Clinical Trial Manager I

Emmes Group•Rockville, MD

4h•Remote

About The Position

The Clinical Trial Manager (CTM) I leads regional operational activities for one or more clinical studies, tracks clinical site progress and quality, and oversees the monitoring team and its deliverables, including the clinical monitoring plan and site visit reports. The CTM I helps ensure study timelines are met and communicates progress to the Project Leader/Global Clinical Project Manager. The role also oversees site management and monitoring activities. The CTM I coordinates study implementation and clinical operations across the study lifecycle, in accordance with applicable corporate and project procedures, study plans, and sponsor requirements. The role supports study planning, site activation and closeout, monitoring, safety reporting, data collection, site supplies and investigational product accountability, and study documentation. It also involves working with clients, vendors, CRAs, internal collaborators, and safety and data teams to maintain study quality, compliance, and progress.

Requirements

Bachelor's degree in a science-related field.
4–6 years of relevant clinical research experience (the posting also specifies 5 years).
1–3 years of experience as a CRA or in a clinical operations coordinating role.
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 Microsoft Office Suite.
Strong computer and organizational skills, with high attention to detail.
Ability to work across varying projects and exercise 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 skills, 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.

Responsibilities

Maintain detailed knowledge of the study protocol, 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 the study lifecycle in accordance with procedures, 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 updates to internal and external collaborators.
Under the guidance of the Project Leader/Global Clinical Project Manager, potentially 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 Manual of Procedures, Clinical Monitoring Plan, 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 master informed consent forms, participant-facing documents, site training materials, visit-specific annotated reports, monitoring visit checklists, and monitoring correspondence.
Ensure study site documents remain current and ethics approvals are maintained, as applicable.
Ensure CRA staff meet study timelines and deliverables, including monitoring plans, risk-based or targeted monitoring 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 process improvements to support regulatory compliance.
Maintain metrics related to site assessment, feasibility and selection, site activation, and closeout.
Track site performance and quality; monitor study progress 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 guidance, report development, data collection requirements, and eCRF design.
Communicate frequently with the safety medical monitor to ensure safety reporting information is included in key study documents and reporting is performed as required; track reporting and follow-up of adverse events, serious adverse events, and suspected unexpected adverse events.
Manage study-level supplies and investigational product/device accountability, including vendor coordination as applicable.
Track study document filing and archiving.
Conduct observational, training, and co-monitoring visits with CRAs as applicable.
Assist with bid defense preparation and conduct or the RFP proposal process as needed.
Assist with DSMB/DMC coordination and management as needed.
Perform other duties as assigned and comply with company policies and standards.