
10,000+ employees
Founded 1956
đĽ Healthcare
đŚ Logistics
đ Manufacturing
Healthcare ⢠Logistics ⢠Manufacturing
Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.
đĽ 12 hours ago
đ¸đŞ Sweden â Remote
â° Full Time
đĄ Mid-level
đ Senior
⨠Clinical Trial Coordinator
đť Ghost score 10%
đŁď¸đ¸đŞ Swedish Required
đŁď¸đŠđ° Danish Required
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10,000+ employees
Founded 1956
đĽ Healthcare
đŚ Logistics
đ Manufacturing
Healthcare ⢠Logistics ⢠Manufacturing
Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.
⢠Coordinate, oversee, and complete assigned trial activities according to the task matrix ⢠Perform department, internal, country, and investigator file reviews and document findings ⢠Ensure allocated tasks are completed on time, within budget, and to a high-quality standard ⢠Communicate project risks proactively to project leads ⢠Provide system support for Activate and eTMF and keep system databases current ⢠Process documents sent to the client eTMF, perform eTMF reviews, distribute mailings and communications, and provide documents and reports to internal teams ⢠Analyze and reconcile study metrics and findings reports ⢠Assist with Investigator Site File and Pharmacy binder materials and non-clinical study supplies ⢠Support translation materials and translation quality control ⢠Maintain knowledge of SOPs, client directives, and regulatory guidelines ⢠Conduct on-site feasibility visits where applicable for Asia Pacific roles ⢠Support client and internal meeting scheduling ⢠Review and track local regulatory documents ⢠Support risk-based monitoring activities ⢠Maintain study documentation and systems, including team lists, training requirements, system access, and activity plans ⢠Transmit documents to clients and centralized IRB/IEC ⢠Maintain vendor trackers ⢠Support regulatory submissions ⢠Obtain site-selection documents directly from sites ⢠Assist with regulatory compliance review packages ⢠Coordinate with internal departments to align site start-up activities with the site activation critical path ⢠Complete Site Interest Plans in CTMS and collect associated documents where applicable ⢠Document communications, follow-ups, and survey responses in real time ⢠Review survey data for logical, complete, and relevant responses ⢠Collaborate with teammates and clinical personnel regarding site issues and risks ⢠Ensure efficient site contact and follow-up plans and escalate non-compliance ⢠Act as a local expert on site capacity and experience and recommend additional sites ⢠Liaise with Global Investigator Services to resolve investigator queries and maintain account and contact information ⢠Contribute to global feasibility processes and best practices ⢠Train new personnel in processes and systems ⢠Use local knowledge to identify and develop new sites
⢠High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification ⢠Bachelor's degree preferred ⢠Previous experience comparable to 0 to 1 year ⢠Equivalency through a combination of appropriate education, training and/or directly related experience may be considered ⢠Ability to work in a team or independently ⢠Good organizational skills and strong attention to detail ⢠Ability to handle multiple tasks efficiently and effectively ⢠Ability to analyze project-specific data/systems ⢠Strong customer focus ⢠Flexibility to reprioritize workload ⢠Working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs ⢠Good English language and grammar skills ⢠Proficient local language skills in Swedish or Danish ⢠Proficient in MS Office (Word, Excel, and PowerPoint) ⢠Ability to learn and master clinical trial database systems ⢠Ability to successfully complete the organization's clinical training program ⢠Effective oral and written communication skills ⢠Essential judgment and decision-making skills ⢠Ability to accurately follow project work instructions ⢠Good negotiation skills ⢠Ability to manage risk and perform risk escalation appropriately
⢠Fully remote work setting if located outside Copenhagen or Stockholm ⢠Hybrid work if located in Copenhagen or Stockholm ⢠Standard Monday-Friday work schedule
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