Senior Site Start-Up and Regulatory Specialist is responsible for providing delivery and expertise in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, and review and finalization of essential documents required for site initiation. May act as main contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs).
Position provides customer-focused leadership in the execution of the start up of sites in one or multiple Phase II through Phase IV clinical trials across all functional Site Start-Up (SSU) areas.
Provides customer-focused leadership in the execution of the start up of sites in one or multiple Phase II through Phase IV clinical trials across all functional Site Start-Up (SSU) areas. Accountable for the delivery of activation-ready study sites on time, on budget, and in compliance with all applicable regulations.
Provides customer-focused leadership in the execution of the start up of sites in one or multiple Phase II through Phase IV clinical trials across all functional Site Start-Up (SSU) areas. Accountable for the delivery of activation-ready study sites on time, on budget, and in compliance with all applicable regulations.
Assists senior managers in managing work and teams within a specific or broad area of site start-up, such as site activation, regulatory, submissions, site contracts, or regulatory records. Ensures fulfillment of customer requirements and compliance with related regulations.
This is an exciting role with one of the industry leading CROs. This is an office-based role in London. This role is for someone with healthy experience in Clinical Research that has a strong interest in submissions and feasibilities. You will have an experienced background in Regulatory Affairs, Clinical Research or Study Start-Up.
This is an exciting role with one of the industry leading CROs. This is an office-based role in London. This role is for someone with healthy experience in Clinical Research that has a strong interest in submissions and feasibilities. You will have an experienced background in Clinical Research or Study Start-Up.
BENEFITS - Generous Salary - Full Benefits Package (Pension Scheme, Private Healthcare, Life Assurance etc.)
This is an excellent opportunity to join one of the world's leading CROs as a Start-Up Specialist. The Start-Up Specialist manages the start-up of investigator sites in all phases of clinical trials. This position can be at varying levels depending on the experience of the candidate. There are Start-Up Specialist I, II and Senior level positions available.
You will be involved in study start-up, site initiation, site monitoring and close out visits on assigned studies across multiple therapy areas. You will implement and monitor trials across a wide spectrum of therapeutic areas (phase I-IV), ensuring that client and investigator obligations are met, and overseeing compliance with ICH GCP and European regulatory requirements. You will carry out monitoring visits including initiation, routine monitoring and close out.
You will be involved in study start-up, site initiation, site monitoring and close out visits on assigned studies across multiple therapy areas. You will implement and monitor trials across a wide spectrum of therapeutic areas (phase I-IV), ensuring that client and investigator obligations are met, and overseeing compliance with ICH GCP and European regulatory requirements.
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