Project Manager - Technical - Italy
Social network you want to login/join with: Project Manager - Technical - Italy, Milan Client: Thermo Fisher Scientific Location: Milan, Italy Job Category: Other EU work permit required: Yes Job Reference: 433c0535d028 Job Views: 10 Posted: 13. 02. 2025 Expiry Date: 30. 03. 2025 Job Description: At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale.
Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.
We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.
This role will be embedded within a client dedicated team.
You will work alongside the client's own experienced personnel, as well as PPD colleagues to deliver innovative clinical support.
Discover Impactful Work: Provides quality oversight to the Contract Research Organization (CRO) and of the CRO deliverables related to study execution.
Leads and coordinates the execution of a clinical trial from Study start-up through Database close and inspection readiness to ensure timely delivery of quality study data.
Provides leadership to the teams in the setting of realistic recruitment targets and delivery milestones.
Works with functional lines and directly with CRO line functions to resolve or triage site level issues.
Drives decision making and works closely with the Clinical Project Manager to provide input to operational strategy.
May act as 'lead' study manager and will coordinate activities of the other Study Managers assigned.
A Day in the Life: Ability to drive software, AI, Automation or Data Analytics project implementation in R&D. Global responsibility for all study management aspects of assigned studies.
Playing a key role in planning project milestone delivery and driving change management.
Delivering innovative solutions to advance R&D. Accountable for the development of realistic detailed study startup and monitoring plans.
Accountable for conducting country level feasibility in collaboration with Global Clinical Trial Execution and CROs.
Leads study risk planning process in context of site and subject.
Develops and provides key inputs to Clinical Trial Budget.
Leads inspection readiness activities related to study management and site readiness.
May produce or review model Informed Consent Document (ICD) and study/country/site level ICD.
Keys to Success: Education: MS/PhD – minimum of 3 years of proven experience.
BS/Nurse – minimum of 5 years of proven experience.
Extensive global clinical trial/study management experience.
Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations.
Experience: Expertise in one or various tech areas, specializing in driving innovation and efficiency through technology.
Demonstrated study management/leadership experience.
Demonstrated oversight of CROs.
Demonstrated experience in managing Per Subject Costs, vendor & ancillary, and monitoring costs projections & spend.
Knowledge, Skills, Abilities: Understands how to work with vendors to accomplish tasks.
Ability to interpret study level data & translate and identify risks.
Ability to proactively identify & mitigate risks around site level in study execution.
Understands feasibility of protocol implementation.
Country level cultural awareness and strong interpersonal skills.
Keen problem-solving skills.
Excellent communication skills, both written and verbal.
Must be fluent in English.
Detail oriented & possesses technical expertise (spreadsheets, metrics & data flow management).
Our Mission is to enable our customers to make the world healthier, cleaner and safer.
As one team of 100, 000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement.
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