Position Summary:   

The Associate Director of Clinical Operations is the lead operational contact for clinical studies and provides strategic and operational leadership to the clinical operations team to ensure project milestones delivery on time, within budget, high quality, and in compliance with the ICH/GCP, regulatory authority’s regulations/guidelines, and applicable SOPs.? 

Essential Duties and Responsibilities: 

• Responsible for all operational aspects, strategic input, and progress of clinical trial from study planning to study execution, including ongoing tracking all applicable performance metrics and quality indicators 
• Direct vendor activities to support clinical studies, including vendor selection, budget and contract negotiation, proper guidance of performance for all activities, issue escalation, and invoice management. 
• Oversee study timelines, including all aspects of a trial from contracting through final CSR 
• Provide expertise and operational input into protocol synopsis, final protocol, and other study related documents 
• Oversee study budget planning and management, and accountable for external spend related to study execution 
• Participate in country and site feasibility/selection process, with a focus on providing country insights, corporate agreement, and therapeutic expertise to ensure understanding between study execution plan and program strategy 
• Creates, manages, measures, and reports timelines for milestone deliverables 
• Lead the development of the operational strategy with a focus on ensuring accurate assumptions are applied and risk management plans are in place to ensure a high quality conduct of trials with data integrity 
• Responsible/oversees the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages 
• Ensure studies are "inspection ready" at all time; may be involved in regulatory inspections by preparing for and attending the inspections 
• Represent Clinical Operations in project meetings. Create and foster strong strategic partnerships with colleagues that include Clinical Development, Regulatory Affairs, Statistics, Project Management, Study Monitoring, Drug Safety and CMC. 
• Directly manage data management and other clinical operations team members  
• Ability to prioritize effectively and meet multiple deadlines successfully with attention to detail, setting high performance standards. 
• Leads development, review, and implementation of departmental SOPs, initiatives and processes 
• Ensure all clinical programs are managed in accordance with GCPs and ICH guidelines.   
• Ensure new team members and vendors are onboarded  

Other Duties: 

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. 

Required Education and Experience: 

• BA/BS 
• 7 or more years of clinical research experience in a biotech/pharmaceutical company or clinical research organization (CRO), with a focus on clinical operations. 
• Experience with the following: 
• Developing and writing study protocols, study procedure manuals, informed consent forms, clinical study reports and other study plans/documents 
• Leading outsourced studies across all functional areas (preclinical, stats, data management, and medical writing) 
• Vendor oversight including operations and budget 
• Ability to interpret data 
• Ability to work on complex or multiple projects and exercise independent judgment within generally defined practices and policies lead to obtaining results 

Required Knowledge, Skills, Abilities & Behaviors:  

• Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines 
• Knowledge of principles of quality, safety, risk management, and compliance  
• Verbal and written communications, with the ability to present to internal department meetings and external advisory/investigator meetings 
• Management skills 

Work Conditions: 

• This job operated in a professional office environment.  
• This role routinely uses standard office equipment such as computers, phones, and photocopiers. 
• This position requires you to work occasional nights and weekends to meet company demands.