Clinical Trial Specialist
Company: Alnylam Pharmaceuticals
Location: Cambridge
Posted on: April 16, 2024
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Job Description:
Work_Category - hybridDescription 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 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
About Alnylam
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.
Keywords: Alnylam Pharmaceuticals, Waltham , Clinical Trial Specialist, Healthcare , Cambridge, Massachusetts
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