Senior Study Manager

About the position

We are seeking a highly skilled and experienced Senior Study Manager to oversee the delivery and execution of clinical studies on a global level. This role involves managing a dynamic and ever-changing Pan Tumor Phase II study with multiple stages and patient enrollment requirements. The incumbent will ensure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), FDA regulations/EU Directive, and ICH guidelines.

Responsibilities

• Ensure the delivery execution of clinical studies across multiple geographic regions.
• Maintain routine interaction with key internal and external stakeholders to communicate project status, escalate issues, and troubleshoot routine inquiries.
• Lead the development of the clinical study plan including critical path activities and interdependencies for assigned clinical studies.
• Develop and manage the Clinical Study Oversight Plan (CSOP) and ensure adherence by the study team and vendors.
• Provide operational input into study protocol profiles, final protocols, and amendments.
• Lead the CRO and vendor selection process and manage their performance and compliance.
• Monitor clinical trial performance and quality metrics and take necessary actions to resolve issues or escalate risks.
• Oversee site qualification, initiation, and enrollment activities, and develop mitigation strategies in collaboration with the CRO.
• Coordinate and execute meetings including vendor kick-off meetings, study team meetings, regional team meetings, investigator meetings, and training.
• Review and approve vendor invoices and ensure the study budget is reconciled with Finance.
• Support department in codifying existing knowledge and best practices, and prepare training in areas of expertise.

Requirements

• 7+ years of experience in clinical operations with a Pharmaceutical or Biotech company.
• Experience in clinical trial study start-up, enrollment boosting activities, and overseeing CROs.
• Experience with global studies, including regions such as Asia-Pacific and Latin America.
• Recent oncology solid tumor experience.
• Experience in leading phase II or III global studies.
• Bachelor's degree in Science or advanced degree.
• Excellent written and verbal communication skills.
• Strong decision-making abilities and attention to detail.

Nice-to-haves

• Experience with EU CTR is a plus.
• Experience in protocol amendments.
• Prior experience working for a Japanese company is a plus.
• Prior experience working as a CRA is a plus.
• Ability to adapt quickly to a fast-paced environment.
• Ability to work collaboratively.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)