and continuous improvement ofassigned system processes,guidelinesand user manuals.

The FPOworks closely withSystem Owner,vendor(s) if applicable,Business Process Management Office (BPMO),R&D IT (Information Technology),internal and externalcustomersand stakeholders to ensure customer needs are met and to enableoptimalend-to-end delivery of clinical studies. Responsible for the identification,definitionand delivery of improvements in end-to-end clinical study delivery, utilisingtoolsand techniques to achieve continuous improvement and value creation (i.e.,Lean Six Sigma). 

TheFPO ensures that thedefined system processes,guidelinesand user manualsmeetsAZ requirements,standards,bestpracticesandthey arein line with SOPs and other processes. The FPO collaborates closely with BPM Lead to confirm alignment of managed processes with overarching higher-level processes (e.g. SOPs).

TheFPOrepresentsthe business interests in strategy discussions andprovidesstrategic advice to the Governance team in securing long-term business successintheir assignedareas. Reviews and approves (if acceptable)identifiedsystem processrisks and mitigations. 

AllFunctional Process Ownerswill leadand manageimprovement projects asneeded,andwill contribute to functional and regional initiatives.

Typical Accountabilities

• Thelifecycle management -design, development, implementation, maintenance, continuous improvement- of the system processes for theallocatedarea

• Thedevelopment and delivery ofhigh qualityguidelines, user manuals,training materials, relevanttemplatesand toolkit documents

• Providing advice, training and end user support for the system processes and other system supporting documents

• Defining,trackingandmonitoringkey performance indicators of theallocatedsystem process, andusingthese data to informselectionofsystemprocess improvements and input to cross-functional improvements.

• The delivery of Corrective and Preventive Actions(CAPA)to time and quality, andforactingon data or trendsidentifiedthrough the Quality & Risk Management process. 

• Escalatingrisks and issues asrequired

• Ensure customer requirements are understood, critically evaluated,prioritisedand addressed within theallocatedsystem process areaand provide feedback and clear rationale for any areas that will not be addressed

• Engage and influence internal and external key stakeholders to drive thesystem processesstrategy,developmentand continuous improvementwithin theallocatedarea

• Liaise with relevant Process Owners, Business Process ManagementOfficeand Governance Team representatives to ensure alignment and cross-functional approach

• Liaise with relevant System Owner(s) to ensure that system processes and procedures are aligned

• Communicate and provide inputto Business Process Management Office and Process Owners forevaluation of newSOPsand regulationsrelated to the process.

• Be amember of Governance Teams relating to theallocatedarea

• Support audit and regulatory inspectionplanning,preparationand conduct. 

• Activelyseekand promote creative and innovative ideas to driveperformance and bringnew solutionsto customers.

• Understandsthesystemprocesses,technologyand servicesthe study teamrelies on, their needs and pain points. Usesthis knowledge toprovide advice and guidance,removesbarriers, providessolutionsandidentifiesopportunities for improvement

• Ensuresthe effective resolution ofsystemprocessrisks andissues that impede the Study Teamsprogress and effective delivery.Identifiesand engageswith the right process,technologyand service experts, and expertly utilisesescalation routes and governance bodies to gain traction and deliver rapid solutions

• Shares lessons learned and best practice recommendations with the Study Team and with GCS personnel to drive continuous improvement.

Education, Qualifications,Skillsand Experience

Essential:

• Bachelor of Science (BSc) inan appropriate disciplineor equivalent experience

• Extensiveexperience inDrug Developmentwithin a pharmaceutical or clinical background

• Strong business process, technology and ClinicalStudy information knowledge

• Strong operational knowledge of system processes in the clinical trial setting 

• Demonstrated project management skills and proven skills to deliver to time,costand quality

• Ability to work collaboratively, motivate and empower others toaccomplishindividual, team and organizational objectives

• Vendor Management - experience in working successfully and collaboratively with external partners delivering mutual benefit

• Demonstrated excellent written and verbal communication and influencing skills, negotiation, collaboration, problem solving, presentation, knowledge transfer (mentoring), conflictmanagementand interpersonal skills.

Desirable:

• Expert reputation within the business and industry

• Experience ofutilizingstandard process improvement methodologies (e.g., Lean Six Sigma) toidentifyroot causes of process issues andidentifyareas of process improvement

• Experience in the development and management of Business Processes to deliver business performance

• Comprehensive knowledge of ICH/GCP

• Extensive experience in Validation of computerised systems in a regulated environment, preferably thePharmaceuticalindustry, including familiarity with documentation such as Validation Plans, Reports, Test scripts etc. and knowledge of regulatory (GxP, SOX,etc.) requirements for computerised systems and infrastructure

• Extensive experience of Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment.