Temp Associate Director, Clinical Operations (San Mateo County)

Temp Associate Director, Clinical Operations

W2 Contract

Location : Redwood City, CA - Onsite Role

Job Summary :

This role is a unique opportunity for a Clinical Operations Professional. As an Associate Director in Clinical Operations, you will act as a central contact for the Clinical Study Team(s) and assist with the execution and management of clinical trials.

Duties and Responsibilities :

• Adhere to Clinical Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.
• Be a team leader, providing guidance and oversight for successfully managing all aspects of clinical trials within timelines and designated program budgets.
• Review and comment on the development, management, and execution of the Clinical Development Plan (CDP) for assigned clinical programs, including timelines, budget, and resource requirements. Identify critical path activities and articulate and mitigate risks to clinical trial conduct.
• Responsible for successful planning and deployment of Clinical Operations staff (potentially including Clinical Program Managers / Clinical Trial Managers / Clinical Trial Assistants, and consultants) for project and non-project related tasks.
• Line management responsibilities include hiring, performance management, career development, and mentorship.
• Manage / oversee CROs and selected study vendors; ensuring all vendors strive to achieve the predetermined program milestones according to budget and timeline, as well as evaluate vendor performance using metrics and key performance indicators (KPIs).
• Able to pivot, be solution-oriented with consideration to long-term impact on clinical trials, responsibilities, and inspection-readiness.
• Participate in team meetings and collaborate with other functional groups within the company (e.g., Clinical Development, Regulatory, Quality Assurance, Finance, Legal, etc.) to achieve clinical study goals.
• Ensure clinical trials maintain an inspection readiness state throughout the trial's lifecycle.
• Partner with Clinical Operations team members and functional peers to improve processes that will impact clinical trial management and deliverables, including contingency plans.

Requirements and Qualifications :

Preferred Qualifications :

Desired Skills and Experience

Clinical Operations, drug development, project management, clinical trials, FDA Regulations, ICH Guidelines, GCP, vendor management, CRO oversight, eTMF, EDC, IRT, CTMS, Oncology, travel

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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