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Emmes · 22 hours ago

TEST - For Onboarding UX

Rockville, MD

Full-time

Onsite

Mid, Senior Level

4+ years exp

Emmes Group is a leader in clinical research, combining human intelligence with technology to advance healthcare. The Clinical Trial Manager I is responsible for overseeing operational activities for clinical studies, ensuring timelines are met, and managing site monitoring and relationships with clients and internal teams.

BiopharmaBiotechnologyClinical TrialsHealth CareMedical

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

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, 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. Contributes to operational review of the protocol if applicable

Participates in 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 study/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 or targeted 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

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

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

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

Qualification

Clinical research experienceRegulations/ICH guidelinesMS Office SuiteOrganizational skillsAnalytical skillsInterpersonal skillsCommunication skillsProblem-solving skillsCritical thinkingTime management

Required

Bachelor's Degree Required or

Master's Degree preferably in a science related field Required

4-6 years 5 years of relevant clinical research experience, including time as a CRA or in a clinical operations coordinating role Required

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