[Hiring] Clinical Trial Manager I @Emmes

Role Description

The Clinical Trial Manager (CTM) I is responsible for the leadership of operational activities for a study or group of studies at a regional level, including tracking progress and quality at clinical sites. The CTM I will oversee the monitoring team and associated deliverables, including the clinical monitoring plan, site visit reports, etc. In addition, the CTM I works to ensure clinical trial timelines are being met and communicated to the Project Leader/Global Clinical Project Manager. The CTM I will oversee site management and site monitoring activities.

Responsibilities

• Possesses detailed knowledge of the study protocol and its associated activities and timelines.
• Provides mentoring, training, and oversight for Clinical Research Associates (CRAs), in-house CRAs, and other site management staff on assigned projects.
• Coordinates and facilitates implementation of a study, including management of tasks and oversight of clinical operations activities specific to each phase of the study lifecycle in accordance with corporate and project level Standard Operating Procedures, study plans, and any client sponsor requirements or guidelines.
• Provide forecast projections to GPM and track clinical team overburn/underburn.
• Establishes and maintains strong working relationships with clients, vendors, and internal collaborators.
• Communicates with internal and external collaborators regarding status of tasks and updates.
• May serve as the client sponsor facing point of contact for operational activities as outlined in the study's Communication Plan.
• Participates in or leads internal and external study calls and meetings.
• Escalates issues or concerns regarding study activities to line management and the department leadership as needed.
• Participates in the development and review of key study plans such as the Manual of Procedures (MOP), Clinical Monitoring Plan (CMP), Standard Operating Procedures (SOPs), pharmacy lab manuals, TMF plan, etc.
• Participates in the development and review of key templates such as master informed consent forms and other participant facing documents, site training materials, annotated report for each visit type conducted for the study, monitoring visit checklists, monitoring correspondence documents, etc.
• Responsible for ensuring study site document currency and ethics approvals, as applicable.
• Ensures study timelines and deliverables are met by CRA staff.
• Evaluates current operational practices and recommends process improvements to ensure continued compliance with regulatory requirements.
• Maintains metrics related to site assessments, feasibility and selection, site activation and close out activities.
• Tracks site performance metrics and quality.
• Remains informed of data system progress and data management activities.
• Maintains frequent communication with the safety medical monitor to ensure adequate safety reporting information is included in key study documents.
• Responsible for study level supplies and investigational product device accountability.
• Tracks documentation and archiving of study documents.
• Conducts observational, training, and co-monitoring visits with CRAs as applicable.
• May assist with bid defense preparation and conduct or in the RFP proposal process.
• May assist with DSMB/DMC coordination and management.
• Performs other duties as assigned.
• Complies with all policies and standards.

Qualifications

• Bachelor's Degree in a science-related field. Required.
• Master's Degree in a science-related field. Preferred.
• 4-6 years (5 years) of relevant clinical research experience. Required.
• 1-3 years of experience as a CRA or in a clinical operations coordinating role. Required.
• Excellent team building and interpersonal skills. High.
• Excellent organizational and analytical skills. High.
• Excellent verbal and written communication skills. High.
• Excellent ability to prioritize and handle multiple tasks. High.
• Ability to work independently, as well as in a complex team environment. High.
• Proficient with MS Office Suite. High.
• Excellent computer and organizational skills. High.
• High attention to detail required. High.
• Ability to work on varying projects and exercise critical thinking. High.
• Self-starter who can work independently and a team player who can work cross-functionally with limited oversight. High.
• Knowledgeable in clinical research operations, including interpretation and implementation of country-specific regulations and ICH guidelines, as required. High.
• Demonstrated problem-solving skills, self-motivated, and adaptable to a dynamic environment. High.
• Knowledgeable in prioritization, problem-solving, organization, critical thinking, decision making, time management, and planning activities. High.
• Ability to collaborate with internal and external colleagues and work well in a team-oriented setting. High.

Company Description