Director/Associate Director, Clinical Operations

Essential Functions and Responsibilities

Responsible for growing and managing projects, and daily work activities for the Clinical Team.

Independently manage all components of complex oncology clinical trials, leading a cross-functional management team.

Ensure clinical trial activities and deliverables are completed on-time and within budget

Vendor oversight (e.g., CRO, PK/Central Lab, Drug Supply, IXRS, eTMF) for adherence to budget, timelines, and organizational objectives of individual protocols/programs.

Develops strong vendor relationships and ensures continuity of relationships through all phases of the trial.

Involved in the identification, evaluation, selection, and oversight of all clinical trial sites.

Oversee and participate in development of study documents and tools including study protocols, consent forms, and project plans

Obtains and maintains in-depth understanding of the study protocol and related procedures to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement, and providing training as appropriate/required.

Partner efficiently and effectively with clinical trial sites to ensure smooth study conduct

Ensure efficient study enrollment and high-quality monitoring activities at participating clinical sites

Coordinates & manages various tasks in collaboration with other sponsor roles to achieve site readiness, such as study materials and approval for drug shipping/receipt according to procedure.

Develop processed and provide oversight of study supplies management

Performs timely review of monitoring reports from CRO and associated deliverables demonstrating sponsor oversight.

Oversee ongoing study data reviews and data cleaning activities.

Responsible for inspection readiness at all times. Perform periodic reviews of the CRO eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines.

Works with vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.

Supports financial management of the study which includes review and approval of site and vendor invoices.

Supports Risk Management initiatives

Maintain clinical trial registry entry/updates, as required.

Conduct/attend internal/external meetings for assigned clinical trials

Provide study status updates, including presentations and reports to senior management

May develop SOPs, best practices, and facilitate their implementation

Education, Experience, Knowledge, Skills and Abilities

BA/BS in related scientific or healthcare field, a combination of relevant education and applicable job experience may be considered .

8-10 years of clinical trial management experience.

Experience in running a trial from start to finish; initiating the trial; ICF generation, site feasibility/start up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out.

Excellent communication skills, including the ability to understand and present technical information effectively.

Strong understanding and working knowledge of clinical research, phases of clinical studies, current ICH GCP, FDA regulations, & country clinical research law & guidelines.

Strong understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

Strong leadership, effective decision making, and problem-solving skills required.

Hands on knowledge of Good Documentation Practices.

Performs independently and professionally when managing both site/vendor oversight and monitoring responsibilities, and as applied across multiple protocols, sites, and therapeutic areas.

Strong IT skills (Use of MS office, use of various clinical IT applications on computer, tablet, and mobile devices) and ability to adapt to new IT applications on various devices.

Ability to understand and analyze data/metrics and act appropriately.

Possesses effective time management, organizational and interpersonal skills, conflict management, problem- solving skills.

High sense of accountability/urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.

Works effectively in a matrix cross-functional environment. Ability to establish and maintain culturally sensitive working relationships.

Previous oncology experience required and experience with solid tumors and immunotherapy/biologics preferred.

Ability to travel up to 15%.

Benefits

Competitive compensation package including base salary, annual bonus, stock options and 401k.

Competitive benefits package in healthcare, life insurance, and paid time off.