The Manager, Start-up Operations is accountable for delivering on-time, high quality study start-up and maintenance activities within a country, or country cluster, as well as for central/local IEC/IRB submission, document collection, update of relevant systems and filing. This role will lead a start-up team within a country or a cluster of countries that will work to activate study sites and ensure the filing of documentation into the eTMF system and completion of CTMS from the start to the end of the start-up period, including maintenance throughout the cycle of the study. The Manager, Start-up Operations will also have direct line management responsibility for the start-up operations team in their country or a cluster of countries and oversight of all country-level client deliverables and timelines of start-up at the country and site levels. The Manager, Start-up Operations will act as a local point of contact for activities around start-up deliverables in the country. The Manager, Start-up Operations will have operational detailed oversight, ensuring right commitments and right timelines are met. The Manager, Start-up Operations will be the first line of escalation for performance issues and quality concerns and will have the necessary overview to confirm country start-up stays on track. This role will serve as the local Subject Matter Experts (SME) for start-up processes including timelines, training and development of the start-up team at the local level and on local regulations
Level of education preferred (if required or experience level which may be substituted for level of education).
Professional degree/designations/certifications/licenses legally required (i.e. RN, MD, VDM etc.).
* More than 5 years of experience in clinical development or regulatory process.
* In depth experience of applying strong knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines. Expert knowledge of investigator start-up documents; previous interaction with operational project teams and investigative sites.
* In depth experience of issue escalation and resolution.
* Credible role model in effective communication and problem solving.
* Proven strengths managing relationships and negotiating solutions while maintaining a level of approachability with colleagues both internal and external to the organization.
Relevant supervisory experience