Remote Study Start-Up Lead

Entrada Therapeutics; Boston (MA); On-site; USD 60,000 - 90,000; Part time

Job summary

Entrada Therapeutics is seeking a part-time, remote Senior Clinical Operations professional to lead and assist with start-up activities for ongoing and new clinical studies. The role focuses on study start up, CRO oversight, site activation, and regulatory submissions, while ensuring alignment with ICH/GCP and company policies.

The ideal candidate has 8+ years in global clinical trial support, exceptional communication skills, and the ability to manage multiple priorities in a fast-paced

Qualifications

• BA/BS degree with 8+ years of experience supporting and independently managing clinical trial activities globally.
• Strong knowledge of ICH/GCP and regulatory requirements.
• Strong experience in drug development, including trial design, planning and management, and CRO/vendor oversight.
• Excellent verbal and written communication skills.
• Proven ability to work effectively across functions.
• Ability to travel ~10% of the time.

Responsibilities

• Lead and/or support Sr. CTMs/CTMs with start up and maintenance activities, including regulatory submissions, country and site selection, site budget management, site activation, ICF review, etc.
• Collaborate on developing study-specific start up plans and protocol amendments.
• Drive start-up activities including site selection/activation, EC submissions and query responses, document collection, and protocol amendments.
• Review country-level ICFs and related materials for approval by required functions.
• Review and approve site activation packages and regulatory documentation, tracking information in databases.
• Identify and resolve start up or trial execution issues.
• Coordinate with cross-functional teams and external vendors on study start up.
• Develop and implement study-specific training and kick-off meetings for study personnel.

Skills

Clinical trial start up

Regulatory submissions

Site activation

CRO/vendor oversight

Cross-functional collaboration

Verbal and written communication

Travel readiness

Education

BA/BS degree

Job description

Entrada Therapeutics is seeking a part-time, remote Senior Clinical Operations professional to lead and assist with start-up activities for ongoing and new clinical studies. The role focuses on study start up, CRO oversight, site activation, and regulatory submissions, while ensuring alignment with ICH/GCP and company policies.

The ideal candidate has 8+ years in global clinical trial support, exceptional communication skills, and the ability to manage multiple priorities in a fast-paced