Temp Associate Director, Clinical Operations

Temp Associate Director, Clinical Operations

W2 Contract Location:

Redwood City, CA - Onsite Role Overview

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. Responsibilities

Adhere to Clinical SOPs, Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) Guidelines. Provide leadership and oversight for 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. Plan and deploy Clinical Operations staff for project and non-project tasks (e.g., Clinical Program Managers/Clinical Trial Managers/Clinical Trial Assistants, and consultants). Line management responsibilities including hiring, performance management, career development, and mentorship. Manage/oversee CROs and selected study vendors; ensure vendors meet program milestones within budget and timeline; evaluate vendor performance using KPIs. Be solution-oriented with consideration of long-term impact on trials, responsibilities, and inspection readiness. Participate in team meetings and collaborate with Clinical Development, Regulatory, Quality Assurance, Finance, Legal, and other functions to achieve study goals. Ensure clinical trials maintain an inspection readiness state throughout the lifecycle. Partner with team members to improve processes that impact trial management and deliverables, including contingency planning. Qualifications

Bachelor's degree in biological sciences or a health-related field. 10+ years of direct Clinical Operations experience in the pharmaceutical or biotech industry. Relevant indirect experiences may also meet the requirement. Minimum of 4 years of project and line management experience. Extensive experience leading and managing global phase 1-3 clinical trials within timelines, resources, and budgets. Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP. Experience with vendor management and CRO oversight. Ability to perform complex analysis, draw relevant conclusions, and implement solutions. Strong analytical, negotiation, and interpersonal skills. Ability to handle time demands, incomplete information, or unexpected events. Outstanding organizational skills with the ability to multitask and prioritize. Excellent verbal and written communication skills. Comfortable in a fast-paced environment and able to adjust workload based on priorities. Proficiency in Microsoft Office; MS Project and/or Smartsheet a plus. Travel may be required (~25%). Preferred Qualifications

RN or Master’s degree in biological sciences or a health-related field preferred. Familiarity with vendor systems/portals (eTMF, EDC, IRT, CTMS). Oncology experience, early and/or late stage, strongly preferred. Knowledge of Ex-US region clinical trial operations. Experience with cooperative group studies and investigator-sponsored trials is preferred. 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 Note: Bayside Solutions, Inc. cannot sponsor candidates at this time. This position requires a W2 candidate. You may be asked to provide Bayside Solutions, Inc.reedom policy per privacy policy information as described in Bayside Solutions, Inc.s CCPA Privacy Policy. Job Functions

Project Management, Research, and Science

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