The Project Manager is the hub of study operations and communication.
The Lotus team operates as an extension of the sponsor’s team.
Project Management
The advanced models necessary for rapid recruitment and reliable results.
Lotus Clinical Research Project Managers are the cornerstone of a successful trial
Lotus Clinical Research provides skilled project managers with an average tenure of 10+ years in the industry. Our project managers drive operational efficiency through strong leadership skills and innovative problem solving. Being a right sized CRO, you will find our team is dedicated to your trial and responsive to your needs in ways that can be hard to find at the larger CROs. Our project managers are nimble and innovative, leading the Lotus team to seamlessly function as an extension of your team.
Lotus’ focus is to lead your study to an on-time completion with the highest quality data to support your project and company goals. Key to many studies, our project managers are highly effective at rapid study startups. By leveraging Lotus Clinical Research’s expertise, site relationships, effective tools, and collaborative approach, many projects have been activated in as little as two months. The Lotus team utilizes integrated Veeva Vault modules such as CTMS, eTMF, and EDC to make the management of your trial more seamless.
We are committed to delivering your project on time and budget, with an uncompromising focus on quality and compliance. We apply time-honored project management principles to effectively meet the timelines of your project, using standardized processes and optimizing lines of communication.
As your primary point of contact, your Lotus Clinical Research Project Manager will lead your study including:
- Timeline development and management
- Team leadership and communication
- Protocol and Informed Consent Form (ICF) development
- Study plan development
- Site selection
- Risk identification and mitigation
- Vendor management
The Lotus Clinical Research project manager is the cornerstone of a successful program.
Lotus Clinical Research provides skilled project managers that are well suited to the needs of analgesic and CNS trials. With an average tenure of 10+ years in the industry, our project managers have considerable experience in pain trials, with a focus on leading studies to on-time completion with the highest quality data to support regulatory submissions.
Our project managers are highly effective at rapid startups. By leveraging ERG site relationships from final protocol to first patient in, projects have been activated in as little as six weeks.
We apply classic project management principles to effectively meet timelines and project milestones by optimizing lines of communication. Our project managers will seamlessly function as an extension of your team from protocol development through delivery of the Clinical Study Report (CSR).
As your single point of contact, the project manager will lead your study in:
- Timeline development and management
- Protocol and Informed Consent Form (ICF) development
- Study plan development
- Patient reported outcome diary development
- Site selection
- Vendor management
- Recruitment strategies for targeted populations
- Risk mitigation: includes identification, analysis, response, and quality control
- Monitor and site performance management
- Study team, Clinical Research Associates and clinical sites communication
