Clinical Trial Administrator jobs in United States
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Boehringer Ingelheim · 11 hours ago

Clinical Trial Administrator

Boehringer Ingelheim is a global leader in pharmaceuticals, dedicated to improving the lives of patients. The Clinical Trial Administrator will assist in managing clinical trial documentation, support trial managers with cost estimation, and ensure compliance with regulatory requirements.

BiotechnologyHealthcarePharmaceuticalHealth CareMedical
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Comp. & Benefits
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Responsibilities

Assists Trial Managers (TrM) and Program Leads (PL) in entering and updating study and program costs into the Cost Estimate System (CES)
Execution of monthly reports, making entries as needed
Drafts CTS documents and submits them to the TrM for review and approval
Forwarding of CTS documents for review by the Clinical Trial Manager (CTL) and, depending on the document, additionally to other responsible persons
Archives approved CTS documents in electronic Management System
Assists in managing and editing workflows in eDMS (e.g. P310)
Performs FoCUS entries/updates and the insertion of templates (e.g. resupplies, studies (early detailing)) in consultation with the PL/TrM
Prepares Manual shipping requests/Bulk Order and Manufacturing Requests in consultation with the PL
Manual Shipment Request for Bulk Shipments and Stability Samples
Completes sampling documents for investigational medicinal products
Takes over and coordinates the processing of the close-out process in the trial team
Scheduling trial team meetings or informing trial team members directly about the tasks relevant to the close-out
Preparation of the documents to be archived and transfer of the complete close-out folder for archiving
Coordinates and ensure the timely destruction of expired bulk and trial material
Coordinates the request of the Active Comparator Evaluation to the respective development disciplines
Keeps the PL informed of delays in responses from the development disciplines
Assists the PL in ordering comparator view samples and the appropriate amount of comparator products required to conduct the respective clinical trials
The CTA places the completed Active Comparator Evaluation forms in the appropriate comparator supplement folder for the therapeutic area upon request year and saves the Active Comparator forms in the "In-Process" file in internal Systems
Coordination of Comparator Ordering
Generation of Purchasing Orders for Trial Management costs
Manages Document Management for Trial Team oursourced trials in different eDMS
Initiates and Reviewes cost estimation for Trial Team oursourced trials
Keeps Cost estimation and Resources for Trial Team outsourced trials on track
Maintains FoCUS entriesor Trial Team outsourced trials on track

Qualification

USEU regulationsProject Management SoftwareMicrosoft Office 365FoCUS PlaniswareVeeva VaultRisk assessmentsTroubleshootingBasic project managementProblem solvingWritten communicationVerbal communication

Required

Bachelor's-Degree with some years experience in a relevant area
Broad and thorough knowledge and understanding of applicable US and EU regulations and other international regulations
Strong computer skills (e.g. Microsoft Office 365, Project Management Software)
Basic project management skills
Proven ability to drive results in a changing environment and to discuss and present proposals in a concise and effective manner
Ability to interpret standard project requirements
Good problem solving, risk assessments and troubleshooting skills
Excellent written and verbal communication skills. Demonstrated ability to present projects / status reports to different audiences
Onsite/Flex: This position is site based with flexibility for remote working. Working onsite a minimum of 2-3 days per week is required. Remote working norms will be clarified during the interview process
Willingness to travel
Must be legally authorized to work in the United States without restriction
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older

Preferred

Working knowledge and experience with FoCUS Planisware and Veeva Vault systems

Benefits

Role specific discretionary bonus
Relocation
Other compensation elements

Company

Boehringer Ingelheim

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Boehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim.

Funding

Current Stage
Late Stage

Leadership Team

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Christian Eckermann
Corp. SVP BioPharma Network
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Clemens Twardy
Corporate Vice President, Head of Global Supply Chain and Lifecycle Management Animal Health
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Company data provided by crunchbase