Entrada Therapeutics
Location
Boston, Massachusetts
Support day-to-day operations of assigned clinical trials from start-up to close-out in compliance with ICH/GCP guidelines. Manage trial documentation, vendor payments, and clinical trial supplies while providing regular progress updates to the team.
Requires a BA/BS degree and at least 2 years of relevant clinical operations experience within a biotech or pharmaceutical company. Must have a strong understanding of drug development and the ability to work independently with minimal supervision.
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. Support the set-up and management of clinical trial supplies and biosample management where needed (drug product, ancillary and other). 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. The Necessities 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 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. #LI-Remote #LI-JF1 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. 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. Third Party Staffing Agencies 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. Privacy Statement 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.
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