Arrowhead PharmaceuticalsNASDAQ: ARWR: Develops RNAi medicines to treat genetic and intractable diseases.
2+ YOEBachelor's degree, ≥2 years clinical operations experience, ≥1 year eTMF setup/maintenance, knowledge of FDA ICH-GCP, strong communication and organizational skills; Veeva Vault eTMF and MS Office preferred.
eTMF, Veeva Vault eTMF, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
Structure TherapeuticsNASDAQ: GPCR: Developing oral small molecule medicines for chronic diseases
8+ YOE2+ Mgmt8–10 years in clinical research; expertise in eTMF governance and regulatory compliance; CRO/vendor oversight; strong leadership and cross-functional collaboration.
SystImmune: Developing multi-specific antibodies and antibody-drug conjugates for cancer therapy
5+ YOEBachelor's degree; 5-8 years in clinical study start-up/regulatory submissions; oncology trials; CTMS/eTMF proficiency; strong negotiation and leadership.
Vanguard Clinical: Provides boutique clinical research services for biotech and pharma companies.
3+ YOE3+ years clinical research; proficient in eTMF/EDC/CTMS/IWRS; strong ICH-GCP/GDP knowledge; able to manage multiple tasks with minimal supervision.
Codera: Provides end-to-end drug development services for biotechnology companies.
3+ YOEBachelor's in life science required, 3+ years site monitoring experience, FDA/ICH/GCP knowledge, CTMS/eTMF experience preferred, willing to travel 50–65%.
Alexion Pharmaceuticals: Develops and manufactures treatments for rare and ultra-rare diseases.
3+ YOEBachelor's degree in life science, ~3 years clinical operations or study support experience, proficiency with MS Office, CTMS and eTMF, strong organization, communication, and collaboration skills.
Microsoft Excel, Microsoft Word, PowerPoint, CTMS, smartsheets, eTMF
ProPharma: Provides clinical, regulatory, and compliance services to life sciences.
5+ YOEBachelor's degree, >5 years CRA experience, knowledge of ICH/GCP and local regulations, EDC/CTMS/IVRS/eTMF experience, strong communication and MS Office skills.
Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, EDC, CTMS, IVRS, eTMF
Boston ScientificNYSE: BSX: Developer and manufacturer of innovative medical devices and therapies.
8+ YOE3+ MgmtBachelor's degree, 8+ years in clinical operations/data/analytics with 3+ years leading teams; experience with CTMS/EDC/eTMF, clinical reporting, GCP, and stakeholder influence.
CTMS, EDC, eTMF, Microsoft Power BI, Tableau, Spotfire, SQL, Snowflake
Senior Director, Global Clinical Operations and Medical Writing Technology
Boston, Massachusetts, United States
$228k-$342k/yrHybridFull Time
Vertex PharmaceuticalsNASDAQ: VRTX: Develops and sells prescription drugs for serious genetic diseases.
10+ YOE10+ years biotech/pharma IT and operations; leadership of clinical operations and medical writing tech; SaaS, AI, Veeva CTMS/eTMF; project/program management; Bachelor's degree.
Bristol Myers SquibbNew York Stock Exchange: BMY: Develops and distributes innovative medicines for serious diseases.
4+ YOE4+ years in clinical data management in pharma/biotech/CRO; experience with EDC/CTMS/eTMF; oncology preferred; manage CRO relationships; strong GCP/CDISC knowledge.
ImmaticsNASDAQ: IMTX: Develops T-cell receptor-based immunotherapies for cancer treatment.
4+ YOEBS life sciences or nursing; 4+ years on-site monitoring; strong knowledge of ICH-GCP, FDA/EMA; site management and trial documentation; CTMS/eTMF proficiency.
SAB BiotherapeuticsNASDAQ: SABS: Developing human antibody-based immunotherapies using a bovine platform.
6+ YOEB.S. degree,6+ years clinical trial management experience,GCP and FDA/EMA/MHRA knowledge,experience with EDC/CTMS/eTMF and MS Office,leadership and budgeting skills.
EDC, CTMS, eTMF, Veeva, Agatha, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Smartsheet
iuvo Clinical: Specialized ophthalmology contract research organization and clinical trial provider.
Clinical site start-up and essential document management experience; familiarity with eTMF/Veeva and Microsoft Office; strong communication, organization, and regulatory knowledge (ICH/GCP, SOPs). Bachelor's preferred.
eTMF, Veeva, Microsoft Word, Microsoft Excel, Microsoft Outlook, Microsoft Teams
UBC: Providing clinical and commercialization services for the biopharmaceutical industry.
3+ YOE3+ years on-site monitoring experience, bachelor's in life science preferred, knowledge of medical terminology and regulations, CTMS/eTMF/EDC and Microsoft Office experience, strong communication and critical thinking.
Boston ScientificNYSE: BSX: Manufacturer of interventional medical devices and technologies.
8+ YOE3+ MgmtBachelor\u0002s degree, 8+ years in clinical operations/data/analytics, 3+ years managing technical teams, experience with CTMS/EDC/eTMF and clinical reporting, strong leadership and communication.
CTMS, EDC, eTMF, Microsoft Power BI, Tableau, Spotfire, SQL, Snowflake
Sagimet BiosciencesNasdaq: SGMT: Develops oral FASN inhibitor drugs for metabolic and inflammatory diseases.
2+ YOE2+ years clinical research experience preferred, bachelor’s in life sciences/healthcare preferred, strong organizational and communication skills, familiarity with CTMS/eTMF and Microsoft Office, knowledge of ICH-GCP.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, CTMS, eTMF, EDC
ADARx Pharmaceuticals: Develops RNA-targeting therapeutics for treating genetic and cardiometabolic diseases.
5+ YOE5+ years clinical trial administration experience, GCP/ICH/FDA knowledge, BS/MS in life or health sciences, experience with EDC/CTMS/eTMF/IWRS, strong communication and organizational skills.