Manager Clinical Affairs
$129.6k - $207.4kBecton Dickinson & Co
Becton Dickinson seeks a Manager of Clinical Affairs to oversee clinical trial operations, including site activation, closure activities, and stakeholder coordination. The role manages clinical documentation, regulatory compliance, and cross-functional collaboration throughout the study lifecycle.
Responsibilities
- Oversee planning and execution of clinical trial startup and site closure activities with regulatory and operational accountability
- Prepare, compile, and manage end-to-end study documentation including regulatory submissions and site contracts
- Collaborate with cross-functional teams and investigative sites to ensure timely approvals and protocol adherence
- Provide strategic direction on field and remote monitoring, assess data documentation for protocol compliance
- Lead identification and implementation of process improvements and risk mitigation across competing priorities
Requirements
- Bachelor's degree in Life Sciences, Nursing, or related healthcare field
- 8+ years medical device clinical experience from study design through execution
- 5+ years sponsor-side clinical operations experience
- 5+ years clinical monitoring experience
- Proven experience developing clinical study documents, protocols, and reports
- Expert understanding of clinical operations procedures and regulatory requirements
- Strong cross-functional communication and negotiation skills
$129.6k - $207.4k
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