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Study Start-Up Clinical Research Associate/Specialist (Remote)
Remote Position (USA), United States

Tmf inspection readiness Financial contracts Clinical Trial Management Risk Identification Site selection Site Management ICH Clinical operations Drug Development +22

USD 114K+

Associate Principal Scientist, Sterile Drug Product Commercialization
USA - Pennsylvania - West Point, United States

Process scale up Sterile drug product Pre-approval inspection readiness Process performance qualification Product characterization Manufacturing investigations Study execution Manufacturing science Statistical Data Analysis +95

Senior Mid Full Time

USD 135K+

Senior Manager, Regulatory Affairs
Cambridge, MA, United States

Sarepta Therapeutics

Submission Preparation CMC RNA Gene editing ICH Guidelines Regulatory strategy Documentation Management Gene therapy ICH +19

Senior Full Time

USD 132K+

Sr Analyst, Statistical Programming
USA-California-Remote, United States

Edwards Lifesciences

Statistical Programming Clinical Affairs Clinical Data Management Regulatory Guidelines ICH Clinical Data ISO SAS FDA +22

Senior Mid Full Time

USD 116K+

Principal, Statistical Programming
USA-California-Remote, United States

Edwards Lifesciences

S-Plus Clinical Affairs Statistical Programming Clinical Data Management SOP Development Regulatory Guidelines ICH Clinical Data ISO +30

Senior Full Time

USD 129K+

Human Factors Engineer (HFE) / Usability Engineer (UE)
US - California - Thousand Oaks - Field/Remote, United States

Study Moderation Human Factors Engineering Usability Engineering Product validation Combination products ADAPT Design Controls User Interface Design Labeling +45

USD 104K+

Senior Study Start-Up Specialist
Remote (US), United States

Site Feasibility Site identification CTMS ICH Document management Incentive Compensation Employee stock purchase plan Financial excellence SOPS +31

Senior Mid Full Time

USD 94K+

Senior Human Factors Engineer (HFE) / Usability Engineering (UE)
US - California - Thousand Oaks - Field/Remote, United States

Usability Engineering Human Factors Engineering Medical device development Combination products ADAPT Design Controls User Interface Design Labeling Human factors +45

Senior Full Time

USD 133K+

Regulatory and Start Up Specialist
Remote, United States

Precision for Medicine

Translation Coordination IRB Submissions TMF Site start-up Budget negotiation Site visits ICH GCP ICH Guidelines ICH +29

USD 80K+

Regulatory and Start Up Specialist
Remote, United States

Precision Medicine Group

Translation Coordination IRB Submissions TMF Budget negotiation Site start-up Site visits Contracts Management ICH GCP ICH Guidelines +34

USD 80K+

Partenaire responsable des centres d'étude clinique I / Site Care Partner I
CAN - QC - Remote, Canada

Formation Operational Oversight Outcomes Good Clinical Practice ICH Guidelines Patient Safety Site Management Relationship ICH +26

CAD 92K+

Clinical Research Growth and Partnerships Director
Remote, USA, United States

Technology-driven Cloud-based technology SOP Development Financial Forecasting Operational Management ICH Standard Operating Procedures FDA .Net +25

Exec Senior Full Time

USD 114K+

Clinical Trial Manager, Clinical Operations
US- Remote

Spyre Therapeutics

Study monitoring Informed consent development EU CTR FDA guidelines Vendor selection Good clinical practices Clinical Trial Management ICH Guidelines ICH +10

Senior Full Time

USD 135K+

Manager, Regulatory CMC
New York, New York

Axsome Therapeutics Inc

Ectd Solid oral dosage forms Regulatory cmc Cder guidance Ep USP FDA Submissions CNS Disorders ICH Guidelines +14

USD 95K+

Associate Director, Data Management
Remote, United States

Otsuka Pharmaceutical Companies

CDASH Standards ICH-GCP guidelines Electronic Data Capture SOP Development Impactful Communication Pharmaceutical Development ICH Customer Centricity Coverage +31

Senior Mid Full Time

USD 146K+

Analytical & Strategic Improvements Lead
USA - Pennsylvania - West Point, United States

GMP Compliance Lean tools Analytical Testing Method development Method validation Tech Transfer Technology Transfer Analytical Methods Value Stream Mapping +48

Senior Full Time

USD 206K+

Associate Director, Clinical Scientist - Immunology
USA - Pennsylvania - North Wales (Upper Gwynedd), United States

Deviations PharmD Medical Monitoring Protocols PhD Clinical Studies ICH Immunology Drug Development +47

Senior Mid Full Time

USD 139K+

Manager II, Clinical Trials
Irvine, California, United States

Tarsus Pharmaceuticals, Inc.

