Senior Clinical Trial Manager Position Available In Suffolk, Massachusetts
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Job Description
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 oversee theplanning and management of the operational aspects, including CROand vendor oversight, to achieve project milestones and clinicalstudy timelines in alignment with company goals and in compliancewith local, ICH, GCP, and company policies and procedures.
Responsibilities Ownership of all operational aspects of clinicaltrials, including CRO and vendor management. Lead and/or supportstudy activities, including vendor evaluation and selection,country and site selection, informed consent development andmaintenance, eCRF design and implementation, protocols, study plansand manuals, IBs, CSRs etc. Proactively identify and supportresolution/escalation of trial conduct-related issues. Manage andlead cross-functional trial teams, including collaborating withinternal team members and external vendors for the planning andexecution of clinical trials, through closeout. Provide regularup-to-date trial information and regular updates on trialprogress/performance to internal stakeholders (enrollment,eligibility, protocol deviations, AE reporting etc.). Overseeclinical monitoring from site qualification to site closure visitsto assure integrity of clinical data with respect to accuracy,accountability and documentation through review of case reportforms, source documents, and medical records. Oversee thereview/cleaning and reconciliation of all clinical data, includingEDC, PROs, and 3rd party labs to support timely database lock andthe accurate analysis of clinical data. Partner with relevantstakeholders to develop and implement appropriate study-specifictraining to all relevant study-related personnel (internal, CRO,Site staff, and other relevant 3rd parties). Support development ofdepartment documentation, such as SOPs. Help develop, organize, andmaintain study budgets, working with business operations to ensureaccurate forecasting. Support monitoring activities and visitclinical study sites as needed. The Necessities At Entrada, ourpassion for science, our devotion to patients and our values drivesour behavior: Humanity
- We genuinely care about patients and aboutone another. Tenacity
- We are relentless and persistent in thepursuit of developing therapies for patients. Creativity
- We arecreative problem solvers. Collaboration
- We are more than the sumof our parts. Curiosity
- We have a growth mindset and pushconventional thought and theory.
To thrive on our team, you willneed to come with: BA/BS degree with 8 years of combined experiencesupporting and independently managing clinical trial activities.
Strong knowledge of ICH/GCP and regulatory requirements, with astrong preference for experience with EU-CTR. Strong experience inthe drug development process, including trial design, trialplanning and management, and CRO and vendor oversight. Excellentverbal and written communication skills. Proven ability to workeffectively across functions. Ability to travel approximately 20%of the time, as determined by the needs of the business. This is aUS based remote position, with preference given to local NewEngland based candidates. This role will require minimum monthly orquarterly travel to the Entrada Therapeutics Headquarters locatedin Boston, MA. LI-JF1 LI-Remote The Perks By becoming a team memberhere at Entrada, you’ll have access to competitive health, dental,and vision 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.