Job Title: Senior Study Manager

Job Description

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.

Essential Skills

• 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.

Additional Skills & Qualifications

• 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.

Work Environment

This is a 100% remote role, but candidates must be in the Eastern Time Zone or local to the NJ/PA/NY area and open to face-to-face meetings. The work environment is dynamic and requires flexibility and adaptability to changing project needs.