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Simbec-Orion · 2 days ago
Project Director
United States
Full-time
Remote
Director
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Responsibilities
Acts as the primary point-of-contact and liaison with the Sponsor to provide outstanding customer service and serves as an ambassador to promote Simbec-Orion’s high quality and ethical image.
Leads and manages the cross-functional project teams.
Communicates with internal Department Heads and Senior Management to evaluate study needs, resources and timelines.
Manages contractual project deliverables, agreed timelines, quality/scope and cost, including monitoring progress via metrics.
Develops appropriate study management plans in collaboration with service leads.
Proactively manages risks and resolves issues.
Manages vendors who provide services to support the projects. This includes identification of vendors, obtaining quotes for the scope of their work and managing this work as per the agreed contract.
Manages and reports project finances including management of out of scope activities as per Simbec-Orion processes.
Prepares presentation slides for Project Management aspects and co-ordinates delivery of presentation slides from the cross-functional project team for Bid Defence meetings. At the Bid Defence meetings actively contributes to the discussions and presents slides as agreed at the internal preparation meeting.
Acts as a "buddy" for new team members joining Simbec-Orion.
Qualification
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Required
Degree or equivalent level qualification in life sciences / related area or equivalent combination of education, training and experience.
Experience of managing several full service projects with a minimum of 3 services within a Clinical Research Organisation (CRO).
Global experience with managing global Phase I-III patient studies from set-up to close-out.
Strong communication skills with the ability to present in fluent English.
In depth knowledge of, and skill in applying ICH-GCP guidelines and any other applicable clinical research regulatory requirements.
Fully experienced with using tools such as eTMF and CTMS.
Expert knowledge of project finances that includes revenue recognition and forecasting of professional fees.
Highly motivated and able to work and plan independently and in a team environment.
Ability to solve challenging problems balancing facts and logic i.e. handling difficult requests or complaints.
Able to input into the strategy for new business.
Preferred
Line management experience.
Experience in managing Rare & Orphan Diseases clinical studies.
Experience in managing early phase Oncology dose escalation clinical studies.
Experience in adaptive design studies.
Intermediate experience with MS Project or other Project Management software.
Company
Simbec-Orion
Simbec-Orion provides clinical trial management services for therapeutic indications and phases.
Founded in 1997
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Fabrice Chartier
Group Chief Executive Officer
Company data provided by crunchbase
