Part Time Study Manager (CONTRACT)

Entrada Therapeutics•Boston, MA

3d•Remote

About The Position

Entrada Therapeutics is a clinical-stage biopharmaceutical company focused on developing a new class of medicines for intracellular targets. They are advancing a portfolio of genetic medicines for neuromuscular and inherited retinal diseases, with key programs in Duchenne muscular dystrophy (DMD) and a collaboration with Vertex Pharmaceuticals for myotonic dystrophy type 1 (DM1). Entrada is experiencing a period of growth and is seeking colleagues who are dedicated to improving patient lives. This specific role is for an experienced part-time Contract Study Manager to support unblinded clinical trial operations. The ideal candidate will be able to independently manage unblinded workflows, maintain separation from blinded teams, and ensure operational excellence in a fast-paced environment. The contractor will be responsible for day-to-day unblinded activities, including vendor coordination, drug supply, unblinded data review, and operational documentation, requiring strong judgment, attention to detail, and comfort with sensitive information.

Requirements

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.
Ability to travel occasionally for key meetings or site visits, as needed.

Nice To Haves

Experience with EU-CTR is a plus.
Preference for candidates based in the New England region.

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).