Clinical Study Manager (Raleigh, NC)

We are looking for a Clinical Study Manager (CSM) to coordinate and execute the operational and logistical aspects of clinical studies. This role will involve cross-functional collaboration both internally and with external partners to ensure clinical trial deliverables are achieved on time and within budget. The CSM will work closely with the Clinical Program Director and serve as a liaison with contracted vendors to manage vendor relationships, timelines, budgets, and troubleshoot project-level issues. Additionally, the CSM will support clinical development tasks critical to the successful execution of clinical trials.
 

• Coordinate and manage clinical trial and program deliverables from start-up through closeout activities, working cross-functionally with internal and external teams.
• Identify, mitigate, and resolve issues or delays in clinical study tasks while implementing contingency plans.
• Develop and maintain clinical project timelines using MS Project, including Gantt charts, and ensure integration with corporate timelines in collaboration with the project manager.
• Organize and facilitate project-specific meetings with cross-functional personnel or management.
• Oversee vendor and CRO activities, ensuring deliverables are on schedule and within budget.
• Prepare and present project reports for management and other stakeholders.
• Track and report study-specific metrics such as enrollment data, project milestones, and recruitment progress.
• Assist in designing, implementing, and revising clinical project plans and SOPs.
• Maintain study-specific documents, tools, and presentations, ensuring they are updated and retained appropriately.
• Collaborate on study data reviews, data monitoring activities, and periodic data review meetings.
• Provide strategic and operational input into study documents such as protocols, informed consent forms (ICFs), case report forms (CRFs), and study execution plans.
• Coordinate delivery and documentation of clinical trial supplies, ensuring site-specific needs are met.
• Support the CRO in planning and managing investigator meetings, including agenda development, presentation support, travel coordination, and meeting execution.
• Conduct site visits or attend CRO assessments to evaluate study progress and protocol compliance.
• Attend professional conferences and investigator meetings as needed.

• Bachelor’s degree in life sciences or a related field.
• At least 5 years of experience managing and executing clinical trials or clinical development programs, or an equivalent combination of education, training, and experience.
• Proficiency with Microsoft Office, including MS Project (highly recommended).
• Familiarity with CTMS and EDC systems, with basic knowledge of clinical monitoring and data management.
• Strong knowledge of ICH-GCP guidelines and applicable local and international industry regulations.
• Proven ability to work in a fast-paced environment, manage multiple priorities, and function both independently and within a team.
• Excellent organizational skills with the ability to set objectives, track progress, and implement mitigation strategies.
• Strong verbal and written communication skills for effective collaboration with multidisciplinary teams and management.
• Self-starter with an independent learning approach.
• Willingness to travel domestically up to 20%.

Department: Direct Clients
This is a full time position