Senior Clinical Trial Associate (CONTRACT)

About Entrada Therapeutics

Entrada Therapeutics is a clinical-stage biopharmaceutical company dedicated to creating a new class of medicines for patients with challenging intracellular targets. Leveraging proprietary approaches, Entrada is developing genetic medicines for neuromuscular and inherited retinal diseases. Their lead oligonucleotide programs are focused on Duchenne muscular dystrophy (DMD), and they have a collaboration with Vertex Pharmaceuticals for a clinical-stage program, VX-670, for myotonic dystrophy type 1 (DM1).

2026 is a significant year for Entrada, with anticipated clinical data readouts for several DMD programs and the progression of their DM1 collaboration. They are a team of experts in therapeutic development and rare diseases, seeking passionate individuals to join their high-energy, results-driven team.

The Ideal Candidate

The ideal candidate is patient-focused, thrives in a fast-paced environment, and excels at managing competing priorities. You are a proactive problem-solver with strong interpersonal skills, capable of building effective relationships both internally and externally. You demonstrate strong follow-through and a commitment to connecting problems with solutions.

The Opportunity

This role supports the clinical operations team in managing the day-to-day operations of assigned clinical trials. This includes study start-up, execution, and close-out. The Senior Clinical Trial Associate collaborates with cross-functional teams and vendors to ensure trials are conducted according to protocols, SOPs, and ICH/GCP guidelines.

Responsibilities

• Support the day-to-day operations of assigned clinical trials, ensuring completion in line with project goals and ICH/GCP guidelines from study start-up to close-out.
• Maintain accurate and up-to-date clinical trial information in tracking tools, providing regular updates on trial progression, protocol deviations, adverse events, and site personnel training.
• Contribute to the development of trial-related plans and manuals.
• Ensure timely maintenance, filing, and reconciliation of the Trial Master File (TMF) according to regulatory guidance and internal SOPs.
• Document and distribute clinical team meeting minutes, agendas, and action items.
• Manage vendor purchase orders (POs) and trial payments, including invoice review and approval, and budget reconciliation.
• Support the setup and management of clinical trial supplies and biosample management as needed.
• Assist in external training activities for suppliers and clinical sites.
• Support trial completion activities, including data review, database lock, and trial closeout.

Qualifications and Values

Entrada Therapeutics values humanity, tenacity, creativity, collaboration, and curiosity. To succeed in this role, you should possess:

• BA/BS degree with at least 2 years of relevant experience in clinical operations at a biotech or pharmaceutical company.
• Strong understanding of clinical trial operations across all phases (study start-up to close-out).
• Ability to work independently and take initiative with minimal supervision.
• General working knowledge of drug development and ICH/GCP guidelines.
• Previous CRO or vendor management experience is preferred.
• Excellent interpersonal, administrative, and computer skills.
• Excellent verbal and written communication skills with strong attention to detail.
• Ability to travel approximately 5% of the time.
• This is a long-term contract position with a remote working model, requiring monthly or quarterly travel to Entrada Therapeutics Headquarters in Boston, MA.

Equal Opportunity Employer

Entrada Therapeutics is an equal opportunity employer committed to diversity and inclusion.

Third Party Staffing Agencies & Privacy Statement

Entrada does not accept unsolicited resumes and requires signed agreements with agencies. Please refer to Entrada's privacy statement for information on data handling.

Key skills/competency

• Clinical Trial Operations
• ICH/GCP Guidelines
• Biotech/Pharmaceutical Experience
• Study Start-up
• Trial Execution
• Trial Close-out
• TMF Management
• Vendor Management
• Regulatory Compliance
• Patient Focus