Senior Clinical Trial Manager (CTM)

SeniorClinicalTrialManager(CTM)

Location: This position may be performed remotely with travel to the Boston area as needed.

Position Summary

Thisrolewillberesponsibleforprojectmanagementintheinitiation,executionandcloseoutofdomesticand international clinical studies, including study concept and design, feasibility assessments, study start-up, contract and budget oversight, data exchange and support of data analysis and interpretation.

This position requires both the knowledge and experience to work within established clinical trial paradigms while exploring and embracingnew approachesto conducting research to support data aggregation and analysistoadvancepatientcare.TheSr.CTMwillparticipateonclinicalprojectteamstoachievequalityresults in a cost-effective andtimelymanner.S/hewill be a key team member toestablishkey practices and procedures for the clinical team.

PrimaryResponsibilities

• Managestudyactivitiesinthesuccessfulexecutionofclinicaltrialsfromprotocolconcepttoclinical study report,complying withGood Clinical Practice (GCP) guidelines and international regulations
• Managestrategicengagementwithkeycollaborators
• Set-upandoverseeclinicaltrial-relatedtrackerssuchasregulatorydocuments,trialmasterfile(TMF), startup progress, screening/enrollment, study invoices/payments, project budgets, etc.
• KeycontributortoIRB/ECandregulatorysubmissions
• OverseeTMFreviewstoensurecompletenessandinspectionreadiness
• RegularlyreviewdocumentstoensureadherencetoClinicalOperationsand/orprojectspecificquality requirements (e.g.SOPs, work practices, training guides)
• Identifyandmitigateagainststudyrisks,escalatingasnecessary
• Directinitiativestoidentifyandimplementbestpracticesandcontinuousimprovementplansin clinical development

EducationandProfessionalExperience

• Bachelor’sdegreeinascientificfieldrequired;advancedscientificdegreeaplus
• 5+yearsdirectlymanagingclinicaltrialsinSponsororCROsetting
• In-depthknowledgeofclinicaltrialoperations,ICH,GCPGuidelinesandotherapplicableregulatoryrequirements
• Experiencedirectingmembersofclinicaloperationsteams
• Experienceworkinginateamacrossmultiplefunctionalareas(e.g.,QualityAssurance,Data Management, Biostats, Medical Writing, Safety, Clinical Supply, Finance)

OtherEssentialsandKeySuccessFactors

• Intellectualcuriosity,innovationandcreativeproblemsolvingwithanentrepreneurialspirit
• Abilitytothinkcriticallyinfast-pacedprojectswithakeensenseofurgencyanddemonstratedability to problem solve
• Self-motivatedandabletoworkautonomously,aswellasamemberofacollaborativeteam
• Highly-organizedanddetail-orientedwithapassiontodeliverqualityresults
• Strongverbalandwrittencommunicationskillswithanabilitytobuildrelationshipsinternallyandexternally
• Highestlevelsofprofessionalism,confidence,personalvaluesandethicalstandards

Annualized Base Salary

$168,000—$188,000 USD

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage.Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long‑term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together!

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust , Ownership , Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

Diversity, Equity & Inclusion

Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.