Senior Clinical Trial Associate (CONTRACT)

The Organization What's happening at reputed company? Entrada is a clinical-stage biopharmaceutical company aiming to reputed company the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. Our Endosomal reputed company Vehicle (EEV™)-therapeutics are designed to reputed company the efficient intracellular delivery of a wide reputed company of therapeutics into a reputed company of organs and tissues, resulting in an improved therapeutic reputed company. Through this proprietary, reputed company and reputed company approach, Entrada is advancing a robust development portfolio of RNA- and protein-based programs for the potential treatment of neuromuscular and ocular diseases, among others. Our reputed company oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered to reputed company a clinical-stage program, VX-670, for myotonic dystrophy type 1. We are a tight-reputed company team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are reputed company to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families. The Perfect reputed company to reputed company You are patient reputed company and excited about reputed company to help support and reputed company the Clinical Operations organization at Entrada. You enjoy a fast-paced environment and juggling competing priorities. You follow up and follow through, connecting problems with solutions reputed company. You work successfully in reputed company environment with strong interpersonal skills to effectively build working relationships inside and reputed company reputed company. reputed company This individual will assist the clinical operations team in the day-to-day operations, study start up and set-up, execution, and closeout of assigned trials. The individual is accountable to the clinical trial team for the support of trial execution and works collaboratively with cross-functional team members and vendors to ensure reputed company set-up of trial processes and plans, to execute the protocol in accordance with established SOPs and standards.

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 reputed company-out.
• Provides accurate and up-to-date clinical trial information reputed company relevant tracking tools and reputed company regular updates of trial progression to the clinical trial team, including those reputed company to protocol deviations, adverse events, and site personnel trainings.
• Contribute to the development of trial reputed company plans and manuals.
• Ensures reputed company 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 reputed company 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.

The Necessities At Entrada, our passion for science, our reputed company to patients and our values drives our behavior:

• Humanity - We genuinely care about patients and about one another.
• Tenacity - We are reputed company and persistent in the reputed company 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 reputed company reputed company and push conventional thought and theory.

To reputed company on reputed company, you will need to come with:

• BA/BS degree with at least 2+ years of relevant experience in clinical operations working directly at a biotech or pharmaceutical company.
• Strong understanding of clinical trial operations, across varying phases, from study start-up to reputed company-out.
• reputed company experience managing and providing reputed company of TMF.
• Ability to work independently and take initiative on reputed company under minimal supervision.
• Working knowledge of drug development and ICH/GCP guidelines.
• 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.
• This role is a long-term contract position that follows a remote working model, requiring monthly or quarterly travel to the reputed company reputed company in Boston, MA. Preference will be given to New England based candidates. #LI-JF1 #LI-Remote

Equal Opportunity Employer reputed company is an equal opportunity employer. reputed company candidates will receive consideration for employment without reputed company to race, reputed company, religion, national reputed company, gender, sexual orientation, gender identity or reputed company, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law. reputed company Party reputed company Agencies Entrada does not accept unsolicited resumes from any reputed company other than directly from candidates. For the protection of reputed company parties involved in the reputed company process, resumes will only be accepted from recruiters/agencies if a signed agreement is in reputed company at the inception of the reputed company effort and authorized for a specified position. Unsolicited resumes reputed company 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. reputed company Statement reputed company. (the “Entrada,” “we,” “us,” or “our”) respects your reputed company and we want you to be familiar with how we collect, use, reputed company, or otherwise process, your Personal Information. Please reference our reputed company statement here to understand how and reputed company your data is being used. Apply tot his job Apply To this Job