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Lead Clinical Data Management for Global Pharmaceutical Trials
2 months ago
Everest Clinical Research Services Inc. is a leading contract research organization (CRO) providing comprehensive clinical research services to the global pharmaceutical, biotechnology, and medical device industries.
We are renowned for our commitment to quality, exceptional customer service, and flexible solutions tailored to meet our clients' unique needs. Our team of experts works with some of the most prominent companies in the world, contributing to the development of cutting-edge drugs, biologics, and medical devices.
Senior Clinical Data ManagerTo further strengthen our dynamic organization, we are seeking a highly skilled and customer-focused Senior Clinical Data Manager. This role offers the opportunity to lead data management activities for global pharmaceutical trials, ensuring the highest standards of accuracy and integrity.
Responsibilities:- Develop and maintain comprehensive Data Management Project Plans, documenting deviations and resolving issues effectively.
- Serve as the primary point of contact for data management activities, overseeing all deliverables and ensuring timely completion.
- Collaborate with clients to manage expectations, address inquiries, and provide updates on project progress.
- Lead training initiatives for clinical trial personnel on electronic data capture (EDC) systems, dataflow processes, and quality control procedures.
- Mentor and guide junior data management staff, providing support and ensuring adherence to best practices.
- Design and review case report forms (CRFs), develop completion instructions, and generate annotated CRFs for clinical trials.
- Participate in the development and implementation of data management strategies, ensuring compliance with regulatory guidelines and industry standards.
- Manage and archive data management documentation, maintaining meticulous records for assigned clinical trials.
- Bachelor's or Master's degree in health sciences, pharmaceutical sciences, physical/biological sciences, or chemistry.
- Minimum of 5 years of experience in pharmaceutical clinical trial data management, demonstrating a strong understanding of industry best practices and regulatory requirements.
- Proven leadership skills with the ability to effectively manage projects and teams.
- Excellent communication, interpersonal, and problem-solving skills.
