Clinical Trial Manager

Entrada Therapeutics•Boston, MA

7d•$136,000 - $163,000•Remote

About The Position

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. Our Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA- and protein-based programs for the potential treatment of neuromuscular and ocular diseases, among others. Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1. 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. This individual will lead the day-to-day operations, planning, set-up, execution, and closeout of assigned clinical trials. They will support and oversee the planning and management of the operational aspects, 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.

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

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 3 rd 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 3 rd 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.