Site monitoring Study Management ICH Clinical trials Clinical Research Vendor Management GCP MS Office Teamwork +2

Senior Full Time

USD 131K+

Associate Director, Packaging Development Lead
USA - Pennsylvania - West Point, United States

Quality by design Packaging science Packaging engineering QBD Control strategies CMC ISO Standards Quality System Packaging +51

Senior Mid Full Time

USD 126K+

Director, Program Operations Leader- Hematology
Armonk, United States

Trial Management Clinical Trial Management Operational strategy Strategic direction ICH Standard Operating Procedures Hematology SOPS Clinical operations +21

Senior Full Time

USD 202K+

Senior CRA
Remote (US), United States

Study Management GCP guidelines Data management systems ICH GCP Clinical Monitoring CTMS Site Management Patient Safety Protocols +43

Senior Full Time

USD 105K+

Senior Manager, GPV Aggregate Report & RMP Operations
Remote, United States

Otsuka Pharmaceutical Companies

Risk management plans Safety databases Aggregate reporting Electronic document management systems EDMS Data procurement Document management systems Clinical Management ICH Guidelines +44

Senior Mid Full Time

USD 131K+

Clinical Research Physician Pain
US: USA Remote, United States

Eli Lilly and Company

Medical Leadership Electronic Data Capture Consultative Support Scientific Leadership Medical Monitoring Medical research Good clinical practices Volunteerism Site Management +30

USD 252K+

Senior Manager, Global Case Management, Case Processing - Hybrid
Remote, United States

Otsuka Pharmaceutical Companies

US CFR EU PV legislation Argus Safety Database MedDRA WHO-DD coding Case Processing Global regulations Clinical Case Management Clinical Management +30

Senior Mid Full Time

USD 131K+

Sr. Specialist, Global TMF
Remote (US), United States

TMF management Inspection Readiness ETMF Audit readiness Veeva Vault ICH Standard Operating Procedures Incentive Compensation SOPS +33

Senior Mid Full Time

USD 83K+

Principal Biostatistician, FSP, Late Phase
Durham, North Carolina, United States of America

Multiple imputation methods Analysis plans Clinical trial protocols CDASH Statistical analysis plans SDTM ADaM Iqvia CDISC +23

Senior Full Time

USD 131K+

Associate Director, Study Manager (Immunology)
USA - Pennsylvania - North Wales (Upper Gwynedd), United States

PharmD Ophthalmology Matrix Environment PhD Protocols Operational ICH Clinical Studies Immunology +52

Senior Mid Full Time

USD 139K+

Principal Biostatistician
USA IRV-17011 Redhill/DBC1-5, United States

Edwards Lifesciences

Trial simulations Clinical Affairs Statistical Methodologies Data Quality Assurance Statistical Programming Regulatory Guidelines ICH Statistical methods ISO +31

Senior Mid Full Time

USD 129K+

Manager Clinical Study Lead
Armonk, United States

Case Report Forms Trial Management Selection TMF Patient Recruitment Inspection Readiness Clinical Trial Management CTMS Protocol Development +44

Senior Mid Full Time

USD 126K+

Clinical Field Manager
Your Remote US Home Office

MDR 2017/745 ISO 14155 21 CFR Clinical trial methodology Compliance principles ICH GCP ICH Quality Management System MS Word +18

Senior Full Time

USD 126K+

Associate/Director of Biostatistics, Early Phase Pharmacodynamics
Durham, North Carolina, United States of America

CNS compounds Analysis plans Scientific outreach Clinical development plans Sample size calculations Clinical trial methodology Pharmacodynamics Statistical analysis plans Statistical reporting +45

Exec Senior Mid Full Time

USD 161K+

Director, Clinical Quality and Compliance
USA - Remote, United States

CE IVDR Clinical Compliance Clinical Affairs GLP Smartsheets CAPA Clinical Quality Danaher Business System +26

Exec Senior Full Time

USD 140K+

Mgr, Clinical Data Management - Study Lead
Remote - United States, United States

CDISC standards 21 CFR Part 11 ICH-GCP guidelines Clinical Data Management Matrix Environment Regulatory knowledge ICH Database design Clinical Data +15

