Clinical Trial Manager

NSF•Germantown, MD

15d•Hybrid

About The Position

The Clinical Trial Manager (Germantown Hybrid) serves as the primary client contact and leads all aspects of clinical study execution—from kickoff through CSR completion and regulatory submission. This role ensures seamless project delivery by driving timelines, managing resources and budgets, maintaining compliance, and fostering strong client relationships.

Requirements

Bachelor’s degree in life sciences or related field with 5+ years of clinical research experience; OR
Master’s/advanced degree with 3+ years of clinical research experience.
Strong knowledge of ICH‑GCP, FDA regulations, and clinical research operations.
Proven ability to lead cross‑functional teams and manage complex timelines.
Excellent communication, organization, and problem‑solving skills.
Proficiency in Microsoft Office and willingness to travel.

Nice To Haves

Clinical research certification (ACRP or SOCRA) preferred.

Responsibilities

Lead end‑to‑end project management across all study phases, ensuring objectives, milestones, and quality standards are met.
Oversee study conduct in alignment with FDA regulations, ICH‑GCP guidelines, and company SOPs.
Serve as a strategic communicator with clients, senior leadership, cross‑functional teams, investigators, and site staff.
Develop and manage project plans, budgets, resources, and risk‑mitigation strategies.
Evaluate and manage CROs/vendors to ensure quality, timeline, and budget expectations.
Oversee site start‑up, recruitment strategies, study documentation, and investigator meetings.
Oversee monitoring activities including review of monitoring reports for completeness, quality, and adherence to monitoring plans and SOPs.
Review CRFs, monitoring reports, data outputs, and protocol‑related materials; support resolution of data queries.
Contribute to protocol development, CRFs, ICFs, operational manuals, CSRs, and regulatory submission components.
Support IND/NDA activities and participate in regulatory interactions, bid defenses, and proposal development.
Conduct co‑monitoring or audit visits as needed and assist with continuous improvement of departmental SOPs.