Study Start Up Lead Contractor

Entrada Therapeutics • Boston, MA

2d • Remote

About The Position

This individual will partner with study leads on varying operational initiatives across on-going and new clinical studies for study start up and enrollment. This role will support the overall planning and management of clinical trials, 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.

Requirements

• 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.

Nice To Haves

• Preference given to local New England based candidates.

Responsibilities

• 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)

What This Job Offers

• Job Type: Part-time
• Career Level: Mid Level