ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device, and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Trial Manager in FSE The Trial Manager (TM) manages assigned clinical trials, leads the FSE trial teams to ensure high-quality execution of the trials and deliverables within all countries in the FSE. The TM enables the Adjacent Affiliate teams to deliver clinical trials in the shortest possible time in accordance with Client policies and procedures, SOPs, local legislation, and GCP requirements.
Responsibilities Overall project management of assigned clinical trials in the FSE and adjacent affiliates.
Responsible for deliverables and high-quality execution of clinical trials in the FSE and adjacent affiliates.
Leading the FSE trial teams.
Planning, executing, coordinating tasks, and communicating between relevant roles, such as FSE CTA and CRAs in adjacent affiliates and global trial management, to facilitate the progress of the trial.
Attending all trial-related meetings/TCs and ensuring knowledge sharing across the FSE trial team.
Proactive risk identification and executing mitigation plans at the FSE level and adjacent affiliates.
Ensuring successful start-up of clinical activities in the FSE and adjacent affiliates (all trial-related documents review, CTA dossier oversight, ensure timely HA/EC submission/approval).
Responsible for trial budgets (ClinCost): preparation and tracking in the FSE and adjacent affiliates.
Execute and follow up on Recruitment and Retention plans at the FSE level and adjacent affiliates.
Perform Visit Report review (all types of visits).
Conduct co-monitoring visits across the FSE.
CTMS set-up & update at country level (for adjacent affiliates).
Oversight and compliance check of STMF (nD/Veeva) for assigned clinical trials in close collaboration.
Supervise clinical supplies' processes in the FSE and adjacent affiliates, e.g. ordering, handling ancillary, import-export process.
Report timely on quality issues.
Audit readiness, audit action plans, and follow up for assigned clinical trials in FSE.
Inspection readiness and inspection action plan for assigned clinical trials in FSE.
Knowledge and Experience Working knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP), and applicable international regulations and guidelines.
Clinical Development process and procedures.
Project planning experience including oversight of study deliverables, budgets, and timelines.
Experience anticipating and resolving problems.
Experience writing and presenting clearly on scientific and clinical issues.
Experience collaborating and leading cross-functional teams (team/matrix environment).
Knowledge of project risk management assessment and mitigation approaches.
Proven experience of successful collaboration in a multi-national environment.
Proven decision-making and problem-solving capabilities.
Key Competencies Project Management
Risk assessment
Critical Thinking and Planning
Matrix Team organization/leadership
Metrics analysis
Written and oral communication
Delivery focus
Relationship management
Conflict resolution
Adaptability and Flexibility
Working in virtual teams
Ability to work in a changing environment to be agile and proactively finding efficient ways of doing things
Excellent communication skills - ability to communicate and build relationships with various stakeholders
Team-oriented personality with a high degree of flexibility and cross-cultural awareness
Presentation and negotiation skills
Education Requirements BA/BS/BSc or RN, with Master level of education preferred.
Fluency in English - written and spoken.
Minimum 5 years of experience in operational aspects of planning and conducting clinical trials.
Minimum 1 year (preferably 2 years) of experience in project management of clinical trials at the regional level (e.g. multi-country set-up).
Benefits of Working in ICON Our success depends on the knowledge, capabilities, and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development. At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best-in-class employee benefits.
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