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Clinical Trial Manager

🔥 1 minute ago

🌲 North Carolina – Remote

infoinfo

⏰ Full Time

🟡 Mid-level

đźź  Senior

đź§Ş Clinical Research

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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.

đź“‹ Description

• Manage clinical operational and quality aspects of allocated low- to moderate-complexity studies in compliance with ICH GCP • Develop clinical tools and contribute to Data Quality Plans, Master Action Plans, Trial Master File organization, CRFs, informed consent templates, and protocol-specific documents • Collaborate with project managers, clinical teams, and other departments to prepare and present client meetings • Lead team meetings and maintain timelines, resources, interactions, and quality • Implement and train teams on standardized clinical monitoring processes • Ensure timely archiving of study documents and materials • Achieve final clinical deliverables within contractual timelines by monitoring clinical activity timelines and metrics, reviewing tracking tools and monitoring visit reports, implementing recovery actions, and managing CRF collection and query resolution • Monitor or co-monitor clinical trials and assess performance against contractual obligations • Communicate with study sites regarding protocol, patient participation, CRF completion, and other study issues • Coordinate study start-up activities and ethics committee and regulatory submissions • Ensure essential document quality and follow up on ethics committee questions • Provide input to clinical activity forecasts and manage clinical resources, delegation, and additional resource requirements

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 5+ years of previous experience providing the knowledge, skills, and abilities to perform the job • Equivalency may consist of a combination of appropriate education, training and/or directly related experience • Leadership, mentoring, training, team motivation, and integration skills • Planning and organizational skills for workload prioritization • Interpersonal and problem-solving skills in a multicultural matrix organization • Ability to work effectively in changing environments with complex/ambiguous situations • Familiarity with clinical monitoring practices, processes, and requirements • Judgment and decision-making skills • Effective oral and written communication skills, including English language proficiency • Ability to evaluate workload against project budgets and adjust resources • Financial acumen and knowledge of budgeting, forecasting, and fiscal management • Strong attention to detail • Understanding of relevant regulations, including ICH/GCP and FDA guidelines • Computer skills using Outlook, Excel, Word, and other automated systems and computerized applications • Frequent domestic and international travel and driving to site locations

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Passion, innovation, and commitment to scientific excellence

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