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66 fresh jobs found

Senior Clinical Trial Manager
Remote, United States

Precision Medicine Group

Metric reporting Feasibility Analysis Team dynamics Clinical Trial Management CAPA Audit Preparation Clinical Documentation Invoicing Precision Medicine +45

Senior Full Time

USD 125K+

Senior Pharmacovigilance Operations Manager
South San Francisco, CA, United States

Documentation Management SOP Development Safety management Pharmacovigilance Biostatistics ICH FDA Clinical operations Clinical Development +11

Senior Full Time

USD 133K+

Principal Scientist (ADC), Sterile Drug Product Commercialization
USA - Pennsylvania - West Point

Continuous process optimization Antibody-drug conjugate In-process controls Facility fit Manufacturing science Analytical Technologies Drug Product Commercialization Shelf-life strategies Scale-down +100

Senior Full Time

USD 164K+

Director, Clinical Development, Solid Tumors
Remote (US)

Medical Support Biometrics Clinical study design Translational Research Clinical Study Reports Drug development process Medical Writing Budget planning Protocols +43

Exec Senior Full Time

USD 232K+

Principal GCP Quality Assurance Auditor
Remote, United States

Precision for Medicine

Electronic Clinical Trial Systems CAPA Data sciences Laboratory expertise ICH Guidelines FDA regulations Precision Medicine Self-Motivation ICH +27

Senior Full Time

USD 102K+

Principal GCP Quality Assurance Auditor
Remote, United States

Precision Medicine Group

Vendor Audits Investigator Site Audits Electronic Clinical Trial Systems CAPA Internal Audits Laboratory expertise Data sciences ICH Guidelines FDA regulations +36

Senior Full Time

USD 102K+

Early Development Clinical Research Physician - EMP Immunology & Oncology
US: USA Remote

Eli Lilly and Company

Molecular epidemiology Clinical planning Biopharm studies Digital health technologies Data Dissemination Volunteerism Patient Safety Medical Monitoring Medical research +33

Senior Full Time

USD 198K+

Manager, Central Monitor, Risk Based Monitoring
USA - CT - Remote

Risk-Based Monitoring Signal Management Regulatory operations Database Development Study Design Coverage ICH Data Mining SOPS +16

USD 99K+

CRA (Remote)
Field Non-Sales (USA)

EMEA Clinical Trial Management Site Management ICH FDA Data Collection Clinical trials Clinical Research Medical +15

Entry Mid Full Time

USD 112K+

Senior Clinical Research Associate - Southwest
Remote (US)

Enrollment tracking Data management systems Patient Safety Clinical Monitoring ICH GCP Site Management CTMS Protocols Regulatory Guidelines +37

Senior Mid Full Time

USD 97K+

Associate Director, Clinical Scientist (Athero & Metabolism)
USA - New Jersey - Rahway

Metabolism Medical field External partnerships Study start up Deviations Clinical drug development Medical Monitoring PharmD PhD +53

Senior Mid Full Time

USD 135K+

Safety Specialist II
Remote, United States

Precision for Medicine

Meddra EMA regulations WHO drug Safety database Argus safety database Safety reporting Laboratory expertise Data sciences ICH Guidelines +23

Senior Mid Full Time

USD 72K+

Safety Specialist II
Remote, United States

Precision Medicine Group

Argus safety database Meddra WHO drug EMA regulations Safety database Safety reporting Laboratory expertise Data sciences ICH Guidelines +28

Senior Mid Full Time

USD 72K+

Senior Manager, Clinical Management
Remote

Otsuka Pharmaceutical Companies

Clinical study documents Trial Management Good clinical practices Clinical Management ICH Guidelines Impactful Communication Pharmaceutical Development ICH SOPS +22

Senior Full Time

USD 143K+

Director, Small Molecule Analytical Research & Development GxP Strategic Lead
USA - New Jersey - Rahway

Operational control strategy Pharmaceutical operations Drug delivery technologies Predictive analytical tools Analytical methodologies Process research Drug delivery FDA guidelines Operational Leadership +61

Senior Full Time

USD 149K+

Oncology Medical Writer (Senior Manager/Associate Director)
USA - WA - Remote

EMA Regulatory Interactions Quality review Scientific Writing Regulatory Guidance Medical Writing Coverage Document management ICH +26

Senior Mid Full Time

USD 99K+

Associate Director, Data & Analytics Strategy
USA - New Jersey - Rahway

Dashboard implementation Drug discovery process Project Risk Management GCP guidelines Communications Strategy Clinical trial operations Biological sciences Communication Strategy Data Literacy +52

