Associate Director, Global Study Start-Up
The Associate Director of Study Start Up (AD, SSU) will lead all aspects of the day to day activities and support associated with Study and Site Start Up, including the planning, tracking and close out of all related activities and expected results. Ensure the introduction and compliance to standards regarding use of templates, data collection/bring together and document management and will be a steward of new and existing Standard Operating Procedures regarding Study and Site Start Up activities. The AD, SSU is a key liaison with vendors and responsible for setting expectations and leading vendor performance. In collaboration with CTM Leadership and Clinical Study Leads, the incumbent will ensure compliance to Regeneron policies, procedures and Global, regional and/or local regulations. Will directly manage between 3 to 5 individuals.
This role will perform and share Study/Country/Site benchmarking; negotiate Study, country and site milestones with Clinical Study Teams in order to promote setting and managing against realistic timelines for study start up.Job Duties:
- Build and develop a team of individuals who lead Clinical Trial Teams throughout the Study Start Up and Execution stages; includes staff recruitment, onboarding, defining team/work assignments, providing ongoing training and coaching/mentoring, study support/oversight, performance management and professional development.
- Engage and develop strong working relationships with GCO TA Ops Leads, POLs, CSLs, Global Clinical Operations Services, Clinical Drug Supply & Logistics, Vendor & Relationship Management, Strategic Planning & Clin Ops, Contracts & Budgets, Global Monitoring, Clinical Sciences and Regulatory Operations to generate the best outcomes.
- Define the standards and lead all aspects of the planning and execution of Study Start Up, Country requirements and Translation Services to ensure time critical and high-quality delivery of study specific needs.
- Ensure the real time collection of information that better advises Site Activation forecasting and planning and contributes to more accurate Study and Site Start up activities, including the identification and management of key data points required to supervise plans and actuals.
- Contribute to the selection and management of CROs/Vendors; periodically assess the performance of the vendors to promote continuous improvement.
- Periodically supervise compliance to process, quality of results and timeliness, periodically benchmark against the industry and report to partners to promote increased efficiencies in achieving Site Start Up at a global, country and site level.
- Identify, assess, select and contribute to the successful implementation of technology solutions related to Site Engagement, communications, document exchange, delivery of training and relevant data collection requirements in support of Study/Site Start Up activities.
- Author, review and approve applicable SOPs, Work Instructions and training/educational programs; is a designated process steward/owner for the collection, maintenance and oversight of investigator generated documents on a global scale.
- Support any internally sponsored audits as well as any externally scheduled inspections by Regulatory Authorities.
- Supervises site start up staff.
- Experience in clinical drug development process and clinical trial planning and execution practices, including IRB/ERC and Investigator Site roles and responsibilities
- Knowledge and understanding of ICH/GCP and regulatory guidelines/directives, especially ICH E6 R1 and R2
- Experience in leading Sponsor and Site related documents, including the use of CTMS for Site Creation & management, TMF, the Master Index, Sponsor vs. Site requirements
- Knowledge of Clinical Trial insurance policies and procedures
- Familiarity in engaging with and coordinating 3rd party service providers (CROs, Labs, etc.)
- Strong project management skills; multi-task and prioritize in a fast-paced environment
- Strong analytical skills and attention to detail; managing ambiguity; in addition to superior organization skills
- Ability to effectively work across the organization and with outside vendors; Ability to work in a matrix environment; The ability to influence decision making and tactfully push-back; Good team player with a positive attitude
- Good communication and interpersonal skills; Effective problem-solving skills; Strong ability to prioritize and drive for results
- Technical proficiency in MS/iOS applications including (but not limited to) Microsoft Project, PowerPoint/Key Note, Word/Pages, Excel/Numbers, Visio/Lucid Chart, Electronic Document Management Solutions (Veeva, NextDocs, etc.)
- Bachelor’s Degree or higher, preferably in a Life Sciences field;
- 10 to 15 years experience in Clinical Development and preferably, Clinical Operations, including Study and/or Site Management;
- 5 to 7 years managing direct reports.
- Up to 25% travel required.