Senior Clinical Trial Manager

Entrada Therapeutics•Boston, MA

6d•$160,000 - $185,000•Remote

About The Position

Entrada Therapeutics is a clinical-stage biopharmaceutical company focused on developing a new class of medicines for intracellular targets. The company is advancing a portfolio of genetic medicines for neuromuscular and inherited retinal diseases. Entrada has multiple clinical data readouts expected by 2026 for its Duchenne muscular dystrophy (DMD) programs and is collaborating with Vertex Pharmaceuticals on a program for myotonic dystrophy type 1 (DM1). Entrada is seeking colleagues who are ready to join a high-energy, dedicated team focused on improving patient lives.

Requirements

BA/BS degree with 7 + years of combined experience supporting and independently managing clinical trial activities.
Strong knowledge of ICH/GCP and regulatory requirements, with a strong preference for experience with global trials and EU-CTR.
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 20% of the time, as determined by the needs of the business

Nice To Haves

Preference given to local New England based candidates.

Responsibilities

Ownership of all operational aspects of designated clinical trial, including CRO and vendor management.
Support and manage various study activities, including vendor evaluation and selection, country and site selection, informed consent development and maintenance, eCRF design and implementation, protocols, study plans and manuals, IBs, CSRs
Proactively identify and support resolution/escalation of trial conduct-related issues.
Lead or support cross-functional trial teams, including collaborating with internal team members and external vendors for the planning and execution of clinical trials, through closeout.
Provide regular up-to-date trial information and regular updates on trial progress/performance to internal stakeholders (enrollment, eligibility, protocol deviations, AE reporting etc.).
Oversee clinical monitoring from site qualification to site closure visits to assure integrity of clinical data with respect to accuracy, accountability and documentation through review of case report forms, source documents, and medical records.
Support the review/cleaning and reconciliation of all clinical data, including EDC, PROs, and 3rd party labs to support timely database lock and the accurate analysis of clinical data.
Partner with relevant stakeholders to develop and implement appropriate study-specific training to all relevant study-related personnel (internal, CRO, Site staff, and other relevant 3rd parties).
Support development of department documentation, such as SOPs.
Help develop, organize, and maintain study budgets, working with business operations to ensure accurate forecasting.
Support monitoring activities and visit clinical study sites as needed.