Senior Project Manager, Data Management
- United States
- Clinical Data Management, Clinical Data Scientist Lead, Clinical Systems, Data Standards Consultant
- ICON Strategic Solutions
- Remote
TA Business Partner
- Icon Strategic Solutions
About the role
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As a Project Data Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
- At a program level, act as Data Management expert to develop data management strategies,
identify and implement methodologies and technologies to best support projects.
- Drive continual improvement across a program and effectively share lessons learned and best practices across projects/programs.
- Represent Clinical Data Management on the program governance teams / joint operations committees
- Manage the scope, budget, and resources for assigned projects/programs.
- Develop and maintain SOPs and working practice documents for data management tasks in collaboration with representatives from other functions and therapeutic areas.
- Proactively identify risks and executes risk mitigation strategies.
- Maintains timely communication with management and cross-functional teams.
- Establish and manage data capture, management, and review standards to ensure the quality and integrity of clinical research data in compliance with global regulatory requirements.
- Provide consultation, leadership, and expertise to clinical development functions in the areas of data handling and data management processes.
- Evaluate Electronic Data Capture (EDC) and other data collection technologies for implementation.
- Participate in the development and maintenance of standard eCRFs and associated edit specifications.
- Represent data management on key company initiatives.
- Participate in new hire process, onboarding activities, mentoring and training of DM staff.
- Line management and setting performance expectations for assigned direct reports.
- Other tasks as assigned.
You are:
- Demonstrated project management experience with ability to perform under tight timelines while balancing conflicting priorities
- Management skills to accomplish work through others and maintain appropriate relationships
- Experience working with and managing external service providers/vendors
- Working knowledge of data management process for clinical trials and current regulations
- Deep understanding of ICH GCP guidelines, CDASH standards, and other applicable regulatory rules and guidelines
- Strong organizational, time management, and resource-allocation skills with the ability to perform and prioritize multiple tasks and programs with excellent attention to detail
- Experience with regulatory audits and inspections
- Excellent communication, interpersonal, and presentation skills
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Application process
Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.
Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
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