Study Start Up Lead Contractor

About the Organization

Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets previously 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 Duchenne muscular dystrophy (DMD) patients amenable to exon 44, 45, 50, and 51 skipping. Entrada has partnered with Vertex Pharmaceuticals to develop VX-670, a clinical-stage program for myotonic dystrophy type 1 (DM1).

2026 represents a catalyst-rich period, with multiple clinical data readouts expected 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), complemented by ongoing clinical progress of our DM1 collaboration with Vertex (VX-670).

We are a tight-knit team of experts and leaders in therapeutic development and rare diseases, dedicated to dramatically improving the lives of patients and their families.

About the Role

This individual will partner with study leads on operational initiatives across ongoing and new clinical studies for study start-up and enrollment. The role supports the overall planning and management of clinical trials, including CRO and vendor oversight, to achieve project milestones and clinical study timelines in alignment with company goals and in compliance with local, ICH, GCP, and company policies and procedures.

Responsibilities

• Lead and/or support Sr. CTMs/CTMs with study start-up and maintenance activities, including regulatory submissions, country and site selection, site budget management, site activation, ICF review, etc.
• Collaborate with Sr. CTM/CTMs on developing study-specific strategic start-up or protocol amendment implementation plans.
• Drive start-up activities including timely site selection and activation, EC submissions and query responses, document collection, and protocol amendment activities.
• Review country-level ICFs and related site or patient-facing materials and route for approval by required functional areas.
• Review and approve site activation packages and regulatory documentation, ensuring complete and accurate information tracked in the appropriate databases.
• Proactively identify and support resolution/escalation of issues impacting start-up or trial execution.
• Collaborate and communicate with the cross-functional trial team, including internal team members and external vendors on related study start-up activities.
• Ensure that all assigned start-up activities are on track and support study deliverables.
• Partner with relevant stakeholders to develop and implement appropriate study-specific training and kick-off meetings for all relevant study-related personnel (internal, CRO, site staff, and other third parties).

Requirements

• BA/BS degree with 8+ years of combined experience supporting and independently managing clinical trial activities globally.
• Strong knowledge of ICH/GCP and regulatory requirements.
• 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.
• Ability to travel approximately 10% of the time, as determined by business needs.

Company Values

• Humanity: We genuinely care about patients and about one another.
• Tenacity: We are relentless and persistent in the pursuit of developing therapies for patients.
• Creativity: We are creative problem solvers.
• Collaboration: We are more than the sum of our parts.
• Curiosity: We have a growth mindset and push conventional thought and theory.

Schedule

This is a part-time, long-term contract position estimated to be ~20-30 hours per week.

Location

This is a US-based remote position, with preference given to local New England-based candidates. The role may require ad-hoc travel to the Entrada Therapeutics Headquarters located in Boston, MA.