Senior Clinical Trial Associate (CONTRACT)

Entrada TherapeuticsBoston, MA
Remote

About The Position

Entrada Therapeutics is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. Through proprietary and versatile approaches, Entrada is advancing a robust development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases, among others. Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne muscular dystrophy (DMD) who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered with Vertex Pharmaceuticals to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1 (DM1). 2026 represents a catalyst-rich period for Entrada. We expect multiple clinical data readouts as we advance several DMD programs across the U.K., EU, and U.S. By year-end 2026, we anticipate four clinical-stage programs in our DMD franchise (ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51). These programs are complemented by the ongoing clinical progress of our DM1 collaboration with Vertex (VX-670). We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families. This individual will assist the clinical operations team in the day-to-day operations, study start up and set-up, execution, and closeout of assigned trials. The individual is accountable to the clinical trial team for the support of trial execution and works collaboratively with cross-functional team members and vendors to ensure proper set-up of trial processes and plans to execute the protocol in accordance with established SOPs and standards.

Requirements

  • BA/BS degree with at least 2+ years of relevant experience in clinical operations working at a biotech or pharmaceutical company.
  • Strong understanding of clinical trial operations, including all phases from study start-up to close-out.
  • Ability to work independently and take initiative on projects under minimal supervision.
  • General working knowledge of drug development and ICH/GCP guidelines is required.
  • Excellent interpersonal, written, administrative, and computer skills.
  • Excellent verbal and written communication skills with a strong attention for detail.

Nice To Haves

  • Previous CRO or vendor management experience preferred.

Responsibilities

  • Support the day-to-day operations of assigned trials to ensure completion per established project team goals and objectives in compliance with ICH/GCP guidelines, from study start-up to close-out.
  • Provides accurate and up- to-date clinical trial information within relevant tracking tools and provides regular updates of trial progression to the clinical trial team, including those related to protocol deviations, adverse events, and site personnel trainings.
  • Contribute to the development of trial related plans and manuals.
  • Ensures timely maintenance of the TMF, filing and reconciliation according to regulatory guidance and internal SOPs.
  • Participates and ensures appropriate documentation of clinical team meetings, including meeting minutes, agendas, and action items.
  • Manage vendor POs and trial payments (including budget reconciliation), including invoice review and approval.
  • Support the set-up and management of clinical trial supplies and biosample management where needed (drug product, ancillary and other).
  • Assist in external training activities (suppliers, clinical sites etc.).
  • Assist in the management of trial completion activities, including data review, database lock and trial closeout.
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