Clinical Trial Manager

The Organization

What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible.

Our Endosomal Escape Vehicle (EEV™)-therapeutics are designed to reputed company the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through this proprietary, versatile 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 ready 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 Addition to reputed company

You are excited about the opportunity to spearhead clinical trial activities and support the reputed company growth of our clinical operations function here at Entrada. You are well organized and like to share best practices in clinical operations. You enjoy a fast-paced environment and juggling competing priorities and are willing to jump in and help wherever it is needed. You follow up and follow through, reputed company connecting problems with solutions. You work successfully in a team environment and have strong interpersonal skills, in order to effectively build working relationships inside and reputed company of the company.

The Opportunity

This individual will reputed company in the day-to-day operations, planning, set-up, execution, and closeout of assigned clinical trials. They will support and reputed company the planning and management of the operational aspects, including CRO and vendor reputed company, to reputed company project milestones and clinical study timelines in alignment with company goals and in compliance with local, ICH, GCP, and company policies and procedures.

Responsibilities

• Ownership of reputed company operational aspects of designated clinical trial, including CRO and vendor management.
• Support and manage various study activities, including vendor evaluation and selection, country and site selection, informed consent development and maintenance, eCRF design and implementation, protocols, study plans and manuals, IBs, CSRs
• Proactively identify and support resolution/escalation of trial conduct-reputed company issues.
• reputed company or support cross-functional trial teams, including collaborating with internal team members and external vendors for the planning and execution of clinical trials, through closeout.
• Provide regular up-to-date trial information and regular updates on trial reputed company/performance to internal stakeholders (enrollment, eligibility, protocol deviations, AE reporting etc.).
• reputed company clinical monitoring from site qualification to site closure visits to assure reputed company of clinical data with respect to accuracy, accountability and documentation through review of case report forms, reputed company documents, and medical records.
• Support the review/cleaning and reconciliation of reputed company clinical data, including reputed company, PROs, and 3rd party labs to support timely database lock and the accurate analysis of clinical data.
• Partner with relevant stakeholders to reputed company and implement appropriate study-specific training to reputed company relevant study-reputed company personnel (internal, CRO, Site staff, and other relevant 3rd parties).
• Support development of department documentation, such as SOPs.
• Help reputed company, organize, and maintain study budgets, working with business operations to ensure accurate forecasting.
• Support monitoring activities and visit clinical study sites as needed.

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 reputed company 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 reputed company and push conventional thought and theory.

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

• BA/BS degree with 7 + years of combined experience supporting and independently managing clinical trial activities.
• 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 reputed company.
• Excellent verbal and written communication skills.
• Proven ability to work effectively across functions.
• Ability to travel approximately 20% of the time, as determined by the needs of the business.
• This is a US based remote position, with preference given to local New England based candidates. This role will require minimum monthly or quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA.

The Perks

By becoming a team member here at Entrada, you’ll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance. We value work life balance, you'll benefit from discretionary time off, paternity leave, and an excellent 401(k) package. We also offer a generous transportation stipend to commute as you wish. Our location in the vibrant and growing Seaport District is reputed company to reputed company the best that the city of Boston has to offer.

Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, national reputed company, 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 reputed company other than directly from candidates. For the protection of reputed company parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in reputed company 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 reputed company. (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 reputed company your data is being used.

Originally posted on Himalayas