1mo
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Head of Study Start-Up
United States
RemoteFull Time
10+ YOE10+ years in clinical research with significant CRO and study start-up experience; proven people leadership, regulatory knowledge (FDA/EMA/ICH-GCP), stakeholder management, and financial acumen.
3mo
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Experienced Study Start-Up Coordinator
Cincinnati, Ohio, United States
OnsiteFull Time
1+ YOEBachelor's degree required (preferably life sciences), 1+ years' experience in study start-up or as a study coordinator, strong organization and communication skills, knowledge of Microsoft Office, and experience handling regulatory submissions and TMF documents.
Microsoft Office
1mo
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Experienced Study Start-Up Coordinator
Cincinnati, Ohio, United States
OnsiteFull Time
1+ YOEBachelor's degree, 1+ years study coordinator/pharma start-up experience preferred, strong organization, attention to detail, Microsoft Office knowledge, excellent communication.
Trial Master File (TMF), Microsoft Office
3w
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Clinical Study Start-Up Associate
Boston, Massachusetts, United States
$90k-$110k/yr HybridFull Time
3+ YOEBachelor's in life sciences/healthcare required, 3+ years supporting clinical trials with study start-up experience, ICH-GCP knowledge, TMF/CTMS/eTMF experience, strong organization and communication, Microsoft Office proficiency.
CTMS, eTMF, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Outlook
4d
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Associate Director, US Study Start-Up
United States
$130k-$216k/yr RemoteFull Time
5+ YOEUniversity degree in sciences or equivalent,5+ years clinical operations experience,knowledge of ICH-GCP and US study start-up,leadership and stakeholder skills,experience reducing start-up timelines.
1w
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Study Start-Up Associate II
Rockville or United States
RemoteFull Time
1+ YOEBachelor in life/health sciences or related; 1+ year pharma/CRO experience preferred; knowledge of study startup, regulatory submissions, and MS Project/Word/Excel; strong communication and organizational skills.
Microsoft Project, Microsoft Word, Microsoft Excel
1mo
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Study Start Up Specialist
Loma Linda, California, United States
$26-$33/hr HybridFull Time
2+ YOEBachelor's in a health-related field (or equivalent experience), 2+ years clinical research experience, familiarity with HCPCS/CPT coding preferred, knowledge of FDA/Medicare trial regulations, and proficiency with Microsoft Office and EMR.
Microsoft Word, Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint
2w
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Director, Clinical Operations Study Start-Up
Palo Alto, California, United States
$203k-$253k/yr OnsiteFull Time
15+ YOE5+ Mgmt15+ years pharma/biotech experience with study start-up for global Phase 3 trials, 5+ years managerial experience, BA/BS (graduate degree preferred), strong regulatory, CTMS/eTMF, vendor oversight, and leadership skills.
eTMF, CTMS
1mo
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Senior Manager Global Study Start Up
Warren or Armonk
$134k-$219k/yr OnsiteFull Time
8+ YOE2+ Mgmt8+ years in clinical trial start-up, leadership, site start-up management, CTMS/TMF proficiency, regulatory knowledge.
CTMS, TMF, Microsoft Office
3mo
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Study Start-Up Coordinator- PharmD
Cincinnati, Ohio, United States
OnsiteFull Time
0+ YOEPharmD required; 3.5+ GPA preferred; some office experience; strong organization, MS Office, and communication skills.
Microsoft Office
2mo
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SCI-CTO Study Start-UP Project Manager (Hybrid)
Stanford, California, United States
$86k-$100k/yr HybridFull Time
2+ YOEBachelor's degree and 2 years clinical research experience (or equivalent); knowledge of clinical trials data management, HIPAA/FDA/IRB/GCP, Microsoft Office and database applications; strong interpersonal and communication skills; thoracic clinical knowledge preferred.
Microsoft Office
2w
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Manager Study Start-up
Aliso Viejo or San Clemente or Burlington or United States
$130k-$163k/yr OnsiteFull Time
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.
3d
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Senior Regulatory Affairs Study Start Up Specialist
Covington, Kentucky, United States
HybridFull Time
5+ YOEAssociate's or Bachelor's in allied health or equivalent experience; 5+ years regulatory experience in pharmaceutical/site/CRO; knowledge of IRB/EC/CA submissions, regulatory documentation, and audit preparation.
XML, TMF, Microsoft Teams
1mo
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Study Start Up Operations Manager - Full Time - Wolf River - Registered Nurse (RN)/ Licensed Practical Nurse (LPN) Experience Required
Germantown, Tennessee, United States
OnsiteFull Time
2+ YOECurrent RN or LPN license, 2+ years clinical research experience, knowledge of FDA/ICH-GCP and study start-up processes, leadership/supervisory experience, proficiency with Microsoft Office and CTMS preferred.
Microsoft Excel, Microsoft Word, Microsoft Outlook, Adobe Acrobat, CTMS
1mo
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Regulatory Start Up Associate - Shanghai
Shanghai or China or United States or Europe
OnsiteFull Time
0+ YOEGraduate in clinical/pharmacy/life sciences or 0–2 years CRO/pharma/clinical experience. Knowledge of ICH-GCP, preparing regulatory and ethics submissions, managing timelines, reviewing study documents, supporting budgets and translations.
1w
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UNIV - SISU Start-Up Manager & Protocol Writer - Hollings Cancer Center
Charleston, South Carolina, United States
$66k-$120k/yr OnsiteFull Time
3+ YOEBachelor's degree and 3+ years relevant experience; knowledge of GCP, CFR, FDA/IRB processes; protocol writing, study start-up, regulatory submissions, and clinical trials systems.
OnCore, eReg, clinicaltrials.gov
2mo
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Associate Director, Study Start Up
San Diego, California, United States
$160k-$230k/yr OnsiteFull Time
5+ YOEBachelor’s degree; 5+ years clinical trial experience; 3+ years feasibility/start-up; CTMS/eTMF experience; Veeva preferred; strong site management and regulatory knowledge.
CTMS, eTMF, Veeva Systems, Microsoft Word, Microsoft Excel, PowerPoint
2mo
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Director, Study Start-Up
Watertown, Massachusetts, United States
$195k-$275k/yr OnsiteFull Time
10+ YOE10+ years in biotech/pharma with Clinical Operations project management; strong regulatory, ICH-GCP, process improvement, and cross-functional leadership.
GCP, Regulatory systems, Contract management
2mo
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Senior Study Startup Specialist
Princeton, New Jersey, United States
$90k-$115k/yr HybridFull Time
5+ YOEBachelor's degree; 5-8 years in clinical study start-up/regulatory submissions; oncology trials; CTMS/eTMF proficiency; strong negotiation and leadership.
CTMS, eTMF, clinical trial platforms
1mo
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Local Study Associate Director- FSP
United States or North Carolina
RemoteFull Time
3+ YOEOncology-experienced LSAD (cell therapy preferred) with 3+ years in Development Operations (CRA/SrCRA). Leads local study teams, manages site start-up/monitoring, ensures ICH-GCP compliance, bachelor's preferred, national/international travel required.
CTMS, eTMF
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