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. Conducting operations in ~100 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.
• 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.
• 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.
• In lieu of the above requirement, approximately 18 months of relevant experience in related field (pharmaceutical, laboratory, data analysis) incorporating approximately one year clinical data management experience in addition to the five-year relevant experience in
• User Account Management/Data Entry activities/ eTMF Documentation will be considered.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Broad knowledge of drug development process will be considered.
• Understanding of global clinical development budgets and relationship to productivity targets.
• Knowledge of resource management system/processes.
• Knowledge of time and cost estimate development and pricing strategies.
• Thorough knowledge of ICH/GCP Guidelines including international requirements for the conduct of clinical development programs especially as related to data handling and processing.
  
  

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.).
• Excellent oral and communication and strong presentation skills.
  
  

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. For more information about Fortrea, visit www.fortrea.com.

Fortrea Is Proud To Be An Equal Opportunity Employer

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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