Associate Director, Clinical Operations

Role Summary

Associate Director, Clinical Operations. The successful candidate will manage clinical trial activities for multiple trials ensuring the timely completion of deliverables through development, management and oversight of the trial CROs, timeline and budget. Partners with Clinical Development and other functions to develop operationally feasible and clear protocol concepts and final protocols. Must be comfortable independently leading internal study teams, as well as the outsourced activities and responsibilities delegated to CROs and/or other service providers for assigned clinical trials such as, study start-up, monitoring, site management, TMF, laboratories, drug supply and data management, and contribute to biostatistics, medical writing, safety, regulatory affairs and quality assurance activities, where needed. In addition, the successful candidate will interact closely with investigators and site staff through routine calls and site 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, IRBs, investigating sites and other external partners, as needed, for one or more clinical trials.
• Coordinate the activities of all trial conduct partners and team members and proactively identify and manage risks.
• Determine patient recruitment strategies, operational feasibility and implementation of study/program objectives.
• Lead development and/or review of all supporting documents for a clinical study, registry or access program, including 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 coordinating operational activities pertaining to execution of one or more clinical trial(s).
• Review clinical operations SOPs and work instructions within a program, including new hire training for CTMs/CRCs, tools, templates, and CRO manuals.
• Identify or assist in identifying investigational sites and participate in reviewing and approving qualified sites.
• Create and review RFPs, vendor specifications and participate in vendor selection process.
• Manage 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.
• Lead the coordination of and training for 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 with internal processes and GCP.
• Ensure Trial Master File documentation is collected and maintained.
• Attend Investigator Meetings and site visits as needed.

Qualifications

• Minimum BA/BS Degree.
• Minimum 8 years of Clinical Trial Management experience.
• Must be willing to travel, both domestic and international.
• 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.

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.

Education

• BA/BS degree (required).

Additional Requirements

• Travel Commitment: 10-20%.