Clinical Trials Manager/Senior Clinical Trials Manager

3 weeks ago

Chicago, United States Exicure, Inc. Full time

The Clinical Trials Manager/Senior Clinical Trials Manager is responsible for planning, executing, and monitoring a clinical study or studies and ensuring an on time and on budget completion. The Clinical Trials Manager/Senior Clinical Trials Manager will lead a cross-functional team and serve as a primary resource and point of communication for vendors.

Responsibilities include but are not limited to the following:

* Execute clinical trials from protocol design to clinical study report.
* Oversee vendors and ensure the efficient and effective management of contracted services.
* Conduct study closeout activities.
* Drive the identification, selection and contracting of vendors including creating Request for Proposals (RFPs) and coordinating bid defense meetings.
* Generate a comprehensive and detailed study-specific timeline/project plan.
* Lead internal cross-functional meetings.
* Coordinate the activities of functions and vendors including, but not limited to: Clinical Research Organizations (CROs), labs, regulatory, medical writing, data management, statistics, medical monitoring, and safety to insure proper conduct and timely completion of studies.
* Identify risks and implement strategies to monitor and mitigate risks and ensure successful study completion.
* Ensure adherence to contracts, manage scope change and monitor budgets.
* Provide study status reports to management and escalate issues as appropriate.
* Follow applicable Standard Operation Procedures (SOPs).
* Ensure compliance with applicable Good Clinical Practices (GCPs), identify issues early, implement appropriate corrective actions and ensure audit readiness.
* Monitor study team member performance and identify resourcing needs.

Qualifications

* Advanced knowledge of and ability to apply and all applicable regulations and guidelines including GCP.
* Pharmaceutical and/or clinical drug development experience required.
* 7-10 years of clinical research experience as a Project Manager/ Clinical Trials Manager /Study Manager at a CRO and/or Sponsor. Title will be determined based on level of experience.
* Excellent organizational and time management skills.
* Must have proven leadership, written and verbal communication skills, and computer competency.
* Must be able to work independently and in a team environment to effectively lead and drive the project deliverables.

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