Sr. Clinical Trial Manager - EMEA
Greater NYC Area (Hybrid)
Compensation: $160,000-182,000 + Bonus + Equity
Company Summary:
We are partnered with one of the hottest biotech's around at the moment that is growing its Clin Ops team ahead of a large phase 3 Oncology trial. This company is founded and led by some of the industries brightest with their C suite coming from the a big pharma company that got the first CAR-T product approved. This company is one that has potential well beyond just one blockbuster drug due to their proprietary drug discovery platform. This platform is rooted in a new way to characterize protein that has led them to much more accurate drug targets. What makes this exciting is that it not only has applications in Oncology, but Neurology and Immunology as well.
Primary Responsibilities:
- Provide guidance and daily oversight for the successful in-house management of all aspects of international clinical trials, ensuring high-quality study data is delivered on time and within budget.
- Develop and execute operational plans for the successful in-house implementation and management of oncology clinical trials.
- Collaborate with cross-functional teams, including data management, clinical scientists, regulatory, and investigators, to ensure operational excellence and rapid delivery of high-quality data. Ability to examine functional issues from a broader organizational perspective.
- Manage all aspects of trial start-up activities, collaborating with other Clinical Operations functions (Site Engagement & Monitoring Excellence, and Supplier Relationship Management & Performance) to deliver efficient and effective site selection, feasibility assessments, and preparation of study-related documentation.
- Collaborate with other Clinical Operations functions (Site Engagement & Monitoring Excellence) to efficiently and effectively deliver study site initiation, training, and monitoring activities to ensure adherence to study protocols, regulatory requirements, and ICH-GCP guidelines.
- Develop and maintain strong relationships with investigators, study coordinators, and study site personnel to facilitate patient recruitment and retention.
- Monitor and evaluate study progress, identifying risks, issues, and deviations, and implement appropriate corrective actions to maintain study integrity and timelines.
- Ensure compliance with regulatory requirements, including ICH-GCP, FDA guidelines, and other applicable regulations throughout the trial lifecycle.
- Collaborate with external vendors, including CROs, central laboratories, and imaging providers, to ensure their efficient and effective deliverables to the trial.
- Contribute to the development and review of study-related documents, such as protocols, informed consent forms, case report forms (CRFs), and standard operating procedures (SOPs).
- Prepare study materials and establish procedures to ensure adherence to study protocols and administrative requirements.
- Lead the creation and maintenance of all study files, including the study master file, and oversight of site files.
- Lead periodic review of the Sponsor Trial Master File.
Qualifications:
- 5+ years clinical operations experience.
- Experience in oncology
- Ability to speak a European Language
