Senior Clinical Operations Contractor

About the role

Entrada Therapeutics is a clinical‑stage biopharmaceutical company developing intracellular‑targeted genetic medicines for neuromuscular and inherited retinal diseases, with lead oligonucleotide programs for Duchenne muscular dystrophy exons 44, 45, 50 and 51 and a Vertex partnership program VX‑670 for myotonic dystrophy type 1. The company anticipates multiple clinical data readouts by end‑2026 and four DMD clinical‑stage programs (ENTR‑601‑44, ‑45, ‑50, ‑51) plus ongoing DM1 collaboration. The team is tight‑knit, high‑energy, and dedicated to improving patients’ lives.

You will spearhead clinical trial activities and support the growth of the clinical operations function. You are well organized, enjoy sharing best practices, thrive in a fast‑paced environment, juggle competing priorities, follow up and follow through, and work successfully in a team with strong interpersonal skills.

Responsibilities

• Lead and/or support study activities, including vendor evaluation and selection, country and site selection, informed consent development and maintenance, eCRF design and implementation, protocols, study plans and manuals, IBs, CSRs, etc.
• Proactively identify and support resolution/escalation of trial conduct‑related issues.
• Manage and lead cross‑functional trial teams, collaborating with internal team members and external vendors for planning and execution of clinical trials through closeout.
• Provide regular up‑to‑date trial information and updates on trial progress/performance to internal stakeholders (enrollment, eligibility, protocol deviations, AE reporting, etc.).
• Oversee clinical monitoring from site qualification to site closure visits to assure integrity of clinical data with respect to accuracy, accountability and documentation through review of case report forms, source documents, and medical records.
• Oversee the review/cleaning and reconciliation of all clinical data, including EDC, PROs, and third‑party labs to support timely database lock and accurate analysis of clinical data.

Requirements

• BA/BS degree with 7+ years of combined experience supporting and independently managing clinical trial activities.
• Strong knowledge of ICH/GCP and regulatory requirements, with a preference for experience with EU‑CTR.
• Strong experience in the drug development process, including trial design, trial planning and management, and CRO and vendor oversight.
• Excellent verbal and written communication skills.
• Proven ability to work effectively across functions.
• Long‑term contract position with an expected 30‑40 hours per week.
• US‑based remote role; preference given to local New England‑based candidates.
• Requires minimum monthly or quarterly travel to Entrada Therapeutics Headquarters in Boston, MA.