Manager, CDM
2 weeks ago
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Summary of Responsibilities:
• Based on forecast models, manage the resources to meet or exceed business Service Level Agreements.
• Supervise, Mentor, Evaluate and aid in staff development, career development, people skills and achievement of competency standards.
• Oversee EDC User account activations, deactivations and modifications, Data Entry activities, De Commissioning activities, eTMF documentation tasks.
• Maintain productivity and quality indicators for global staff and Support recruitment of new potential candidates.
• Participate in identification and implementation of solutions to local and regional data management issues and concerns, including initiative-taking prevention strategies based on metrics and forecasts.
• Assist with the quality management activities according to the Global data management
• Plans and Quality Management (QM) Plans and in process quality control activities to ensure staff deliver accurate, timely, consistent, and quality clinical data.
• Support locally based project staff on achieving client satisfaction (internal and external) through delivery of quality data, on-time, and on-budget.
• Assist with development and execution of training programs and ensure staff achievement of position competencies.
• Support development of global, harmonized SOPs and specific quality processes and procedures for user Account Management/Data Entry activities/ eTMF Documentation/ Decommissioning.
• Identify and implement process improvement solutions and ensure revenue and operating margin performance of the group to agreed targets.
• Create action plans to address staff quality and performance issues identified by clients, via client satisfaction surveys, and/or from core project team feedback.
• Manage utilization and billability of staff, planning for resource allocation, recruitment based on individual skills, competencies and availability and Provide support to Business Development for time and cost estimates.
• Ensure that staff reviews (performance review, training, and development, etc.) are completed for each member in accordance with Fortrea guidelines.
• All other duties as needed or assigned.
Qualifications (Minimum Required):
• B.Sc. degree in Life Science/Pharmacy or equivalent/related discipline or certification in a related allied health profession from an appropriately accredited institution (e.g., Nursing certification, Medical or Laboratory Technology) is preferred.
Experience (Minimum Required):
• Eight to ten (8-10) years of relevant work experience with two to four (2-4) years supervisory experience to include User Account Management/Data Entry activities/ eTMF Documentation/management and knowledge of several therapeutic areas.
• Demonstrated skill for management of staff of 10 to 15 employees within one location of a region (Asia Pac, Europe, North America, etc.).
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
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