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Emmes · 13 hours ago

Clinical Trial Manager II

United States

Full-time

Remote

Senior Level

7+ years exp

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. The Clinical Trial Manager II is responsible for executing operational activities for clinical studies, leading monitoring teams, and ensuring timelines are met while maintaining strong relationships with clients and collaborators.

BiopharmaBiotechnologyClinical TrialsHealth CareMedical

Responsibilities

Possesses detailed knowledge of the study/protocol and its associated activities and timelines, leverages operational expertise to design operational strategy for trial execution

Provides mentoring, training, and independent oversight for in-house Clinical Research Associates (CRAs), CRAs, and site management staff on assigned projects

Leads operational 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

Establishes and maintains strong working relationships with clients, vendors, and internal collaborators

Communicates with internal and external collaborators regarding status of tasks and updates and is responsible for communication of status of activities to internal teams

Under the guidance of the Project Leader/Global Clinical Project Manager, serves as the client/sponsor-facing point of contact for operational activities as outlined in the study’s Communication Plan

Leads internal and external operational study calls and meetings, participates in other calls as required

Escalates issues or concerns regarding study activities to line management and the department leadership as needed

Leads 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

Provides operational review of the protocol if applicable

Leads the development and review of key templates such as master informed consent form(s) 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 site document currency and ethics approvals, as applicable

Ensures study timelines and deliverables are met by CRA staff, including, but not limited to, development of the clinical monitoring plan per the Statement of Work (SOW), evaluation of the risk-based monitoring strategy, monitoring visit frequency, monitoring visit report submission/approval timelines, study data collection timelines, and the annotated reports per the project SOW and/or Emmes SOPs

Continuously evaluates current operational practices and recommends process improvements to ensure continued compliance with regulatory requirements and industry best practices

Develops and maintains metrics related to site assessments, feasibility and selection, site activation and close out activities

Tracks and reports on site performance metrics and quality

Stays up to date on overall study progress at the site(s) and proactively identifies and escalates risk (e.g. recruitment rates, missing data, investigational product inventory and expiration, protocol compliance, safety reporting, regulatory issues, etc.) while providing risk mitigation strategies

Remains informed of data system progress and data management activities; may serve in a consultative role as it relates to the study protocol and operational guidelines, report development, data collection requirements, eCRF design, etc

Maintains frequent communication with the safety/medical monitor to ensure adequate safety reporting information is included in key study documents (e.g., protocol, informed consent form) and that safety event reporting is occurring as required

Tracks reporting and follow-up of Adverse Events, Serious Adverse Events, and Suspected/Unexpected Adverse Events

Responsible for study-level supplies and investigational product/device accountability, including coordination with vendors as applicable

Tracks documentation and archiving of study documents

Conducts observational, training, and co-monitoring visits with CRAs as applicable

Assists with bid defense preparation and conduct and in the RFP/proposal process

May assist with DSMB/DMC coordination and management

Other duties as assigned

Qualification

Clinical research operationsRegulatory complianceProject managementMS Office SuiteTeam buildingAnalytical skillsCommunication skillsProblem-solving skillsCritical thinkingTime management

Required

Bachelor's or a master's degree, preferably in a science related field

Incumbent will typically possess at least 7-8 years of relevant clinical research experience, including time as a CRA or in a clinical operations coordinating/leadership role

Excellent team building and interpersonal skills

Excellent organizational and analytical skills

Excellent verbal and written communication skills

Excellent ability to prioritize and handle multiple tasks

Ability to work independently, as well as in a complex team environment

Proficient with MS Office Suite

Excellent computer and organizational skills

High attention to detail required

Ability to work on varying projects and exercise critical thinking

Self-starter who can work independently and a team player who can work cross functionally with limited oversight

Knowledgeable in clinical research operations, including interpretation and implementation of country-specific regulations/ICH guidelines, as required

Excellent organizational, interpersonal, and communication skills (both oral and written)

Demonstrated problem-solving skills, self-motivated, and adaptable to a dynamic environment

Knowledgeable in prioritization, problem-solving, organization, critical thinking, decision-making, time management, and planning activities

Ability to collaborate with internal and external colleagues and work well in a team-oriented setting