Clinical Systems Project Associate

Requisition Number: 1999

Position Title: Clinical Systems Project Associate

External Description:

The Clinical Systems Project Associate supports clinical systems and studies, and assists project managers, ensuring high quality execution of projects. Performs general administrative tasks.
 
 
RESPONSIBILITIES:
Tasks may include but are not limited to:

• Work with and assist project managers on the development and support of clinical systems and studies
• Assist with the creation of project documents
• Assist with the development and maintenance of training courses
• Assist with the tracking of training as required for Worldwide, vendor, and study and site personnel
• Assist project managers with project communications, including the development of study status reports, meeting minutes and agendas and scheduling of calls
• Assist project managers with tracking deliverables and milestones, financial tracking, records retention and Trial Master File management
• Prepare support and helpdesk documentation
• Assist with User Acceptance Testing when required
• Perform quality checks on validation documentation
• Provide first-line and second-line support where appropriate to clinical systems supported by the Clinical Systems Department
• Respond to and resolve support requests, including monitoring and following up on outstanding support requests to meet Service Level Agreements
• Advise project manager of any ongoing or repeat support issues
• Make data updates directly in clinical systems in alignment with SOPs relevant for that system
• Perform database edits, drug management tasks, and other support accurately and efficiently to ensure the smooth operation of services and rapid issue resolution to meet SLAs
• Provide Quality Control checks on database edits, drug management tasks, and other support tasks that require checks for tasks completed by vendors or other Worldwide personnel
• Contribute to incident management
• Maintain and control access to various systems for both in-house and vendor systems
• Fully cooperate with auditors or regulatory authority inspectors before, during and after projects as applicable
• Participate in process and quality improvement efforts to increase overall operational efficiency
• Monitor study execution to ensure correct randomization and kit assignment function
• Ensure that all activities are appropriately documented and stored in accordance with the relevant SOP and requirements of the client company
• Perform other duties as assigned

 
OTHER SKILLS AND ABILITIES: 

• A good standard of written and spoken English
• Proficient in the use of common office software
• Self-motivated individual who can positively contribute to a team environment
• Able to work independently or in a multi-disciplinary team
• High attention to detail
• Ability to prioritize and handle multiple projects simultaneously

 
REQUIREMENTS:

• Educated to degree level in a relevant discipline or able to demonstrate equivalent experience
• 0-2 years experience within a clinical trial environment or pharma industry.

 #LI-HD1

City:

State: North Carolina

Employment Type: Regular

Community / Marketing Title: Clinical Systems Project Associate

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Research Triangle Park (RTP), North Carolina US

CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.