The Opportunity

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.
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.

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 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
• This 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.

What We Offer: Meaningful Work, Fair Rewards, and Real Support

At Entrada Therapeutics, we understand that compensation and total rewards are a major consideration when exploring a new opportunity. We believe in transparency and equity and are committed to sharing salary ranges for every position, along with insight into our compensation philosophy, in accordance with certain state requirements in the United States and fostering a fair and open environment at the onset.

But we also know it is more than just pay. When you join Entrada, you'll be part of a mission-driven team with access to comprehensive health, dental and vision coverage; life and disability insurance; with a 401(k) match. We pride ourselves on offering competitive benefits that empower our employees and reflect the value of their contributions - offering paid, gender-inclusive parental leave, holistic support for your health and well-being, education reimbursement, discretionary time off and commuting benefits aligned to your working model. If you find yourself working from our office in Boston's Seaport District, this puts you steps away from some of the best the city has to offer.

"Our approach to compensation is grounded in transparency, equity and performance for the unique contributions each person brings. At Entrada, we know that meaningful work deserves meaningful reward - and we view compensation as one way we show appreciation for the collaboration, curiosity and commitment that drive our mission forward."

- Kerry Robert, SVP of People

The salary for this opportunity ranges from $160,000 - $185,000. The final base compensation offered will depend on several considerations which include but may not be limited to a candidate's skills, competencies, experience and other job-related factors permitted by law. The final salary offered may fall outside of this range. #LI-JF1 #LI-Remote