Associate Director, Clinical Operations

Role Summary

The Associate Director, Clinical Operations will manage clinical trial activities for multiple trials, ensuring timely completion of deliverables through development, management, and oversight of trial CROs, timelines, and budget. They will partner with Clinical Development and other functions to develop operationally feasible protocols and lead internal study teams as well as outsourced activities. The role includes overseeing study start-up, monitoring, site management, TMF, laboratories, drug supply and data management, and contributing to biostatistics, medical writing, safety, regulatory affairs, and quality assurance as needed. The successful candidate will interact closely with investigators and site staff through routine communication and sponsor visits.

Responsibilities

• Provide strategic planning expertise, define and implement development program strategy and departmental objectives in alignment with corporate goals.
• Responsible for effective global management of multiple clinical studies within a clinical development program.
• Responsible for management of the study teams for assigned studies or programs and of relationships with CROs, central labs, IRB’s, investigating sites and other external partners, as needed, for one or more clinical trials.
• Coordinates the activities of all trial conduct partners and team members and proactively identifies and manages risks
• Determine patient recruitment strategies, operational feasibility and implementation of study/program objectives
• Leads development and/or review of all supporting documents for a clinical study, registry or access program, including but not limited to Protocols, Informed Consent Forms, Investigator Brochures, Study Manuals, Statistical Analysis Plans, CRFs, Data Management Plans and Clinical Study Reports.
• Manage and lead cross-functional clinical trial team meetings collaborating with team members regarding operational activities pertaining to the execution of one or more clinical trial(s)
• Review clinical operations SOPs and work instructions within a program including, but not limited to, new hire training for CTMs/CRCs, tools, templates, and CRO manuals
• Identifies, or assists in identifying, investigational sites and participates in reviewing and approving qualified sites
• Create and review Request for Proposals, vendor specifications and participate in vendor selection process
• Manages the negotiation of contracts, budgets, and timelines with CROs, vendors, clinical sites, and other external partners
• Review study invoices and manage accruals for assigned studies monthly
• Leads the coordination of and training team members and external partners (vendors, sites, etc)
• Prepare and maintain assigned study and program files, study documentation and other essential documents
• Provide management with routine updates regarding the status of ongoing studies
• May participate in internal/external study related audits
• Ensure compliance to internal processes and GCP
• Ensure Trial Master File documentation is collected and maintained
• Attend Investigator Meetings and site visits as needed

Skills

• Ability to manage and operationalize a high volume of highly complex tasks within a given timeline
• Ability to lead cross functional team in a matrix environment
• Strong multi-tasking, time management, and organizational skills
• Ability to take initiative and work both independently and in a team environment

Qualifications

• Minimum 8 years of Clinical Trial Management experience
• Demonstrated knowledge and understanding of FDA/EMA/GCP/ICH regulations and guidelines
• Ability to provide appropriate leadership to clinical sites and CROs
• Detail-oriented individual with good problem-solving capability
• Must be willing to travel, both domestic and international

Education

• Minimum BA/BS Degree

Additional Requirements

• Travel Commitment: 10-20%
• Role Location: HQ, Hybrid or Remote