Senior Clinical Trial Manager; CTM; Remote

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

This role will be responsible for project management in the initiation, execution and close out of domestic and 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 embracing new approaches to conducting research to support data aggregation and analysis to advance patient care. The Sr. CTM will participate on clinical project teams to achieve quality results in a cost-effective and timely manner. S/he will be a key team member to establish key practices and procedures for the clinical team.

• Managestudyactivitiesinthesuccessfulexecutionofclinicaltrialsfromprotocolconcepttoclinical study report,complying with
  
  Good Clinical Practice (GCP) guidelines and international regulations
• Managestrategicengagementwithkeycollaborators
• Set-upandoverseeclinicaltrial-relatedtrackerssuchasregulatorydocuments,trialmasterfile(TMF), startup progress, screening/enrollment, study invoices/payments, project budgets, etc.
• Regularlyreviewdocumentstoensureadherenceto Clinical Operations and /orprojectspecificquality requirements (e.g.SOPs, work practices, training guides)

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

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

$168,000 - $188,000 USD

At Praxis, we believe that taking care of our people (and

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.

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.