Clinical Team Manager FSP - Country Study Manager

Thermo Fisher ScientificRemote, BelgiumremoteSalary not postedView the original posting at Thermo Fisher Scientific ↗

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description The Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. The Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. The position involves working on projects of low to moderate complexity and as part of a team of CTMs. − Works in an environment that is constantly evolving with new processes and systems, internally and externally and the CSM needs to be able to adapt to these changes quickly and efficiently. Flexible and resilient with ability to evolve in changing and challenging environment. − Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives. − Demonstrates an excellent understanding of the clinical study, drug development, sample management and other associated processes and quality requirements. − Strong project management mindset and demonstrated ability to work and lead in a matrix team environment involving both internal (client) and external partners. − Able to represent client to external physician investigators and other external clinical site staff, institutional review boards, etc., including the ability to answer complex questions − Able to work effectively within the local environment and collaborate extensively with geographically distant central team members. Ability to work effectively in a remote environment. − Able to set and manage priorities and performance targets in a local environment. − Effectively plans, communicates, coordinates and facilitates delivery of team objectives. − Solid understanding of country local regulations, ICH-GCP guidelines and client written standards. − Available and willing to travel for project related activities as required (e.g. Investigator & Monitors Meeting attendance. − Acts as role model in line with client core values and behaviors. − Able to understand the impact of technology on studies and to use/develop computer skills while making appropriate use of client systems/software. − Demonstrates conceptual, analytical and strategic thinking. − Effective at problem solving and conflict resolution. − Demonstrates good English language written and verbal communication skills in addition to proven negotiation skills. − Flexible with high learning agility. − Strong computer skills Role Description: The Country Study Manager (CSM) is pivotal to trial delivery and compound development for the global R&D organization, providing leadership and driving decisions related to the conduct of a clinical trial. The CSM leads and manages the operational implementation of country feasibility, planning and delivery of R&D Pharma Phase I-IV clinical studies within and across therapeutic areas. The CSM serves as the operational point-of-contact between the Central Study Team and in-country staff aligned to the study. Accountable for high quality execution/delivery of studies within country as defined by the protocol & per agreed timelines / budget; overall project management of study activities. − With limited oversight: • May provide input into the study concept, protocol, logistics and may co-ordinate other expert local input • Assess appropriateness of study for local environment. • Conducts country/site feasibility. • Leads selection of sites within country; accountable for site performance. • Ensures development and maintenance of country study plan and forecast, including budgets, resource estimates, mileston

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