Responsible for the clinical management of one or more assigned clinical trials;
Conducting the day-to-day oversight of the project team and management of the study site(s) related to the responsibilities below:
Managing the preparation of trial specific documents such as project specific plans, templates, and other project specific content;
Managing implementation of study start up and close out activities;
Ensuring that team members are properly trained with regard to the protocol, functional activities, and all study related procedures;
Managing the services delegated and ensuring that the work is performed appropriately by qualified staff, within the timelines agreed;
Ensuring that the study is managed in accordance with GCP and all standard operating procedures and regulations.
Proactively identify critical path activities to ensure successful delivery of program goals and objectives;
Drive clarity and alignment with relevant stakeholders to communicate risks/challenges to drive progress and ensure appropriate prioritization;
Support preparation efforts for governance;
Responsible to facilitate execution of assigned programs from late discovery/preclinical/Pre-IND planning through program exit utilizing clinical management/project management tools and processes to maintain strategic direction, project schedule/timeline, communications, budget/cost and to identify and mitigate risks;
Provide leadership in Program Team meetings to ensure timely progress and proactive identification of potential issues or obstacles and achieves resolution or plans contingencies. Follow issues through to resolution ensuring that all key stakeholders are informed of outcomes and program implications;
Foster strong relationships and support effective and impactful communications with management, team members and functional line managers, as well as external partners and clients in order to ensure active management of issues/risks/decisions/opportunities.
Fluent in English;
Bachelor’s degree + minimum 3 years clinical research/clinical management experience;
Thorough knowledge of ICH GCP, ANSM experience helpful;