Associate Director Global Study Start-Up - Systems & Information Management

The Associate Director of Study Start Up (AD, SSU) will be responsible for the development and evolution of Information Management strategies required to support Study Start Up activities. Included is the implementation and daily support of the European Union Clinical Trials Regulation (EU CTR) practices associated with preparing mutually recognized Clinical Trial Application according to Member State requirements within the EMA CTIS database. The management of the Country Start Up Playbook will also fall within the scope of responsibilities in support of Study start up benchmarking and Clinical Study Team study milestone planning. Ownership of the Investigator Alert Letter (IAL) solution and process will also be in scope, as well as, the Investigator Site Directory and the Investigator List creation requests from Clinical Study Teams from the time of Site Identification through to Site Closure. Any additional technologies developed and deployed in support of direct engagement with site personnel will also fall within scope of responsibilities. The AD SSU will directly lead between 8 to 10 individuals who support Site Start Up activities. Up to 25% travel required.

• Builds and leads a team of individuals who support 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.

• Engages and develops strong working relationships with Clinical Operations, Contracts & Budgets, Global Monitoring, Supplies & Logistics, Legal and Regulatory Operations to generate the best outcomes.

• Defines the standards and supervises the planning and execution of Study Start Up, Country requirements and country/site information management activities to ensure time critical and high-quality delivery of study specific needs.

• Ensures the real time collection of information that better informs Country Allocation, Investigator Site Identification through Activation and 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 track plans and actuals.

• Contributes to the selection and management of CROs/Vendors who are responsible for specified tasks/activities/results associated with Study and Site Start Up; periodically assess the performance of the vendors to promote continuous improvement.

• Periodically monitors compliance to process, quality of deliverables and timeliness of Study/Site Start Up related tasks/activities in support of expect deliverables and outcomes; periodically benchmark against the industry and report to collaborators to promote increased efficiencies in achieving Site Start Up at a global, country and site level.

• Identifies, assesses, selects and contributes to the successful implementation of technology solutions that better enable Site Engagement, communications, document exchange, delivery of training and relevant data collection requirements in support of Study/Site Start Up activities.

• Authors, reviews and approves applicable SOPs, Work Instructions and training/educational programs in addition to tracking compliance and/or any deviations to procedures in support of Quality Management Systems; is a designated process steward/owner for the collection, maintenance and oversight of investigator generated documents on a global scale.

• Leads or participates in continuous improvement activities for essential document related tasks/activities/deliverables and associated processes.

• Support any internally sponsored audits as well as any externally scheduled inspections by Regulatory Authorities; contribute to the resolution of cited as result of an audit/inspection.

• Supervises Data Entry/Quality Stewards, EU CTR Managers, Clinical Trials Insurance and Investigator Alert Letter support staff.

• Bachelor’s Degree or higher, preferably in a Life Sciences field; minimum 10 years experience in Clinical Development and preferably, Clinical Operations, including Systems, Study and Site Information Management; minimum 5 years leading direct reports.

• Experience in clinical drug development process and clinical trial planning and execution practices, including Regulatory Authority requirements, IRB/ERC interactions and Investigator Site roles and responsibilities

• Knowledge and understanding of ICH/GCP and regulatory guidelines/directives, especially EU CTD/CTR and ICH E6 R1 and R2

• Experience in managing the use of CTMS for Site Creation & management, TMF for Essential Document Collection and management, the Master Index, Sponsor vs. Country vs. Site requirements

• Knowledge and Understanding of Clinical Trial insurance policies and procedures

• Familiarity in engaging with and overseeing 3rd party service providers (CROs, Labs, etc.)

• Strong and disciplined project management skills; Ability to effectively 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 thoughtfully push-back; Good team player with a positive attitude

• Good communication and social 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/Keynote, Word/Pages, Excel/Numbers, Visio/Lucid Chart, Electronic Document Management Solutions (Veeva, NextDocs, etc.)

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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