Clinical Trial Manager Position Available In Suffolk, Massachusetts

Job Description:

The Organization What’s happening at Entrada Therapeutics?

Entrada is a clinical-stage biopharmaceutical company aiming totransform the lives of patients by establishing a new class ofmedicines that engage intracellular targets that have long beenconsidered inaccessible. Our Endosomal Escape Vehicle(EEV™

• therapeutics are designed to enable the efficientintracellular delivery of a wide range of therapeutics into avariety of organs and tissues, resulting in an improved therapeuticindex. Through this proprietary, versatile and modular approach,Entrada is advancing a robust development portfolio of RNA
• andprotein-based programs for the potential treatment of neuromuscularand ocular diseases, among others.

Our lead oligonucleotideprograms are in development for the potential treatment of peopleliving with Duchenne who are exon 44, 45, 50 and 51 skippingamenable. Entrada has partnered to develop a clinical-stageprogram, VX-670, for myotonic dystrophy type 1. We are a tight-knitteam of experts and leaders in both therapeutic development andrare diseases and are excited to grow and attract colleagues whoare ready to join a high-energy, dedicated team that likes to getthings done and dramatically improve the lives of patients andtheir families. The Perfect Addition to Our Team You are excitedabout the opportunity to spearhead clinical trial activities andsupport the continued growth of our clinical operations functionhere at Entrada. You are well organized and like to share bestpractices in clinical operations. You enjoy a fast-pacedenvironment and juggling competing priorities and are willing tojump in and help wherever it is needed. You follow up and followthrough, efficiently connecting problems with solutions. You worksuccessfully in a team environment and have strong interpersonalskills, in order to effectively build working relationships insideand outside of the company. The Opportunity This individual willlead in the day-to-day operations, planning, set-up, execution, andcloseout of assigned clinical trials. They will support and overseethe planning and management of the operational aspects, includingCRO and vendor oversight, to achieve project milestones andclinical study timelines in alignment with company goals and incompliance with local, ICH, GCP, and company policies andprocedures. Responsibilities Ownership of all operational aspectsof designated clinical trial, including CRO and vendor management.

Support and manage various study activities, including vendorevaluation and selection, country and site selection, informedconsent development and maintenance, eCRF design andimplementation, protocols, study plans and manuals, IBs, CSRsProactively identify and support resolution/escalation of trialconduct-related issues. Lead or support cross-functional trialteams, including collaborating with internal team members andexternal vendors for the planning and execution of clinical trials,through closeout. Provide regular up-to-date trial information andregular updates on trial progress/performance to internalstakeholders (enrollment, eligibility, protocol deviations, AEreporting etc.). Oversee clinical monitoring from sitequalification to site closure visits to assure integrity ofclinical data with respect to accuracy, accountability anddocumentation through review of case report forms, sourcedocuments, and medical records. Support the review/cleaning andreconciliation of all clinical data, including EDC, PROs, and 3 rdparty labs to support timely database lock and the accurateanalysis of clinical data. Partner with relevant stakeholders todevelop and implement appropriate study-specific training to allrelevant study-related personnel (internal, CRO, Site staff, andother relevant 3 rd parties). Support development of departmentdocumentation, such as SOPs. Help develop, organize, and maintainstudy budgets, working with business operations to ensure accurateforecasting. Support monitoring activities and visit clinical studysites as needed. The Necessities At Entrada, our passion forscience, our devotion to patients and our values drives ourbehavior: Humanity

• We genuinely care about patients and about oneanother. Tenacity
• We are relentless and persistent in the pursuitof developing therapies for patients. Creativity
• We are creativeproblem solvers. Collaboration
• We are more than the sum of ourparts. Curiosity
• We have a growth mindset and push conventionalthought and theory.

To thrive on our team, you will need to comewith: BA/BS degree with 7 years of combined experience supportingand independently managing clinical trial activities. Strongknowledge of ICH/GCP and regulatory requirements, with a strongpreference for experience with EU-CTR. Strong experience in thedrug development process, including trial design, trial planningand management, and CRO and vendor oversight. Excellent verbal andwritten communication skills. Proven ability to work effectivelyacross functions. Ability to travel approximately 20% of the time,as determined by the needs of the business. This is a US basedremote position, with preference given to local New England basedcandidates. This role will require minimum monthly or quarterlytravel to the Entrada Therapeutics Headquarters located in Boston,MA. LI-JF1 LI-Remote The Perks By becoming a team member here atEntrada, you’ll have access to competitive health, dental, andvision coverage, as well as life insurance, and short term andlong-term disability insurance. We value work life balance, you’llbenefit from discretionary time off, paternity leave, and anexcellent 401(k) package. We also offer a generous transportationstipend to commute as you wish. Our location in the vibrant andgrowing Seaport District is close to all the best that the city ofBoston has to offer. Entrada Therapeutics is an equal opportunityemployer. Qualified candidates will receive consideration foremployment without regard to race, color, religion, nationalorigin, gender, sexual orientation, gender identity or expression,age, mental or physical disability, and genetic information,marital status, citizenship status, military status, protectedveteran status or any other category protected by law. Third PartyStaffing Agencies Entrada does not accept unsolicited resumes fromany source other than directly from candidates. For the protectionof all parties involved in the recruiting process, resumes willonly be accepted from recruiters/agencies if a signed agreement isin place at the inception of the recruiting effort and authorizedfor a specified position. Unsolicited resumes sent to Entrada fromrecruiters/agencies do not constitute any type of relationshipbetween the recruiter/agency and Entrada and do not obligateEntrada to pay fees if we hire from those resumes. PrivacyStatement Entrada Therapeutics, Inc. (the ” Entrada ,” ” we, ” “us, ” or ” our “) respects your privacy and we want you to befamiliar with how we collect, use, share, or otherwise process,your Personal Information. Please reference our privacy statementhere to understand how and when your data is being used.