Rubrik:

Produkter:

Scrum,Agile,SAFe,DevOps,GxP,SOX

Roller:

Projektledare

Distrikt:

Gbg

Beskrivning:

As the Study onboarding Projekt Manager you will lead the trial onboarding team and process for one or several clinical trials and report project status and progress to the Trial Onboarding Lead and IT Program lead. You will; determine the implementation approach, define the critical path and appropriate implementation roadmap for bringing digital solutions to clinical trials. • Develop and maintain detailed project plans and track and manage the activities, milestones and plans involved in delivering digital solutions to clinical trials • Co-ordinate the work of stakeholders and project team members involved in the onboarding clinical trials • Co-ordinate and manage the dependencies between the core product development lifecycle, trial onboarding milestones and external (business and technical) dependencies • Ensure that the project team and the technical solution delivered fulfils the requirements of the clinical trials and adheres to all standards including project methodologies, quality, and compliance, as well as processes, defined technical capabilities, and best practices • Further develop the process of delivering solutions to clinical trials and identify and implement process improvements • Ensure effective risk & issue management. Resolve problems and escalate as appropriate • Manage changes to requirements/time & scope, ensuring that all impacts and changes are approved, planned for and appropriately communicated to stakeholders • Develop service transition plans to ensure the digital solutions are sustained within a BAU operations environment, including the controlled hand-over into operational support of the digital solution for a clinical trial. Required skills & experience: • 10+ years of project management experience with a strong technical background, ideally in a pharmaceutical IT environment • Validated skills and experience in leading and delivering large and complex projects/programmes • Proven experience in detailed project planning including creating WBS, milestone plans and dependency plans • Experience of working with globally distributed and cross-functional teams and stakeholders • Proven understanding of quality and compliance • Strong customer and delivery focus • Strong interpersonal skills and experience in mentoring/coaching others within the programme • Ability to work collaboratively, motivate and empower others to accomplish individual, team and project objectives • Experience of leading and managing change in a complex environment • Experience in requirements management and technical negotiations across complex stakeholder groups • High level of drive, energy and resilience • A sense of ownership and leadership in delivering high quality solutions • The ability to occasionally travel both domestically and internationally • Fluency in English Desired skills & experience: • Experience with SAFe, Scrum, DevOps and agile ways of working in general • Experience in validation of computerized systems in a regulated environment, preferably the pharmaceutical industry, 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 including software as a medical device (SaMD) • Understanding of the clinical trial process Education/Experience: • Relevant degree Location: Gothenburg, Sweden Language: Fluent English

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