Study Start Up Lead Contractor

• Lead and/or support Sr. CTMs/CTMs with study start up and maintenance activities, including regulatory submissions, country and site selection, site budget management, site activation, ICF review, etc.
• Collaborate with Sr. CTM/CTMs on developing study specific strategic start up or protocol amendment implementation plans.
• Drive start-up activities including timely site selection and activation, EC submissions and query responses, document collection, and protocol amendment activities.
• Reviewing country-level ICFs and related site or patient facing materials and routing for approval by required functional areas.
• Review and approve site activation packages and regulatory documentation, ensuring complete and accurate information tracked in the appropriate databases.
• Proactively identify and support resolution/escalation of issues impacting start up or trial execution.
• Collaborate and communicate with the cross-functional trial team, including collaborating with internal team members and external vendors on related study start up activities.
• Ensure that all assigned start up activities are on track and support study deliverables.
• Partner with relevant stakeholders to develop and implement appropriate study-specific training and kick-off meetings to all relevant study-related personnel (internal, CRO, Site staff, and other relevant 3rd parties)

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 8 + years of combined experience supporting and independently managing clinical trial activities globally.
• Strong knowledge of ICH/GCP and regulatory requirements.
• 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 10% of the time, as determined by the needs of the business.

This is a part-time, long-term contract position estimated to be ~20-30 hours per week.

The role is a US based remote position, with preference given to local New England based candidates.

This role may require ad-hoc travel to the Entrada Therapeutics Headquarters located in Boston, MA. #LI-JF1 #LI-Remote

Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law.

Entrada does not accept unsolicited resumes from any source other than directly from candidates.

For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position.

Unsolicited resumes sent to Entrada from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Entrada and do not obligate Entrada to pay fees if we hire from those resumes.

Entrada Therapeutics, Inc. (the “ Entrada ,” “ we, ” “ us, ” or “ our ”) respects your privacy and we want you to be familiar with how we collect, use, share, or otherwise process, your Personal Information.

Please reference our privacy statement here to understand how and when your data is being used.