
Global Trial Manager (Early Development)
Welcome to Amgen, a leading global biotechnology company dedicated to discovering, developing and delivering innovative medicines to patients in need. As a Global Trial Manager for our Early Development team, you will play a crucial role in the success of our clinical trials by overseeing the planning, execution, and management of global clinical trials. We are seeking a highly motivated and experienced individual who is passionate about making a difference in the lives of patients and has a strong background in clinical trial management. If you have a proven track record of successful trial management, excellent project management skills, and the ability to collaborate effectively with cross-functional teams, we would love for you to join our team.
- Oversee the planning, execution, and management of global clinical trials for the Early Development team.
- Coordinate with cross-functional teams to ensure successful implementation and completion of clinical trials.
- Develop and maintain trial timelines, budgets, and resources.
- Identify potential risks and develop contingency plans to mitigate them.
- Ensure compliance with all relevant regulations and guidelines.
- Collaborate with internal and external stakeholders to ensure efficient trial processes.
- Manage trial contracts, budgets, and payments to vendors and investigators.
- Monitor trial progress and provide regular updates to management.
- Lead trial meetings and communicate trial updates to team members.
- Develop and maintain relationships with key opinion leaders, investigators, and study sites.
- Ensure data quality and integrity through appropriate review and monitoring.
- Train and mentor junior team members on trial management processes.
- Participate in the development and implementation of standard operating procedures.
- Stay up-to-date on industry trends and best practices in clinical trial management.
- Represent Amgen at conferences and other external events related to clinical trials.
Extensive Experience In Clinical Trial Management: A Qualified Global Trial Manager Must Have A Minimum Of 5 Years Of Experience In Managing Clinical Trials, Preferably In Early Development Phases. This Includes Experience In Designing And Executing Clinical Trial Protocols, Managing Timelines And Budgets, And Ensuring Compliance With Regulatory Guidelines.
Strong Knowledge Of Global Regulatory Requirements: Amgen Operates In Multiple Countries And Regions, Making It Essential For A Global Trial Manager To Have A Thorough Understanding Of Global Regulatory Requirements. This Includes Knowledge Of Ich-Gcp Guidelines, Local Regulations, And Ethical Standards For Conducting Clinical Trials.
Project Management Skills: The Role Of A Global Trial Manager Requires Excellent Project Management Skills. This Includes The Ability To Plan, Organize, And Execute Multiple Projects Simultaneously, While Ensuring Timely Delivery And High-Quality Results. A Qualified Candidate Should Also Have Experience In Managing Cross-Functional Teams And Vendors.
Scientific And Technical Expertise: As A Global Trial Manager, It Is Crucial To Have A Strong Scientific And Technical Background, Especially In The Field Of Early Development. This Includes A Thorough Understanding Of Drug Development Processes, Clinical Trial Design, And Data Analysis. A Background In Life Sciences, Pharmacy, Or Medicine Is Preferred.
Excellent Communication And Leadership Skills: Amgen Values Effective Communication And Strong Leadership Skills In Its Global Trial Managers. A Qualified Candidate Must Be Able To Effectively Communicate With Internal And External Stakeholders, Including Study Investigators, Regulatory Authorities, And Team Members. They Should Also Possess Strong Decision-Making Abilities And The Ability To Lead And Motivate Their Team Towards Achieving Project Goals.
Project Management
Vendor Management
Data Analysis
Budget management
Risk assessment
Regulatory compliance
Clinical trial management
Cross-Functional Collaboration
Protocol Development
Site Selection
Pharmaceutical Industry
Communication
Conflict Resolution
Leadership
Time management
Interpersonal Skills
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Global Trial Manager (Early Development) in Washington, DC, USA is $110,000 - $145,000 per year, with a median salary of $127,500. This may vary depending on factors such as experience, qualifications, and the specific company and industry.
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Amgen Inc. is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California.

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