17 days old

Clinical Trial Specialist

Alnylam Pharmaceuticals
Cambridge, MA 02139
  • Job Code
    220560

Alnylam (Nasdaq: ALNY) is delivering on a bold vision to turn scientific possibility into reality, with a robust RNA interference (RNAi) therapeutics platform. As the pioneer in RNAi and the leading RNAi therapeutics company, we have always been uncompromisingly dedicated to translating the breakthrough science into transformational medicines to help as many people as possible. Long focused on rare and genetic diseases, our scientific advances are now allowing us to bring the power of RNAi therapeutics to more prevalent diseases and as a result, we are beginning to recognize the full potential of this new class of medicines. Alnylam is committed to its journey to become a top 5 independent, global biopharma company. We are already admired and recognized for our dedication to patients, company culture that empowers people to do their best work, track record of scientific innovation, social responsibility, and commercial excellence.
Founded in 2002, and headquartered in Cambridge, Mass., Alnylam has over 1,650 employees at work across the globe. We are seeking smart, passionate, "change the world" kind of people who are ready to say, "challenge accepted" to our mission. Thanks to the commitment of every employee globally, Alnylam is proud to have been recognized as one of Fast Company's 2021 Best Workplaces for Innovators, a Science Magazine Top Employer three years in a row (2019-2021), a Boston Globe Top Places to Work seven years in a row (2015-2021), a Great Place to Work in Asia, Japan, Brazil, the U.K., Germany, Spain, Netherlands, Italy, France and Switzerland, Seramount's 100 Best Companies (formerly Working Mother 100 Best Companies) and Best Companies for Dads, Bloomberg's Gender Equality Index two years in a row (2021-2022), among others. At Alnylam, we are committed to fostering a diverse, equitable and inclusive work environment, culture, and workforce, and we support several Employee Resource Networks.

Responsibilities
As a member of a global study team, the Clinical Trial Specialist (CTS) is responsible for study
management and monitoring 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.

Summary of Key Responsibilities:

  • Demonstrates study and clinical investigative site management according to Good
  • Clinical Practices, ICH Guidelines, local regulations, and Alnylam SOPs.
  • Creates and provides input into study management requirements and tools, monitoring tools and manuals and training tools.
  • Maintains thorough understanding of current monitoring practices and applicable regulatory requirements and guidelines.
  • Performs study oversight and study site visits to ensure regulatory and study requirements are being fulfilled.
  • Reviews study records including case report forms, consent forms, and other materials, and is versed in remote monitoring approaches.
  • 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.
  • Develops and maintains collaborative relationships with investigational sites study teams, CRO teams, and vendor teams.
  • Produces quality and timely study documentation, including trip reports, tracking and site/sponsor communications in accordance with standard operating procedures.
  • Maintains accurate and timely Sponsor/site communication and correspondence.
  • Responsible for ensuring IMP and supplies accountability.
  • Participates in company, departmental and project team meetings.

Requirements
  • BS/BA degree required; degree in healthcare scientific field preferred.
  • 3 years monitoring / CRO management or CRO oversight experience of clinical trials, including site management, or equivalent.
  • Knowledge of ICH GCP guidelines and the expertise to review and evaluate medical data.
  • Excellent written and verbal communication, problem-solving, and interpersonal skills.
  • Strong attention to detail.
  • Effective organizational and time management skills.
  • Ability to travel up to 35%.
  • Proficient with MS Office Suite (Excel, Word and PowerPoint), familiar with MS Project.
  • Clear alignment with Alnylam's Core Values:
    • Commitment to People
    • Innovation and Discovery
    • Sense of Urgency
    • Open Culture
    • Passion for Excellence
  • If employed in the U.S., being fully vaccinated against COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) is required






Posted: 2022-08-02 Expires: 2022-08-31
Sponsored by:
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Sponsored by:
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Clinical Trial Specialist

Alnylam Pharmaceuticals
Cambridge, MA 02139

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