Site Activation Lead

Role Summary

CON Study Start-up Services are building for a bright future. Site activation is currently one of the most challenging aspects within the project lifecycle. Due to the fast nature of the business Study Start Up works within, we're looking to develop our team to reach for new frontiers of performance and quality. You will be responsible for the coordination and lead of the country Study Start Up teams for multicountry studies; Driving the teams' efficiency and adherence to study procedures and timelines; Establishing regulatory requirements and site contracts to ensure a smooth start-up process; Liaising and coordinating with Project Manager to facilitate consistent communication for Start up. The Site Activation Lead be the team motivator for the Study Start Up team.

Role

• You will be required to participate in Sales preparation and attend client meetings and bid defense
• Participation in executing Global/Regional SSU initiatives
• Understand client objectives and be accountable for the development, implementation and execution of the Study Start Up Strategy from site identification (PSV) to SIV in all countries across assigned region.
• Serve as the primary contact with the Sponsor, PM other Function Leads and Third Parties who have an impact on Study Start Up. Work with key stakeholders to optimize performance and collaborate to ensure successful study outcomes.
• Responsible for all Study Start Up activities in accordance with agreed budgeted hours, manage and escalate any significant variation to study budgets.
• Responsible for the provision of Study Start Up metrics for assigned studies.
• Attend study related meetings and calls for all assigned studies

Experience and Qualification

• Preferably with a degree in Life Sciences, you will have previous submissions/dossier experience within clinical studies for either a CRO or Pharmaceutical company.
• Minimum of 7 Years of experience in a clinical trial lead environment, preferably with Study Start Up project management experience
• Knowledge and experience in the clinical study start up requirements and activities for all assigned countries (or the ability to find this out for new countries)
• Good organizational skills and the ability to manage multiple tasks
• Meticulous attention to detail
• Good written and verbal communication skills. Proficient in English and language required for country assignments
• Highly developed problem solving skills
• Strong people management and effective communication skills
• Strong project management skills
• Customer service focused
• Competent computer skills