Senior Clinical Trial Manager

Job Description

The Senior Study Manager will be responsible for ensuring the delivery and execution of clinical studies across multiple geographic regions. This role requires adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), FDA regulations/EU Directives, and ICH guidelines. The incumbent will interact routinely with key internal and external stakeholders to communicate project status, escalate issues, and troubleshoot inquiries. The role involves managing clinical study plans, overseeing CROs and vendors, and ensuring study milestones are achieved within timelines and budget.

Responsibilities

• Ensure the delivery and execution of clinical studies across multiple geographic regions.
• Adhere to Good Clinical Practices (GCPs), SOPs, FDA regulations/EU Directives, and ICH guidelines.
• Communicate project status, escalate issues, and troubleshoot inquiries with key internal and external stakeholders.
• Lead the development of the clinical study plan, including critical path activities and interdependencies.
• Create and manage the cross-functional Clinical Study Oversight Plan (CSOP) and ensure adherence by the study team.
• Provide operational input into study protocol profiles, final protocols, and amendments.
• Lead the document review and coordination for protocols and amendments, including ICF, CRF guidelines, IB, and safety communications.
• Oversee the CRO and vendor selection process and manage the creation of the CRO scope of work.
• Lead trial feasibility and site identification activities in collaboration with the CRO and study team.
• Monitor clinical trial performance and quality metrics, and ensure actions are taken to address any issues or risks.
• Ensure adherence to internal procedures for study planning, conduct, closeout, and reporting.
• Assess potential risks to the study and propose mitigation plans.
• Monitor study budget against trial progress and bring deviations to the attention of the Operations Program Lead and study team leader.
• Review and approve vendor invoices, including investigator grants and pass-through costs.
• Ensure study budget reconciliation with Finance.
• Oversee and manage CROs and third-party vendors to ensure compliance with quality measures and adherence to scope of work within timelines and budget.
• Track operational study timelines and monitor performance metrics throughout the life of the study.
• Coordinate with CROs to prepare and execute meetings, including vendor kick-off meetings, study team meetings, regional team meetings, investigator meetings, and training sessions.
• Oversee CRO study start-up activities and coordinate with functional groups to ensure essential site documents are collected and sites are initiated per study plan.

Essential Skills

• Robust experience in clinical trial study start-up and enrollment boosting activities.
• Experience working with and overseeing CROs.
• Experience working on more than one oncology study.
• Experience with global studies, including regions such as Asia-Pacific and Latin America.
• Experience or awareness of protocol amendments.
• Vendor/CRO oversight and management experience.
• Recent oncology solid tumor experience with indications such as colon, rectal, cervical, GYN, GI, pancreatic, and breast cancer.
• 7+ years of experience with a pharmaceutical or biotech company.
• Bachelor's degree in Science (4-year degree) or advanced degree.
• Experience in clinical operations leading phase II or III global studies.

Additional Skills & Qualifications

• Experience with EU CTR (nice to have).
• Prior experience working for a Japanese company (a plus).
• Prior experience working as a CRA (a plus).
• Ability to adapt quickly to a fast-paced environment.
• Ability to work collaboratively.
• Excellent written and oral communication skills.

Work Environment

Candidates must able to work Eastern Time zone.