157 study manager jobs at 107 companies in Needham, MA
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Study Manager I (3910)
Brookline, Massachusetts, United States
$80k-$105k/yrOnsiteFull Time
DM Clinical Research: Operates an integrated network of clinical trial research sites.
5+ YOEEnsures regulatory-compliant clinical trial conduct at assigned sites, maintains study documentation, trains site staff, enforces safety reporting, and supports enrollment and data quality.
Aliso Viejo or San Clemente or Burlington or United States
$130k-$163k/yrOnsiteFull Time
GlaukosNYSE: GKOS: Develops therapies and devices for treating chronic eye diseases.
8+ YOE8+ years clinical research experience in medical device/pharma; experience leading study execution, timelines, budgets, and cross-functional teams; strong knowledge of FDA regulations and GCP; risk management skills.
Veranex: Accelerates medical technology innovation from concept to commercialization.
5+ YOEBachelor's in health sciences; 5+ years clinical study planning; FDA/ISO documentation experience; ability to manage multiple priorities; strong organizational, analytical, and communication skills.
AstraZenecaLondon Stock Exchange: AZN: Global biopharmaceutical developing and manufacturing prescription medicines.
2+ YOEBachelor's with 5+ years or MS/PhD/PharmD with 2+ years; knowledge of ICH GCP and regulatory requirements; demand planning, forecasting and analytical skills; advanced problem-solving; strong communication; flexibility in working hours.
Senior Manager, Preclinical Study Management (Cambridge, MA, US, 02142)
Cambridge, Massachusetts, United States
$145k-$196k/yrHybridFull Time
AlnylamNasdaq: ALNY: Developing and commercializing RNA interference (RNAi) therapeutics for diseases.
8+ YOEPh.D. preferred; B.S. in biology/toxicology with 8+ years industry/CRO experience; experience managing outsourced preclinical (GLP/non-GLP) studies, CRO oversight, knowledge of ICH/GLP/OECD, Smart Sheets, strong communication and organizational skills.
AstraZenecaLondon Stock Exchange: AZN: Researches and develops medicines to treat major diseases globally.
7+ YOE3+ MgmtUniversity degree in medical/biological sciences, 7+ years clinical trial experience, 3+ years global study/team leadership, ICH-GCP knowledge, project management experience, strong communication and mentoring skills.
GSKLondon Stock Exchange: GSK: Develops and manufactures innovative vaccines and specialty medicines.
Advanced degree (MD/PhD/PharmD), substantial experience designing and leading interventional clinical studies, regulatory knowledge, strong communication and organizational skills.
Senior Manager Clinical Study Lead (Clinical Experimental Sciences)
Cambridge or Armonk or Warren
$151k-$246k/yrOnsiteFull Time
RegeneronNasdaq: REGN: Discovers and manufactures medicines for serious diseases.
8+ YOEBachelor's degree and 8+ years of relevant clinical experience; experience executing clinical studies, budgeting, vendor/CRO oversight, CTMS/TMF/SharePoint familiarity, and knowledge of SOPs and ICH/GCP.
Clinical Trial Management System (CTMS), Trial Master File (TMF), Microsoft SharePoint
2+ YOEBS plus 2 years biotech experience; experience with Smartsheet, ThinkCell, sample management/shipping, LIMS (Benchling); preferred experience with in vivo studies, Microsoft Excel, and GraphPad Prism; strong organization and cross-functional communication.
Smartsheet, ThinkCell, LIMS, Benchling, Microsoft Excel, GraphPad Prism
Boston University: Private research university providing higher education degree programs.
3+ YOEBachelor's degree required (Masters preferred); 3+ years higher education experience with study abroad admissions emphasis; Microsoft Office and database/WordPress experience; strong advising, presentation, and organizational skills; occasional travel.
Associate Director, Regional Clinical Study Management
Malaysia or Basel or Beijing or Cambridge or Asia
RemoteFull Time
BeOne MedicinesNasdaq: ONC: Develops and sells innovative medicines for treating cancer worldwide.
13+ YOE3+ MgmtBachelor or higher (life science preferred), 13+ years clinical research experience, 8+ years clinical operations/project management experience, 3+ years people management; expert knowledge of ICH-GCP; fluent English; PMP preferred.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, Microsoft Teams, CTMS, EDC, eTMF
Associate Director, Clinical Operations Study Lead
Waltham, Massachusetts, United States
$159k-$195k/yrOnsiteFull Time
Dyne TherapeuticsNASDAQ: DYN: Developing therapeutics for genetically driven neuromuscular diseases.
8+ YOEUndergraduate degree in a scientific/health discipline, 8+ years clinical trial management (Phase I-III) with sponsor/CRO experience, CRO/vendor oversight, ICH/GCP knowledge, budget and TMF oversight, strong communication and leadership.
Clinical Study Delivery Lead, Global Clinical Operations, Oncology Therapy Area, R&D, Orion Corporation
Cambridge, Massachusetts, United States
$140k-$230k/yrHybridFull Time
Orion PharmaNasdaq Helsinki: ORNB: Develops, manufactures, and markets human and veterinary pharmaceuticals.
10+ YOE5+ Mgmt10+ years clinical operations experience with 5+ years leading global oncology studies; Master's preferred; experience with FIH through Ph2/3, CRO management, budgets, GCP/ICH, and inspection readiness.
Kymera TherapeuticsNASDAQ: KYMR: Develops targeted protein degradation medicines to treat human diseases.
10+ YOE10+ years in biotech/pharma with Clinical Operations project management; strong regulatory, ICH-GCP, process improvement, and cross-functional leadership.
Director, Study Quality and Compliance - Nonclinical Safety/Toxicology
Cambridge, Massachusetts, United States
$186k-$345k/yrHybridFull Time
NovartisNew York Stock Exchange: NVS: Develops and manufactures innovative prescription medicines for patients.
10+ YOEAdvanced degree in biological sciences with 10+ years (or BS with 15+ years), GLP and toxicology experience, people leadership, SEND familiarity, and software/data management experience.
Xenon PharmaceuticalsNASDAQ: XENE: Developing therapeutics for neurological and psychiatric disorders.
5+ YOEMinimum 5-8 years clinical project/study management experience; bachelor’s degree in a scientific field; strong vendor management and cross-functional collaboration.
Boston or Lexington or Austin or Nashville or Durham
$79k-$126k/yrHybridFull Time
Mass General Brigham: Provides integrated medical care, research, and clinical training services.
5+ YOEMasters required; 5+ years project management experience preferred in clinical research or multi-site trials. Experience with NIH-funded studies, federal regulations, trial operations, supervision of research staff, and monitoring enrollment/billing.
Sionna TherapeuticsNASDAQ: SION: Developing small molecule medicines to treat cystic fibrosis.
5+ YOE5+ years pharma/biotech experience including Clinical Study Lead; bachelor’s in health-related field preferred; strong clinical operations, ICH/GCP, project management, site selection/management, TMF and CRO oversight skills.