Clinical Trial Manager I (Government)

Emmes•Rockville, WA

About The Position

The Clinical Trial Manager (CTM) I leads regional operational activities for one or more studies, tracking clinical-site progress and quality and overseeing the monitoring team and its deliverables. The CTM I oversees site management and monitoring activities, helps ensure study timelines are met, and communicates progress to the Project Leader or Global Clinical Project Manager. The role coordinates study implementation and clinical operations throughout the study lifecycle in accordance with corporate and project procedures, study plans, sponsor requirements, and applicable guidelines. It includes mentoring and overseeing CRAs and other site-management staff; managing study communications and meetings; contributing to study plans, templates, and protocol reviews; tracking site performance, risks, safety reporting, documentation, supplies, and investigational-product accountability; and identifying opportunities to improve operational practices and compliance.

Requirements

Bachelor's degree in a science-related field.
4–6 years of relevant clinical research experience; the posting also specifies 5 years as required.
1–3 years of experience as a CRA or in a clinical-operations coordinating role.
Knowledge of clinical research operations, including interpretation and implementation of country-specific regulations and ICH guidelines, as required.
Proficiency with the MS Office Suite.
Excellent team-building, interpersonal, organizational, analytical, verbal communication, and written communication skills.
Ability to prioritize and handle multiple tasks, work independently and in a complex team environment, and collaborate cross-functionally with limited oversight.
Strong computer and organizational skills, with high attention to detail.
Ability to work across varying projects and exercise critical thinking, problem solving, decision making, time management, and planning.
Self-motivation, adaptability, and ability to work effectively with internal and external colleagues in a team-oriented setting.

Nice To Haves

Master's degree in a science-related field.

Responsibilities

Maintain detailed knowledge of the study protocol, associated activities, and timelines.
Provide mentoring, training, and oversight for CRAs, in-house CRAs, and other site-management staff on assigned projects.
Coordinate and facilitate study implementation, managing tasks and overseeing clinical operations across study phases in accordance with SOPs, study plans, and sponsor requirements or guidelines.
Provide forecast projections to the GPM and track clinical-team overburn and underburn.
Establish and maintain working relationships with clients, vendors, and internal collaborators; communicate task status and updates to relevant internal and external collaborators.
Under the guidance of the Project Leader or Global Clinical Project Manager, potentially serve as the sponsor-facing contact for operational activities identified in the study Communication Plan.
Participate in or lead internal and external study calls and meetings.
Escalate study issues or concerns to line management and department leadership as needed.
Participate in developing and reviewing study plans, including the MOP, CMP, SOPs, pharmacy and lab manuals, and TMF plan; contribute to operational protocol review where applicable.
Participate in developing and reviewing study templates and materials, including master informed consent forms, participant-facing documents, site training materials, annotated visit reports, monitoring visit checklists, and monitoring correspondence.
Ensure study-site documents are current and ethics approvals are in place, as applicable.
Ensure CRA staff meet study timelines and deliverables, including monitoring plans and strategies, visit frequency, report submission and approval timelines, data collection timelines, and annotated reports, in line with the SOW and/or Emmes SOPs.
Evaluate operational practices and recommend process improvements to support ongoing regulatory compliance.
Maintain metrics for site assessment, feasibility and selection, activation, and closeout; track site performance and quality.
Monitor study progress at sites and identify risks, such as recruitment rates, missing data, investigational-product inventory and expiration, protocol compliance, safety reporting, and regulatory issues.
Stay informed about data-system progress and data-management activities; provide consultation as needed on protocol and operational guidelines, report development, data-collection requirements, and eCRF design.
Communicate frequently with the safety medical monitor to support adequate safety reporting in study documents and required reporting of safety events.
Track reporting and follow-up of Adverse Events, Serious Adverse Events, and Suspected Unexpected Adverse Events.
Manage study-level supplies and investigational-product or device accountability, coordinating with vendors as applicable.
Track study-documentation and archiving activities.
Conduct observational, training, and co-monitoring visits with CRAs as applicable.
Potentially assist with bid-defense preparation and conduct, RFP proposals, and DSMB/DMC coordination and management.
Perform other duties as assigned and comply with all policies and standards.