Part Time Study Manager (CONTRACT)
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AI Summary
The Organization
What's happening at Entrada Therapeutics? 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 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.
The Opportunity
We are seeking an experienced part‑time Contract Study Manager to support unblinded clinical trial operations across one or more ongoing studies. This role is ideal for a seasoned clinical operations professional who can independently manage unblinded workflows, maintain strict separation from blinded teams, and ensure operational excellence in a fast‑moving environment.
The contractor will oversee day‑to‑day unblinded activities, including vendor coordination, drug supply workflows, unblinded data review, and operational documentation. This role requires exceptional judgment, attention to detail, and comfort working with sensitive information.
Responsibilities
- Serve as the unblinded operational lead for assigned clinical studies, ensuring all activities are conducted in compliance with ICH/GCP, regulatory requirements, and internal procedures.
- Support and manage various study activities, including CROs, country and site selection, informed consent development and maintenance, eCRF design and implementation, protocols, study plans and manuals, IBs, CSRs
- Oversee study documentation, including study plans, logs, trackers, and training materials.
- Support data review, reconciliation, and issue resolution in collaboration with Data Management, Biostatistics, and Safety teams.
- Maintain appropriate firewalls between blinded and unblinded personnel, ensuring study integrity.
- Provide unblinded operational updates to internal stakeholders while safeguarding treatment‑related information.
- Proactively identify and support resolution/escalation of trial conduct-related issues.
- Participate in cross‑functional meetings as the unblinded representative, escalating risks and proposing mitigation strategies.
- Support components of site start‑up, ongoing monitoring, and closeout activities.
- Contribute to inspection readiness and support regulatory or QA requests related to unblinded processes.
- Provide flexible support aligned with study needs, including availability during key milestones (e.g., dose escalations, interim analyses, database locks).
The Necessities
At Entrada, our passion for science, our devotion to patients and our values drives our behavior:
- 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.
To thrive on our team, you will need to come with:
- BA/BS degree with 7+ years of clinical operations experience, including direct involvement in unblinded or partially blinded study management.
- Strong working knowledge of ICH/GCP, clinical trial conduct, and regulatory expectations within global clinical trials.
- Strong experience in the drug development process, including trial design, trial planning and management, and CRO and vendor oversight.
- Excellent communication skills and proven ability to work effectively across functions.
- Highly organized, detail‑oriented, and able to work independently in a contract capacity.
- Experience with EU‑CTR is a plus.
- Ability to travel occasionally for key meetings or site visits, as needed.
- Preference for candidates based in the New England region.
- This is a part-time contract, US based remote position, with preference given to local New England based candidates. #LI-JF1 #LI-Remote
Equal Opportunity Employer
Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law.
Third Party Staffing Agencies
Entrada does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Entrada from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Entrada and do not obligate Entrada to pay fees if we hire from those resumes.
Privacy Statement
Entrada Therapeutics, Inc. (the “Entrada,” “we,” “us,” or “our”) respects your privacy and we want you to be familiar with how we collect, use, share, or otherwise process, your Personal Information. Please reference our privacy statement here to understand how and when your data is being used.
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