Senior Mid Full Time

USD 149K+

Senior Manager, Regulatory Diagnostics
Remote (US)

ECTD CTD Regulatory Documentation Regulatory Guidance Protocols Regulatory strategy ICH Guidelines Regulatory knowledge Adobe Acrobat +31

Senior Full Time

USD 135K+

Senior Clinical Trial Specialist
Boston, MA, United States

Recruitment Strategies Inspection Readiness Protocol Development Regulatory Guidelines Biopharma Supplier Management ICH Immunology Clinical operations +13

Senior Mid Full Time

USD 80K+

Principal Biostatistician (Oncology - Clinical Trials)
Remote, United States

Precision for Medicine

Sample size calculation Protocol writing Adaptive design Data Monitoring Statistical Programming ICH Guidelines Study Design Precision Medicine Biostatistics +14

Senior Full Time

USD 133K+

Associate Principal Scientist, Biologics Analytical Research and Development (Onsite)
USA - New Jersey - Rahway

Lab Informatics Separations science Therapeutic proteins Quality attributes Laboratory automation Uplc Scientific publications GLP SEC +73

Senior Mid Full Time

USD 135K+

Principal Biostatistician FSP, Neuroscience
Durham, North Carolina, United States of America

Causal inference methods Rare disease methods Bayesian techniques Synthetic control arms Epidemiologic data Exploratory analyses CDASH Clinical trial protocols ICH GCP +25

Senior Full Time

USD 131K+

SSO Clinical Project Manager (Remote)
Remote Position (USA)

Study Operations Clinical Project Management Feasibility Assessment Timeline Management Patient Engagement ICH FDA Clinical operations People Management +25

USD 158K+

Principal Biostatistician FSP, Pharmacokinetics
Durham, North Carolina, United States of America

PK PD Biomarker analysis Exploratory analyses Biomarker analyses Multivariate analysis Multivariate analyses CDASH Clinical trial protocols +25

Senior Full Time

USD 131K+

Senior Scientist, Clinical Research (Remote)
USA - New Jersey - Rahway

Clinical biomarker assay execution Logistical strategies Biomarker project management Specimen collection Clinical trial execution Data delivery Clinical drug development Flow cytometry Matrixed environment +43

Senior Full Time

USD 111K+

Director, Small Molecule Analytical Research and Development
USA - New Jersey - Rahway

GMP knowledge Quality system experience Development and commercialization Analytical Method Development Analytical methodologies Scientific Methodology FDA guidelines Drug substance Formulation Development +61

Exec Senior Full Time

USD 164K+

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

In-process controls Drug Product Commercialization Facility fit Shelf-life strategies Packaging strategy Site characterization Multivariate analysis CMC regulatory strategy Manufacturing science +85

Senior Full Time

USD 164K+

Principal Biostatistician FSP, Immunology
Durham, North Carolina, United States of America

Exploratory analyses CDASH Multivariate analyses Biomarker analyses Clinical trial protocols ICH GCP CDISC SDTM ADaM +23

Senior Full Time

USD 131K+

Associate Director - Clinical Supply Management
US: USA Remote

Eli Lilly and Company

Clinical Protocol Development Supply Chain Strategies Clinical Supply Management Batch Records Label development Contract Manufacturing Pharmaceutical Development ICH Clinical operations +16

Senior Mid Full Time

USD 111K+

Associate Director, Clinical Scientist - Oncology
USA - New Jersey - Rahway

Clinical drug development Study start up External partnerships Medical field Deviations PharmD Medical Monitoring PhD ICH +52

Senior Mid Full Time

USD 135K+

Senior Scientist, Biomarker Operations, Project Management
USA - New Jersey - Rahway

Logistical strategies Clinical biomarker assay execution Biomarker project management Clinical trial planning Clinical drug development Specimen collection Clinical trial execution Data delivery Flow cytometry +42

Senior Full Time

USD 111K+

Senior Manager, Regulatory Affairs, CMC
Remote (US)

EU Regulatory Requirements Technical Document Authoring Microsoft 360 ICH Requirements US Regulatory Requirements Regulatory strategy Protocols CMC Financial excellence +23

Senior Full Time

USD 133K+

Director, Clinical Science
Remote (US)

Medical Support Clinical study design Biometrics Translational Research Drug development process Clinical Study Reports Scientific Writing Budget planning Protocol Development +49

Exec Senior Full Time

USD 171K+

Associate Clinical Research Medical Director - Oncology RLT (Remote)
Remote Position (USA)

