Director Registry

Why Wait? Our passion is unmistakable! Have you ever wished you could be as excited about your career as you once were? Or wanted to take your career to the next level without needing to leave your organization for professional growth? Welcome to Covance.



As a billion dollar company with widespread global reach, Covance's ability to offer integrated drug development services is unsurpassed. Our employees are passionate about delivering excellent customer service and unfaltering science. If you are looking to re-energize your career, Covance is the place to be.



Interact with prospective clients to develop prospective study solutions and to provide insight into registry program opportunities and application

Design and implement registry solutions in support of awarded projects

Promote Covance's expertise in the market through authored material and speaking engagements

Promote registry solutions as a crucial component of strategic, integrated risk management program planning

Deliver ongoing oversight and support to projects with a registry component including resource planning and oversight; team supervision, client communication and reporting, financial management and reporting

Provide training and mentoring support to Periapproval operational staff; implement formal Registry training for Project Management, Business Development and other staff as needed

Keep abreast of all industry regulatory changes and requirements related to registry implementation and development

Qualifications

Demonstrated ability to design and develop registry solutions suitable for capturing clinical data in clinical trial or observational study setting

Deep understanding of applicable regulations including ICH, CFR, GCDMP, HIPAA, and patient privacy restrictions worldwide.

Understanding of the system validation and user testing requirements

Familiarity with Electronic Health Record Technology

Proven capability to lead and implement registry solutions in actual practice setting

Up to date knowledge of FDA and EMEA guidances with regard to patient risk management and pregnancy registries

Understanding of structural and functional aspects of registries within a variety of contexts including post-licensure safety surveillance, risk management, and post-licensure effectiveness assessment

Understanding of Post-Marketing Commitment (PMC) registry design and implementation (including IND reporting requirements) as well as non-IND registry design and implementation

PharmD, PhD, DrPH, MPH with 10+ years of, working in Regulatory agencies, academics, investigations and/or related industry experience





At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. Covance is well-positioned for continued growth!


Click here to learn more about