Clinical Trial Administrator
Boehringer Ingelheim
**Description**
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
The Clinical Trial Administrator (CTA) is responsible for assisting the IMP Delivery Program Leads (PL) and Trial Managers (TrM) in generating, tracking, and electronically filing work-related documents. CTA is responsible for initiating, managing and executing assigned standard tasks and ad-hoc assignments in a timely manner as agreed with the IMP Delivery Program Lead (PL) and Trial Manager (TrM). The CTA is responsible for effectively communicating with service providers and developing interfaces for all supply chain activities based on business, regulatory, and industrial requirements. The CTA ensures that all work is carried out safely and in accordance with country-specific regulatory requirements.
**Duties & Responsibilities**
**Cost estimation**
+ 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
**CTS Document Support**
+ 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
**TrM/PL Documentations Support**
+ 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.
**Close-Out and Destruction**
+ 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
**Active Comparator Evaluation and Ordering**
+ 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
**Trial Team Outsourcing**
+ 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
**Compensation Data**
The base salary range for this position is $60,000.00 to $97,000.00 USD. The position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. Actual compensation will be based on job-related factors such as skills, experience, and qualifications, and other factors permitted by law. For an overview of our benefits please click here. (https://www.boehringer-ingelheim.com/us/careers/explore-our-company/benefits-rewards)
**Requirements**
+ 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.
**Eligibility Requirements:**
+ 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
**Desired Skills, Experience and Abilities**
Working knowledge and experience with FoCUS Planisware and Veeva Vault systems
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
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