Field Clinical Manager
Kuala Lumpur, Malaysia · onsite
Salary not posted
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Sr Feasibility Site Specialist Job Description Join Us as a Sr Feasibility Site Specialist - Make an Impact at the Forefront of Innovation The Sr Feasibility Site Specialist develops the critical path for site activation within assigned projects to provide consultation, guidance and support for rapid site activations. Purpose: Represents Thermo Fisher Scientific in the global medical research community and is the main point of contact for potential investigative sites. Provides strategic review in feasibility planning and execution and ensures sites receive support and issue resolution throughout the feasibility process. Using local knowledge, company systems, external sources and sponsor input, create, reviews and recommends site lists and conducts pre-award outreach suitable for study needs. Serves as a subject matter expert to cross-functional teams, mentors junior team members and contributes to continuous process improvement initiatives. Performs administrative and analytical tasks supporting the investigator database, site identification, site list development and rapid site start-up deliverables. Create, reviews, validates, and recommends site lists in applicable clinical systems and performs quality control and risk monitoring to mitigate risk and support data quality in local and global investigator databases. Depending on business needs, regional operating models and organizational requirements, the Senior Feasibility Site Specialist may perform different combinations of these responsibilities while contributing to feasibility objectives. Reports to Clinical Operations People Manager. Major Job Responsibilities Gathers feasibility data and performs local site list vetting and pre-award site outreach, using approved internal tools and external sources to ensure the site list is specific to the assigned study indication. When acting as Global Feasibility Coordinator, validate the initial draft potential site list created by country FSS teams, by reviewing approved data in collaboration with feasibility managers, project and local teams for assigned studies or customers; ensures agreed Service Level Agreement timelines and metrics are met across the specified region or regions. Appointment as coordinator depends on utilization capacity and the skills required to coordinate global data. Uses site-profile data and execution outcomes and provides analysis on site suitability, country strategy, risk, capacity, start-up assumptions, bid-defense and pre-award phases. May administer, prioritize and resource the site-list development and list-loading process and collaborate with other departments to support rapid site start-up. Ensures site and database contact and account information is current. Liaises with other departments, including Legal and Quality, to manage investigators with medical-license concerns or disciplinary actions, FDA or Regulatory restrictions, ISD disclosures, privacy issues and quality-of-performance concerns; ensures regulatory processes and due-diligence checks are conducted, documented, filed and escalated as necessary in an expedited manner. Reviews Confidential Disclosure Agreements (CDAs) and site survey data for accuracy, completeness and consistency; follows up with investigative sites to resolve discrepancies or missing information. Coordinates and manages feasibility site-document collection and tracking to support study milestones and deliverables, ensuring timely completion, data accuracy and adherence to quality and compliance requirements. May conduct phone interviews with physicians and other site personnel to discuss standard of care and obtain protocol-level input; where applicable, conducts onsite feasibility visits. May support or participate in client calls and address study-specific client requirements related to site-feasibility communications at the direction of functional leadership or the People Manag
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Kuala Lumpur, Malaysia · onsite
Salary not posted
United States, Remote · remote
Salary not posted
United States, Remote · remote
Salary not posted