Remote Clinical Trial Start-Up Lead

Entrada-Therapeutics; Boston (MA); On-site; USD 83,000 - 117,000; Part time

Job summary

Entrada Therapeutics in the US is seeking a part-time clinical operations professional to spearhead study start up and enrollment activities for multiple trials. The role partners with study leads to coordinate start up, regulatory submissions, site activation, and vendor oversight to meet milestones while complying with ICH/GCP guidelines.

You will manage country-level ICF reviews, activate sites, and ensure traceable documentation.

Qualifications

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

Responsibilities

• Lead and support Sr. 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)

Skills

Clinical trial management

ICH/GCP knowledge

Drug development process

Communication skills

Education

BA/BS degree

Job description

Entrada Therapeutics in the US is seeking a part-time clinical operations professional to spearhead study start up and enrollment activities for multiple trials. The role partners with study leads to coordinate start up, regulatory submissions, site activation, and vendor oversight to meet milestones while complying with ICH/GCP guidelines.

You will manage country-level ICF reviews, activate sites, and ensure traceable documentation.