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Precision for Medicine is seeking a (Senior) Regulatory and Start Up Specialist to join their team in France. This role is crucial for ensuring the timely and quality delivery of site activation readiness. The role can be fully remote.Responsibilities:
- Delivery of site activation readiness.
- Maintenance of project plans and trackers.
- Communication with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management.
- Act as Subject Matter Expert for site level critical path to Site Activation data points.
- Support negotiation of study budgets and the execution of investigator contracts.
- Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent.
- 1 year or more as a Regulatory/ SU specialist in a CRO or pharmaceutical/ biotech industry or equivalent.
- Experience drafting, reviewing and negotiating agreements related to clinical research.
- Experience developing and negotiating budgets.
- Strong communication and organizational skills.
- Fluency in French and English.
- Opportunity to impact positive change for the company.
- Remote work opportunity.
Precision Medicine Group
Precision Medicine Group is a specialized company operating in the financial and operational aspects of project management, particularly within the Clinical Research Organization (CRO) industry. They excel in managing and coordinating change orders, working closely with project management, financial analysts, and functional leads. Their expertise lies in providing detailed variance analysis, budgeting, financial forecasting, and maintaining meticulous financial records. They ensure regulatory compliance and adapt to evolving project requirements. The company emphasizes accuracy, strategic communication, and collaboration with both internal teams and external stakeholders.