Senior Clinical Trial Associate (CONTRACT)

About the role

You are patient focused and excited about the opportunity to help support and develop the Clinical Operations organization at Entrada. You enjoy a fast-paced environment and juggle competing priorities. You follow up and follow through, connecting problems with solutions efficiently. You work successfully in a team environment with strong interpersonal skills to effectively build working relationships inside and outside the company.

Responsibilities

• Support the day-to-day operations of assigned trials to ensure completion per established project team goals and objectives in compliance with ICH/GCP guidelines, from study start-up to close-out.
• Provides accurate and up-to-date clinical trial information within relevant tracking tools and provides regular updates of trial progression to the clinical trial team, including those related to protocol deviations, adverse events, and site personnel trainings.
• Contribute to the development of trial related plans and manuals.
• Ensures timely maintenance of the TMF, filing and reconciliation according to regulatory guidance and internal SOPs.
• Participates and ensures appropriate documentation of clinical team meetings, including meeting minutes, agendas, and action items.
• Manage vendor POs and trial payments (including budget reconciliation), including invoice review and approval.
• Assist in external training activities (suppliers, clinical sites etc.).
• Assist in the management of trial completion activities, including data review, database lock and trial closeout.

Requirements

• BA/BS degree with at least 2+ years of relevant experience in clinical operations working at a biotech or pharmaceutical company.
• Strong understanding of clinical trial operations, including all phases from study start-up to close-out.
• Ability to work independently and take initiative on projects under minimal supervision.
• General working knowledge of drug development and ICH/GCP guidelines is required.
• Previous CRO or vendor management experience preferred.
• Excellent interpersonal, written, administrative, and computer skills.
• Excellent verbal and written communication skills with a strong attention for detail.
• Ability to travel approximately 5% of the time, as determined by the needs of the business.

Qualifications

• This role is a long-term contract position that follows a remote working model, requiring monthly or quarterly travel to the Entrada Therapeutics Headquarters in Boston, MA.

Skills

• Strong organizational and time management skills.
• Excellent communication and interpersonal skills.
• Proficiency in Microsoft Office Suite.
• Experience with clinical trial software systems (e.g., eCOA, eTMF).

Benefits

Equal Opportunity Employer. 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.

Pay

Commensurate with experience.

Schedule

Remote working model, requiring monthly or quarterly travel to the Entrada Therapeutics Headquarters in Boston, MA.