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
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%.
Neurocrine BiosciencesNASDAQ: NBIX: Develops pharmaceuticals for neurological, endocrine, and psychiatric disorders.
Bachelor's degree and relevant clinical research experience; knowledge of GCP/ICH/FDA regulations; experience with CTMS/EDC/IWRS/eTMF preferred; strong communication, organization, and problem-solving skills.
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
BiVACOR: Developing an advanced total artificial heart for patients.
3+ YOE3–5+ years clinical operations/site management in medical device/pharma; ICH-GCP and FDA IDE familiarity; CTMS/eTMF proficiency; regulatory binders and supply logistics; willingness to travel.
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.
Clinical Research Associate (CRA) - Cardiovascular/Vaccine/Infectious Disease- Remote
Rahway or New York City or Florida or Bloomington or Chicago or Naperville or Peoria or Flagstaff or Phoenix or Tucson or California or Colorado or Dallas or Houston
$96k-$151k/yrFieldFull Time
Merck & Co.NYSE: MRK: Produces prescription medicines, vaccines, and animal health products.
2+ YOE2+ years direct site management (monitoring) experience required, strong GCP/ICH knowledge, ability to travel ~65-75%, current driver’s license, fluent English, CTMS/eTMF experience.
CTMS, eTMF, Microsoft Office, Adverse Event Reporting System
Verily: Developing data-driven technologies for clinical research and precision health.
4+ YOEBachelor's or equivalent,4+ years clinical operations experience,experience drafting protocols/ICFs and managing eTMF,SME in cross-functional teams,project management skills; JIRA and PM certification preferred.
Project Manager I – Cell & Gene Therapy (Sponsor Dedicated)
Los Angeles, California, United States
$81k-$145k/yrRemoteFull Time
Syneos Health: Global biopharmaceutical services for clinical development and commercialization.
2+ YOE2+ years clinical trial experience (CRO preferred), CAR-T/cell therapy experience desirable, familiarity with GCP/ICH and FDA/EMA, bachelor’s degree or equivalent, proficiency with CTMS/EDC/eTMF.
5+ YOEBachelor's degree in life sciences, 5+ years clinical research/operations experience, ICH/GCP knowledge, site relationship management, CRO oversight, eTMF/Veeva familiarity, and willingness to travel 30-50%.
Novotech: Global clinical research services for biotech drug development.
5+ YOEGraduate in clinical or life sciences; 5+ years clinical research experience with project management experience; CRO experience advantageous; knowledge of ICH GCP, CTMS, eTMF, vendor and budget management; risk mitigation and regulatory submissions.
ArdelyxNASDAQ: ARDX: Discovers and develops medicines for unmet medical needs.
2+ YOEBachelor's in a scientific/related field with 2+ years in clinical operations/clinical research or equivalent; knowledge of clinical trial lifecycle and ICH-GCP; experience with EDC/CTMS/eTMF; Microsoft Office proficiency; ability to travel as needed.
EDC, CTMS, eTMF, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, Smartsheet
Arcus BiosciencesNYSE: RCUS: Develops differentiated molecules and combination therapies to treat cancer.
5+ YOEBachelor's degree preferred,5+ years industry experience with 2+ years trial management,knowledge of ICH GCP,experience with EDC/IRT/CTMS/eTMF,strong communication,organization and Microsoft IT skills,10-20% travel.
CareDxNASDAQ: CDNA: Develops diagnostic tests and digital tools for transplant care.
4+ YOEBachelor's in life/health sciences (or equivalent experience); 4+ years clinical trial management and 2+ years CRA experience with monitoring; strong knowledge of ICH/GCP and FDA regulations; experience with eTMF, CTMS, EDC, Medrio, Medidata and Microsoft Office.
Electronic data capture (EDC), Medrio, Medidata, eTMF, CTMS, Microsoft Excel, Microsoft Word, Microsoft Outlook, Microsoft PowerPoint
El Segundo or Los Angeles or San Diego or San Francisco or New York City or Chicago or Boston
$128k-$136k/yrRemoteFull Time
ImmunityBioNASDAQ: IBRX: Develops next-generation immunotherapies for cancer and infectious diseases.
6+ YOEBachelor's degree (or RN with 5+ years monitoring),6+ years clinical trial experience,4+ years on-site/remote monitoring,valid driver's license,knowledge of ICH‑GCP,EDC/eTMF/CTMS and MS Office,ability to travel 50–75%.
EDC, eTMF, CTMS, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, Adobe
AbbVieNYSE: ABBV: Develops and sells innovative pharmaceutical and biopharmaceutical medicines.
8+ YOEBachelor's degree required; 8+ years clinical research study management; leadership and cross-functional experience; experience with drug/device/interventional studies and end-to-end study operations; familiar with ICH/GCP and clinical trial systems (EDC, IRT, CTMS, eTMF).
Palo Alto or Princeton or Miami or California or New Jersey or United Kingdom or Ireland
$117k-$137k/yrOnsiteFull Time
Summit TherapeuticsNASDAQ: SMMT: Developing oncology therapies to improve patient quality of life.
4+ YOEBachelor's degree in biological, health, or medical sciences or equivalent experience; 4+ years in a CRO or pharmaceutical clinical study environment; CTMS and eTMF experience; FDA, GCP, and ICH knowledge.
Clinical Trial Management Systems (CTMS), Clinical Trial Master File Systems (eTMF), CTMS, EDC
Maze TherapeuticsNASDAQ: MAZE: Develops genetic-based precision medicines for renal and cardiovascular diseases.
6+ YOEBachelor's degree in life sciences, healthcare administration, or related field; 6–8+ years in clinical operations or TMF management; 4–5+ years managing global eTMFs; GCP and inspection-readiness expertise.
AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
0+ YOEBS in life sciences preferred; 0–1 years CRA/CRC/CTA experience (or 2 years combined experience); knowledge of CFR and ICH-GCP; clinical device/IVD study experience preferred; strong communication and teamwork; Microsoft Suite proficiency.