Informed Consent Forms Nuclear Medicine Clinical protocols Recruitment Strategies Clinical trial operations Scientific Expertise Audit Support Patient Engagement Clinical Practice +31

USD 174K+

Medical Director – Early Clinical Development, Oncology
US - California - Thousand Oaks - Field/Remote

Translational science Basic Science Research FDA guidelines Medical Monitoring Regulatory Interactions Spotfire Insight Publications Clinical Data +35

Exec Mid Full Time

USD 251K+

Clinical Trial Specialist
South San Francisco, CA, United States

Recruitment Strategies Protocol Development Inspection Readiness Biopharma Regulatory Guidelines Supplier Management ICH Immunology Clinical operations +13

Senior Mid Full Time

USD 80K+

Clinical Trial Specialist
Cambridge, MA, United States

Recruitment Strategies Protocol Development Inspection Readiness Biopharma Regulatory Guidelines Supplier Management ICH Immunology Clinical operations +13

Senior Mid Full Time

USD 80K+

Associate Director - Reporting, Archiving, Mapping - Hybrid
USA - New Jersey - Rahway

Performance appraisal CFR 21 regulations GCP guidelines Regulatory Approval Clinical Data Management ICH Guidelines Pharmacovigilance Vaccines Standard Operating Procedures +48

Senior Mid Full Time

USD 135K+

Director, Digital Clinical Operations Study Head
Remote (US)

Data Quality Standards Clinical Trial Management Systems Digital Operations Protocol amendments UAT Clinical Systems Study Management Clinical Trial Management CTMS +51

Exec Senior Full Time

USD 168K+

Regional Clinical Trial Management Associate
Remote (US)

Study Management Clinical Trial Management ETMF CTMS ICH Guidelines Financial excellence Document management Distribution Clinical Studies +26

USD 65K+

Principal Biostatistician FSP, Cardiovascular
Bloomington, Illinois, United States of America

Exploratory analyses Multivariate analyses CDASH Biomarker analyses Clinical trial protocols Statistical analysis plans SDTM ADaM ICH GCP +22

Senior Full Time

USD 131K+

Partenaire de l’activation des Centres Cliniques I ou II // Site Activation Partner I or II
CAN - QC - Remote

Good Clinical Practice (GCP) Quality review Good clinical practices FDA regulations Document management ICH Project Coordination Pharmaceutical Industry FDA +14

CAD 60K+

Executive Director, Global Medical Affairs, Breast Disease Area Lead
Remote (US)

Therapeutic area research Clinical study design Biometrics Scientific Communications Drug development process Data Generation Translational Research Budget planning Protocols +40

Senior Full Time

USD 232K+

FSP Principal Biostatistician-Early Phase Oncology
Durham, North Carolina, United States of America

Multivariate analyses Clinical trial protocols Biomarker analyses CDASH Bayesian Methods ADaM Statistical analysis plans ICH GCP SDTM +23

Senior Full Time

USD 122K+

FSP Principal Biostatistician - RWE in Neuroscience
Bloomington, Illinois, United States of America

Clinical trial protocols ICH GCP Observational Research Health Economics Real-World Evidence Analytic Biostatistics Regulatory Submissions ICH +19

Senior Full Time

USD 131K+

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

Scale-Up Processes Drug Product Commercialization Characterization Studies Life cycle management CMC regulatory strategy Performance qualification QbD principles Manufacturing science Process Performance +93

Senior Mid Full Time

USD 135K+

Country Clinical Quality Manager, US - Remote
USA - New Jersey - Rahway

Clinical trial processes Clinical Quality Management Clinical supplies Clinical Supply QMS Learning & Development Quality Management System Qualification Standard Operating Procedures +53

Senior Full Time

USD 135K+

Clinical Operations Manager - Finance (REMOTE)
USA - New Jersey - Rahway

Clinical trial operations Site Management Negotiations Conflict Management Pharmacovigilance ICH Quality Standards Database Clinical operations +54

USD 111K+

Principal Scientist - Mixed Modalities, Sterile Product Development
USA - New Jersey - Rahway

Parenteral dosage forms Formulation science DOE studies QbD principles Drug product development Intermediate modalities Parenteral drug products Drug product Equipment design +71

Senior Full Time

USD 149K+

Field Medical Affairs Scientist, level I or II, Oncology / Scientifique des affaires médicales régionales, niveau I ou II, Oncologie
CAN - ON - Remote

Promotional Health sciences Field Medical Clinical Studies ICH Pharmaceutical Industry Medical Affairs Regulatory requirements Creativity +15

CAD 89K+

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