Senior Clinical Operations Contractor

The Perfect Addition to Our Team

You are excited about the opportunity to spearhead clinical trial activities and support the continued growth of our clinical operations function here at Entrada. You are well organized and like to share best practices in clinical operations. You enjoy a fast-paced environment and juggling competing priorities and are willing to jump in and help wherever it is needed. You follow up and follow through, efficiently connecting problems with solutions. You work successfully in a team environment and have strong interpersonal skills, in order to effectively build working relationships inside and outside of the company.

The Opportunity

This individual will lead in the day-to-day operations, planning, set-up, execution, and closeout of assigned clinical trials. They will 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.

Responsibilities

• Lead and/or support 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 etc.
• Proactively identify and support resolution/escalation of trial conduct-related issues.
• Manage and lead 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.
• Oversee 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.

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 combined experience supporting and independently managing clinical trial activities.
• Strong knowledge of ICH/GCP and regulatory requirements, with a strong preference for experience with 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.
• This is a long-term contract position with an expected 30-40 hours per week. It is a US based remote position, with preference given to local New England based candidates. This role will require minimum monthly or quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA. #LI-Remote #LI-JF1