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Clinical Operations Lead
- San Francisco, California, United States
- San Francisco, California, United States
Über
Pay Range: $77.90hr - $82.90hr
Job DescriptionThe Clinical Operations Lead supports operational activities that enable the successful execution and delivery of clinical studies and programs across disease areas. The role contributes operational and strategic input to clinical teams, ensures regulatory compliance, and collaborates with investigators, clinical sites, and cross-functional teams to support the efficient execution of clinical trials.
Requirement/Must Have- Knowledge of drug development and clinical operations.
- Understanding of ICH, GCP, and regulatory guidelines for clinical trials.
- Strong organizational and problem-solving skills.
- Ability to collaborate across cross-functional teams and geographies.
- Strong communication and stakeholder engagement skills.
- Two to five years of relevant experience in clinical operations or related areas.
- Experience supporting clinical trial execution and operational activities.
- Experience collaborating with investigators, clinical sites, and internal teams.
- Experience working in environments requiring adaptability and collaboration.
- Contribute to operational activities that support the execution and delivery of clinical studies and programs.
- Provide operational and strategic input to clinical teams across disease areas.
- Support local and global clinical initiatives based on business priorities.
- Ensure adherence to regulatory requirements including ICH and Good Clinical Practice guidelines.
- Promote quality and compliance through focus on data integrity and risk-based approaches.
- Plan and coordinate operational activities related to clinical operations programs and studies.
- Collaborate with cross-functional teams to implement best practices across clinical operations.
- Build subject matter expertise by supporting clinical trial execution and project activities.
- Apply organizational and problem-solving skills to support operational planning and execution.
- Serve as a resource for colleagues across projects with moderate complexity.
- Support the adoption of digital technologies in clinical studies by investigators and patients.
- Participate in continuous improvement and change management initiatives.
- Develop plans to support clinical trials and operational projects with appropriate guidance.
- Work closely with investigators and clinical site staff to maintain strong partnerships.
- Contribute to prioritization activities to align operational efforts with short-term and long-term goals.
- Clinical trial operations and coordination.
- Regulatory compliance and quality management.
- Project planning and operational management.
- Communication and stakeholder collaboration.
- Change management and continuous improvement.
- Bachelors degree in life sciences, healthcare, or a related field or equivalent experience.
Sprachkenntnisse
- English
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