Senior Full Time

USD 113K+

Director Clinical Development, Solid Tumors
Remote (US), United States

Medical Support Clinical study design Drug development process Biometrics Translational Research Clinical Study Reports Competitor Analysis Budget planning ICH Guidelines +49

Exec Senior Full Time

USD 239K+

Senior/Director of Biostatistics, Rare Disease, FSP
Durham, North Carolina, United States of America

Clinical development plans Multiple imputation methodologies NDA submissions Statistical problem-solving Clinical trial methodology Sample size calculations ADaM Statistical Methodology Statistical analysis plans +39

Senior Full Time

USD 161K+

Associate Director, Safety Scientist
Cambridge, MA, United States

Sarepta Therapeutics

Safety reporting Signal detection Gene editing RNA Medical Review Gene therapy Pharmacovigilance ICH Regulatory Submissions +12

USD 156K+

Director, Clinical Management (Nephrology)
Remote, United States

Otsuka Pharmaceutical Companies

Financial Estimates Scientific Partnership Clinical Development Plan ICH regulations Regulatory Documents Trial Management Clinical Management Good clinical practices Clinical programs +45

Exec Senior Full Time

USD 183K+

Director, Training and Knowledge Management
Remote (US), United States

GCP Training Training Strategy CAPA Training delivery Knowledge Management ICH Performance Indicators Incentive Compensation Financial excellence +30

Exec Senior Full Time

USD 168K+

Director, Clinical Pharmacology Lead
USA - Pennsylvania - Plymouth Meeting, Amerika Birleşik Devletleri

Biomarker Strategy Modeling and Simulation Pharmacometrics Pharmacodynamics Translational Medicine Pharmacokinetics Clinical Pharmacology Study Design ICH +14

Senior Full Time

USD 150K+

Regulatory Manager
Remote, United States

Precision for Medicine

Clinical Study Interpretation Scientific Advice Drug development process ICH GCP Regulatory strategy Regulatory Guidance Pharmaceutical Development ICH Precision Medicine +21

USD 106K+

Regulatory Manager
Remote, United States

Precision Medicine Group

Clinical Study Interpretation Scientific Advice Timeline development ICH GCP Regulatory strategy Regulatory Guidance Pharmaceutical Development ICH Precision Medicine +25

USD 106K+

Start Up Lead
Remote, United States

Precision for Medicine

Site start-up Critical path planning Budget negotiation ICH Guidelines Documentation Management ICH Precision Medicine Regulatory Submissions Clinical operations +19

Senior Mid Full Time

USD 106K+

Start Up Lead
Remote, United States

Precision Medicine Group

Site start-up Critical path planning Budget negotiation Contracts Management Good Clinical Practice ICH Guidelines Documentation Management ICH Precision Medicine +23

Senior Full Time

USD 106K+

Senior Manager, Regulatory Affairs Device
Cambridge, MA, United States

Sarepta Therapeutics

Global Regulatory Strategy Gene editing RNA Gene therapy Regulatory strategy ICH Guidelines Documentation Management ICH Regulatory Submissions +8

Senior Full Time

USD 132K+

Associate Director, Safety Scientist
Cambridge, MA, United States

Sarepta Therapeutics

Safety reporting Gene editing RNA Signal detection Gene therapy Medical Review Pharmacovigilance ICH Regulatory Submissions +9

USD 156K+

QA Manager, DP Commercial Small Molecule
Remote (US), United States

Small Molecule Quality Risk Management Cross-Department Collaboration CMC CGMP Good Manufacturing Practices Quality Systems Audit Management Incentive Compensation +38

USD 104K+

Clinical Strategy and Solutions Specialist - Study Modeling (Contract)
California, United States - Remote

Faro Health Inc.

Protocol comprehension Study modeling EConsent EPRO TMF IRT ECOA EDC Information Governance +21

USD 100K+

Associate Director, Global Pharmacovigilance Quality Management
Cambridge, MA, United States

Sarepta Therapeutics

Gene editing RNA MS Visio Gene therapy Systems Thinking Pharmacovigilance ICH Regulatory Affairs Quality Management +9

USD 156K+

Associate Director, Medical Writing
Cambridge, MA, United States

Sarepta Therapeutics

Gene editing RNA Scientific Writing Gene therapy SOP Development Medical Writing ICH Regulatory Submissions Clinical Documentation +7

USD 156K+

Associate Director, Analytical Chemistry
Remote Worker

Stability studies Control strategies Analytical reference standards Method optimization Technical investigations Method development Analytical Chemistry Characterization ICH +9

Senior Mid Full Time

USD 165K+

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