Senior Clinical Trial Manager: Oncology & Cell Therapy

ADP, Inc.; Rockville (MD); Presencial; USD 130 000 - 166 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Comprehensive benefits plan

401k match

Paid holidays, sick leave, and annual/

Paid time off

Resumo da oferta

AbelZeta is seeking a (Sr.) Clinical Trial Manager to join our Clinical Operations Team in Rockville, MD. Reporting to the Head of Clinical Operations, you will oversee multi-center, Phase 2/3 oncology studies, manage budgets and vendors, and collaborate with clinical, safety, biostatistics, regulatory teams.

This role requires 6+ years of clinical research experience (Masters) or 8+ years (Bachelor), strong GMP/ICH/FDA knowledge, and ability to lead cross-functional CRO teams; domestic travel

Qualificações

• Masters degree and 6+ years of relevant clinical research experience OR Bachelor's degree and 8+ years of relevant clinical research experience
• Experience in developing and implementing standard operating procedures for clinical trials
• Strong knowledge of clinical trial design, regulatory requirements (FDA/ICH)
• Experience in immuno-oncology and cell/gene therapy trials
• Ability to lead multidisciplinary CRO teams and manage budgets/contracts
• Excellent communication and project management skills
• Proficiency with laboratory databases and electronic data capture systems

Responsabilidades

• Innovate and implement clinical trial strategies and protocols
• Lead cross-functional teams to ensure trial execution
• Oversee site selection, recruitment, and monitoring
• Ensure data quality and communication with stakeholders
• Develop and manage trial budgets and timelines
• Manage CRO/vendor relationships and negotiations
• Ensure regulatory compliance (GCP/ICH/FDA) and SOP adherence
• Communicate study progress to investigators and sponsors
• Travel ~25% domestically within the US

Conhecimentos

Clinical trial management

Cross-functional leadership

Budget management

Regulatory knowledge

Data/quality oversight

Formação académica

Masters degree or higher in related field

Bachelor's degree with 8+ years exp

Ferramentas

EDC/eCRF platforms

EMR systems

eTMF platforms

Descrição da oferta de emprego

AbelZeta is seeking a (Sr.) Clinical Trial Manager to join our Clinical Operations Team in Rockville, MD. Reporting to the Head of Clinical Operations, you will oversee multi-center, Phase 2/3 oncology studies, manage budgets and vendors, and collaborate with clinical, safety, biostatistics, regulatory teams.

This role requires 6+ years of clinical research experience (Masters) or 8+ years (Bachelor), strong GMP/ICH/FDA knowledge, and ability to lead cross-functional CRO teams; domestic travel