Country Trial Manager Job at Thermo Fisher Scientific

Thermo Fisher Scientific is hiring for the role of Country Trial Manager!

Responsibilities of the Candidate:

• Acts as the lead study reference, for assigned projects which are typically of moderate to high complexity, providing global, territorial, and site-level oversight and leadership and managing local clinical operational and quality aspects in compliance with company quality framework, ICH GCP, and international standards throughout the entire life cycle from initiation to close-out.
•  Depends on the study model, coordinates start-up activities, or works in collaboration with the global start-up team.
• Facilitates successful site qualification visits and site initiation visits as well as timely ethics committee and regulatory submissions (if appropriate).
• Reviews and follows up on all questions raised by the ethics committees. Ensures potential rate-limiting factors (e.g. drug supply, vendors) are identified and managed to ensure maximum and seamless recruitment.
• Continuously measures and assesses study performance by collecting and analyzing study metrics to determine where the study stands and to predict future status and progress with the overall goal of ensuring that contractual obligations are met (or organizing contract amendments as necessary).
• Regularly reviews projects using tracking and management tools, provides status updates to the O&SS Lead, identifies risks and implements proactive solutions and recovery actions, identifies problems, and escalates appropriately and in a timely manner.
• Works with project stakeholders to create the study's recruitment strategy, plans, and forecasts to ensure the project is completed as per the contract and timelines.
• Monitors and analyzes recruitment methods against results in collaboration with GEO and pre-identification, processing, and retention of patients at sites against Accelerated Enrollment Solutions is a business unit of Pharmaceutical Product Development, LLC, a Delaware limited liability company (“PPD”), collectively made up of Acurian, Inc. and Synexus, each a subsidiary of PPD. target to ensure a strong study funnel and to help implement changes to the strategy during the study and at close, with feedback to appropriate departments to ensure future learning.

Requirements:

• Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
• Good planning and organizational skills to enable effective prioritization of workload
• Solid interpersonal and problem-solving skills to enable working in a multicultural matrix organization
• Capable of working effectively in a changing environment with complex/ambiguous situations
• Familiarity with the practices, processes, and requirements of clinical research
• Good judgment and decision-making skills
• Effective oral and written communication skills, including English language proficiency
• Capable of evaluating workload against project budget and adjusting resources accordingly
•  Knowledge of budgeting, forecasting, and fiscal management
• Strong attention to detail
• Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
• Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.