1. Responsibilities

1.1 Manage clinical studies; ensure conducted in a timely manner and according to good clinical practice and all applicable regulatory requirements, SOP, and other quality standards; Facilitates and collaborates with internal and external stakeholders in support of clinical program objectives.

1.2 Lead sponsor study startup process, including but not limited to conduct of vendor selection/set up, Trial Kick-off meeting, TMF set up, Site identification, qualification and selection, Finalization of site and vendor Clinical Trial Agreements and budgets.

1.3 Conducts site and study training; ensures ongoing study team training maintained; identify opportunities to improve training and study execution across the clinical team.

1.4 Ensure potential study risks are escalated to management when appropriate.

1.5 Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.

1.6 Review and approve the development of study related material like study manuals, questionnaires, synopsis, study presentations (Study Plans, Cell Manual, Training Materials, Site Level documents, site logistic plans).

1.7 Oversee slot planning and dosing are aligned meet enrollment goals; oversee slot assignments and to ensure collection and review of eligibility documents is conducted per protocol and IHC requirements.

1.8 Provide efficient updates on trial progress to management, with respect to vendor selection, project plans, trial budget and timeline, quality standards and risk mitigation.

1.9 Coordination of Investigator Meetings at the study level.

1.10 Ensure project plans are in place and operational for each trial and work proactively to set priorities in accordance with applicable project plans, company SOPs, ICH/GCP guidelines and regulatory requirements.

1.11 Chair vendor status update meetings and ensure meeting minutes are completed, distributed to team members and filed in the Trial Master File (TMF) in a timely manner.

1.12 Monitor the quality of vendor deliverables, address quality issues with vendors and identify opportunities to improve vendor collaborations.

1.13 Ensure cross functional integration of study deliverables meet quality and timeline requirements for the study.

1.14 Ensuring all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures.

1.15 Review and approve vendor invoices and ensure investigator payments occur in a timely manner; manage budget scope and vendor contract changes required to meet study deliverables;

track/maintain study financials. 1.16 Provide support for CTLs and other team members assigned to the study team.

1.17 Other duties as assigned.

2. Qualification

2.1 Bachelor’s degree in the life sciences (biology, physics, chemistry, healthcare, pharmacy, etc. Master’s degree is preferred.

2.2 At least 4 years of oncology project management experience is required.

2.3 Pharmaceutical and/or clinical drug development experience are preferred.

2.4 Strong understanding of FDA regulations, GCP, ICH guidelines and clinical research SOPs.

2.5 Excellent organizational skills and ability to prioritize and multitask.

2.6 Knowledgeable across clinical monitoring and data services functions.

2.7 Excellent communication, leadership, relationship building and interpersonal skills.