Senior Clinical Trial Manager (CTM)

Praxis Precision Medicines; United States; Hybrid; USD 168,000 - 188,000; Full time

Benefits offered by this job

Discretionary quarterly bonus

Company-paid life insurance & AD&D

401(k) with company match

Stock incentives and ESPP

Generous PTO and holidays

Job summary

Praxis Precision Medicines is seeking a Senior Clinical Trial Manager to lead domestic and international trials, from initiation through closeout. The role requires oversight of study design, start-up, budget management, TMF, and regulatory submissions, with an emphasis on cost-effective, timely delivery.

You will coordinate cross-functional teams across QA, Data Management, Biostatistics, Medical Writing and Safety, ensuring quality and regulatory compliance while driving continuous improvement

Qualifications

• Bachelor’s degree in a scientific field required; advanced degree preferred.
• 5+ years directly managing clinical trials in Sponsor or CRO setting.
• Knowledge of clinical trial operations, ICH, GCP guidelines, and regulatory requirements.
• Experienced directing members of clinical operations teams.
• Experience working in a cross-functional environment (Quality, Data Management, Biostats, Medical Writing, Safety, Clinical Supply, Finance).

Responsibilities

• Manage study activities in the successful execution of clinical trials from protocol concept to study report, ensuring GCP compliance and international regulations.
• Manage strategic engagement with key collaborators.
• Set up and oversee trial trackers (regulatory documents, TMF, startup progress, screening/enrollment, invoices/payments, budgets).
• Contribute to IRB/EC and regulatory submissions.
• Oversee TMF reviews to ensure completeness and inspection readiness.
• Review documents for adherence to SOPs, work practices, and training guides.
• Identify and mitigate study risks; escalate as necessary.
• Drive initiatives to implement best practices and continuous improvement in clinical development.

Skills

Clinical trial management

GCP guidelines

Regulatory submissions

Cross-functional collaboration

Team leadership

Education

Bachelor’s degree in a scientific field

Advanced scientific degree

Tools

TMF management

Regulatory tracking tools

Job description

Location: United States

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.

Primary Responsibilities

• 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!

Company Overview

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.