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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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