Job Description - Clinical Trial Specialist (230796) Overview
As a member of a global study team, the Clinical Trial Specialist (CTS) is responsible for assisting with study management of assigned projects in accordance with Alnylam SOPs, Good Clinical Practice, International Conference on Harmonisation (ICH) Harmonised Tripartite Guidelines, local regulations and additional sponsor requirements. The CTS will participate in company, departmental and project team meetings. This position reports into Clinical Operations.
Key Responsibilities
Assists Clinical Trial Manager(s) with study, CRO and clinical investigative site management according to Good Clinical Practices, ICH Guidelines, local regulations, and Alnylam SOPs. Creates and / or provides input into study management tools, monitoring tools and study manuals and training materials. Maintains thorough understanding of applicable regulatory requirements and guidelines. Serves as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols. Provides input, tracks progress, and works to implement corrective action plans for study and individual site recruitment and retention plans. Maintains accurate and timely Sponsor/site communication and correspondence. Responsible for ensuring IMP and supplies accountability. Plans and documents Clinical Trial Working Group meetings for assigned program(s). Add appropriate documents to the TMF and perform necessary quality reviews of the TMF. Participates in company, departmental and project team meetings. Qualifications
BS/BA degree required; degree in healthcare scientific field preferred. 1 – 2 years monitoring / CRO management or CRO oversight experience of clinical trials, including site management, or equivalent. Knowledge of ICH GCP guidelines. Excellent written and verbal communication, problem-solving, and interpersonal skills. Strong attention to detail. Effective organizational and time management skills. Ability to collaborate with internal personnel, site and CRO staff. Proficient with MS Office Suite (Excel, Word and PowerPoint), familiar with MS Project. Clear alignment with Alnylam's Core Values: Fiercely Innovative Open Culture Purposeful Urgency Passion for Excellence Commitment to People About Alnylam
Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.
Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2022, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2023 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.
Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law. Alnylam is an E-Verify employer.
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