Clinical Trial Capabilities Lead

100 Eli Lilly and Company; Indianapolis (IN); Presencial; USD 66.000 - 154.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k)

Pension plan

Vacation benefits

Descripción de la vacante

Lilly in Indianapolis, IN seeks a Trial Capabilities Senior Associate to provide clinical trial capabilities in support of clinical development. You will ensure investigator sites meet requirements to enroll participants and support site maintenance and close-out.

Responsibilities span initiating investigator activities, handling regulatory documents, negotiating budgets and contracts, maintaining Trial Master Files, and ensuring training and compliance across global sites.

Formación

• Bachelor’s degree preferably in a scientific or health related field.
• Two years clinical research experience or relevant experience preferred.
• Candidates must be legally authorized to work in the United States on a full-time basis.

Responsabilidades

• Initiate investigator activities and submit regulatory documents.
• Customize and negotiate informed consent documents; liaise with ERB/CA where applicable.
• Negotiate and obtain fully-executed contracts; manage investigator budgets.
• Track training and access to clinical systems and supplies for investigators.
• Populate Trial Master Files and related systems; ensure compliance and readiness.

Conocimientos

Lean Six Sigma

Regulatory knowledge

Budget negotiations

Project management

Communication skills

Educación

Bachelor’s degree in science/health field

Descripción del empleo

Lilly in Indianapolis, IN seeks a Trial Capabilities Senior Associate to provide clinical trial capabilities in support of clinical development. You will ensure investigator sites meet requirements to enroll participants and support site maintenance and close-out.

Responsibilities span initiating investigator activities, handling regulatory documents, negotiating budgets and contracts, maintaining Trial Master Files, and ensuring training and compliance across global sites.