Clinical Trial Manager I (Government)

Emmes Group•Rockville, MD

10d

About The Position

The Clinical Trial Manager I leads regional operational activities for one or more clinical studies, tracking progress and quality at clinical sites. The role oversees the monitoring team and associated deliverables, including clinical monitoring plans and site visit reports, and helps ensure that study timelines are met and communicated to the Project Leader or Global Clinical Project Manager. The position also oversees site management and monitoring activities. The CTM I coordinates study implementation and clinical operations across the study lifecycle in accordance with corporate and project-level SOPs, study plans, and sponsor requirements. The role works with CRAs and other site-management staff, clients, vendors, and internal collaborators; monitors site performance, quality, risks, timelines, and deliverables; and contributes to study plans, templates, regulatory compliance, safety reporting, and study documentation. Under guidance, the CTM I may serve as the operational point of contact for the client sponsor. The position may also support bid defenses, proposals, and DSMB/DMC coordination.

Requirements

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

Nice To Haves

Master’s degree in a science-related field (preferred).

Responsibilities

Maintain detailed knowledge of the study protocol and associated activities and timelines.
Mentor, train, and oversee CRAs, in-house CRAs, and other site-management staff on assigned projects.
Coordinate study implementation and oversee clinical operations activities throughout each study phase, following applicable SOPs, study plans, and sponsor requirements.
Provide forecast projections to the GPM and track clinical team overburn and underburn.
Build and maintain working relationships with clients, vendors, and internal collaborators; communicate task status and activity updates.
Under guidance from the Project Leader or Global Clinical Project Manager, serve as the sponsor-facing point of contact for operational activities as outlined in the study Communication Plan.
Participate in or lead internal and external study calls and meetings.
Escalate study activity 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 when applicable.
Participate in developing and reviewing study templates and materials, including informed consent forms, participant-facing documents, site training materials, annotated visit reports, monitoring checklists, and correspondence documents.
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 accordance with the SOW and applicable SOPs.
Evaluate operational practices and recommend improvements to maintain regulatory compliance.
Maintain metrics for site assessment, feasibility and selection, activation, and closeout activities.
Track site performance and quality; monitor study progress and identify risks such as recruitment, missing data, investigational product inventory or expiration, protocol compliance, safety reporting, and regulatory issues.
Stay informed about data systems and data management; provide consultation as needed on protocol and operational guidelines, reporting, data-collection requirements, and eCRF design.
Communicate frequently with the safety medical monitor to ensure safety reporting requirements are reflected in study documents and followed; track reporting and follow-up of AEs, SAEs, and SUSARs.
Manage study-level supplies and investigational product/device accountability, including vendor coordination as applicable.
Track study documentation and archiving.
Conduct observational, training, and co-monitoring visits with CRAs as applicable.
May assist with bid-defense preparation and conduct or the RFP proposal process.
May assist with DSMB/DMC coordination and management.
Perform other duties as assigned and comply with all policies and standards.