actm - Shanghai, 中国 - Thermo Fisher Scientific

At Thermo Fisher Scientific, you'll find meaningful work that has a positive impact on a global scale. Join our team in bringing our Mission to life - helping our customers improve the world's health, cleanliness, and safety. We provide our teams with the necessary resources to reach their career goals while advancing science through research, development, and delivery of life-changing therapies. With clinical trials conducted in over 100 countries and ongoing development of innovative frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital, and decentralized clinical trial services. Your commitment to delivering quality and precision will enhance health outcomes that individuals and communities rely on - both now and in the future.

Summarized Purpose:

Responsible for achieving the final clinical deliverable within the specified time frame in the contract with the customer. Analyzes project data and makes informed business decisions with support from expert team members or the line manager. Ensures that all clinical deliverables meet the customer's time, quality, and cost expectations, maintaining profitability by overseeing clinical activities within the contract scope and efficiently managing the clinical team. Typically works on low to moderate complexity projects as part of a team of CTMs.

Key Responsibilities:

• Manages all clinical operational and quality aspects of assigned studies, of low to moderate complexity, in compliance with ICH GCP. May take on Clinical Study Manager (CSM) responsibilities for small and/or less sophisticated projects based on project requirements.
• Develops clinical tools (Supervising Plan, Monitoring Guidelines) alongside the Data Quality Plan, contributing to the development of the Master Action Plan (MAP) for clinical documents. Ensures timely setup, organization, content, and quality of Trial Master File sections. Collaborates in designing CRFs, CRF guidelines, consent templates, and other protocol-related documents. Works with the project manager on client meeting preparation and presentation.
• Collaborates with the clinical team and other departments to meet project deliverables, maintains regular communication with the team, leads team meetings, monitors timelines, resources, interactions, and quality. Implements standardized clinical monitoring processes, ensures timely archiving of documents, and materials.
• Ensures timely delivery of the final clinical output by preparing and supervising activity timelines and metrics, providing updates to the project manager, reviewing projects, implementing recovery actions, managing CRF collection and query resolution, monitoring and co-monitoring trials, and conducting Accompanied Field Visits (AFVs) in smaller regions.
• Communicates with study sites on protocol, patient participation, form completion, and other study-related issues.
• Coordinates project start-up activities, ensures timely ethics committee and regulatory submissions, assesses document quality against Regulatory Compliance Review standards, and follows up on ethics committee queries.
• Provides input on forecast estimates for clinical activities, manages clinical resources, assigns and delegates clinical responsibilities, identifies additional resource needs.

Keys to Success:

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic/vocational qualification. Previous experience demonstrating the knowledge, skills, and abilities to perform the job effectively (minimum 5 years).

Knowledge, Skills, and Abilities:

• Effective leadership, mentoring, training, and team integration skills.
• Strong planning and organization capabilities for workload prioritization.
• Excellent interpersonal and problem-solving skills for multicultural environments.
• Adaptability in changing and ambiguous situations.
• Familiarity with clinical monitoring practices, processes, and requirements.
• Good judgment, decision-making abilities.
• Strong oral and written communication skills, proficiency in English.
• Ability to evaluate workload against project budget and adjust resources accordingly.
• Solid financial acumen, budgeting, forecasting, and fiscal management knowledge.
• Attention to detail, understanding of relevant regulations (ICH/GCP, FDA guidelines, etc.).
• Digital literacy for utilizing automated systems and applications.

Benefits:

We offer competitive compensation, annual bonus plan, healthcare, and various employee benefits. Thermo Fisher Scientific provides employment with an innovative, forward-thinking organization, offering exceptional career and development opportunities. Our company culture values integrity, intensity, involvement, and innovation.

Our Mission at Thermo Fisher Scientific is to empower customers to enhance global health, cleanliness, and safety. Learn about the 5 reasons to join us from our colleagues. With a team of over 100,000 professionals, we share core values - Integrity, Intensity, Innovation, and Involvement - collaborating to advance research, tackle scientific challenges, drive innovation, and support patients in need.