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*Senior Global Trial Manager Germany* - (1724676) in Germany at IQVIA™

Date Posted: 2/13/2018

Job Snapshot

Job Description

Join us on our exciting journey!

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
Contributes, with appropriate oversight, to all aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team.
 
Contributes to all operational trial deliverables, under the oversight of the (Associate) Global Trial Director, according to timelines, budget, operational procedures, quality /compliance and performance standards. Assigned responsibilities can include but are not limited to:
• Development of specific sections of the protocol and related documents;
• Development of study tools, guidelines and training materials;
• Organization and logistics of various trial advisory committees
• Ensuring trial information/results are reported within relevant trial repositories and tracking systems
•  Contributing to the development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review reports and trial statistical analysis plan in collaboration with the trial data manager, trial statistician, statistical programmer and clinical development representative;
• Implementing issue resolution plans;
• Acting as point of contact for all site-related issues and procedural questions;
• Managing interactions with relevant line functions including data management, drug supply management and clinical development
• Ensuring proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation
 
Resource Management:
• Supports the Global Trial Director with the development, management and tracking of the trial level life cycle budget incl. forecast, and annual cost targets.
 
Core member of the global cross-functional Clinical Trial Team (CTT); participate and report study progress and issues/resolution plan at the CTT meeting; write CTT meeting minutes. Organize and chair trial sub teams within the scope of his/her delegated responsibilities. Extended member of the Global Clinical Team (GCT).
 
As member of the CTT, contribute to defining the Data Review Plan; participate in data review as specified in the Data Review Plan.
 
May contribute to talent development through active participation in onboarding and training activities.
 
May participate in GDO Trial Management initiatives and working groups.
 
 
Responsible for education, implementation and compliance to standards (SOPs) and best practices for trial management within assigned clinical trial(s) and within clinical program(s) and franchise, including sharing lessons learned.

Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
• Strong knowledge of clinical research financial parameters and project financial tracking and accounting methods
• Strong leadership skills
• Effective presentation skills
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
• Strong written and verbal communication skills including good command of English
• Excellent organizational and problem solving skills
• Effective time management skills and ability to manage competing priorities
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
 
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in a health care or other scientific discipline or educational equivalent; minimum 4 years of experience in clinical development. Involvement in cross-functional, multicultural and international clinical trials; demonstrated capabilities in supporting operational aspects of clinical trial related activities; or equivalent combination of education, training and experience.

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.



Job ID: 1724676

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