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 document 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:

o   Fiercely Innovative

o   Open Culture

o   Purposeful Urgency

o   Open Culture

o   Passion for Excellence

o   Commitment to People