Local Clinical Trial Manager

🔥 0 minutes ago

🇩🇰 Denmark – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 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.

📋 Description

• Accountable for achieving final clinical deliverables within contracted timelines • Lead the local study team and manage study activities within Denmark and other assigned countries • Serve as the operational point of contact between central and in-country study teams • Conduct study feasibility, site selection, and oversee local study performance • Deliver studies on time, within budget, and to quality expectations under applicable regulations and guidelines • Develop and maintain country study plans, budgets, resource estimates, milestones, timelines, and risk plans • Troubleshoot and resolve study-team issues and ensure site supplies and inventory • Maintain accurate study systems and trial master files and report progress to stakeholders • Monitor risk and performance indicators and review study databases for accuracy • Review and approve monitoring visit reports and ensure monitoring activities are completed • Manage local vendors, contracts, payments, communications, and issue resolution • Develop study documents, plans, manuals, informed consent forms, and regulatory submissions • Maintain communication with regulatory authorities and ethics committees • Support audits, inspections, regulatory compliance, and corrective follow-up • Coordinate training, investigator meetings, monitor meetings, and local study meetings • Manage safety issues and safety report handling, including SAE reporting • Collaborate with medical, legal, finance, regulatory, vendor, site, and external investigator stakeholders • Participate in end-of-study learning debriefs and identify process improvements • Travel as needed for the role

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 3+ years of comparable experience • Experience in site monitoring • Knowledge of clinical study, drug development, sample management, and associated processes and quality requirements • Strong project management skills and ability to work and lead in a matrix team environment • Understanding of country local regulations and, if required, other countries' regulations, ICH-GCP guidelines, and written standards • Strong English written and verbal communication skills • Negotiation skills • Strong computer skills and ability to learn new or evolving computer systems • Ability to work effectively in a remote environment • Willingness and availability to travel for project-related activities • Ability to understand and apply digital innovations to clinical trials • Conceptual, analytical, strategic thinking, and data literacy • Problem-solving and conflict resolution skills • Flexibility, resilience, and high learning agility

🏖️ Benefits

• Health and wellbeing support • Accessibility services and accommodations for job seekers with disabilities • Equal employment opportunity and affirmative action employer • Remote work arrangement

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