Clinical Trial Operations Manager

Cambridge, MA

Contract

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OVERVIEW

The role of the Clinical Trial Operations Manager will be to participate in the implementation of key organizational process improvement initiatives. This role will be responsible for serving as clinical trial leader for a large-scale multi-country trial (Phases II-IV). They will also be responsible for protocol preparation, generation of manuals for trial support committees and other trial documentation and lead the multi-disciplinary team responsible for study completion.  The role is located in Cambridge Massachusetts. 
 
RESPONSIBILITIES

  • Participates in the implementation of key organizational process improvement initiatives. 
  • Serves as clinical trial leader for a large-scale multi-country trial (Phases II-IV). Responsible for protocol preparation, generation of manuals for trial support committees and other trial documentation. 
  • Leads the multi-disciplinary team responsible for study completion.

EXPERIENCE

  • 7 years of experience in pharmaceutical industry or clinical-related discipline including at least 5 years clinical research experience, including 2 years of trial operations management.

EDUCATION

  • Bachelor's degree (advanced degree preferred)

To be a best-fit your strengths must include

  • Interact effectively with scientists and managers within and outside Trial Operations Department. 
  • Strong interpersonal and communication skills (verbal and written).
  • Ability to handle multiple tasks and to prioritize, strong organizational and presentation skills.
  • Ability to work autonomously and to efficiently and effectively provide status reports.
  • Ability to anticipate and timely escalate issues and to define appropriate action plans. 
  • Knowledge and qualification with international standards (e.g. GCP, CDISC, etc.), company tools. (including data management systems), processes and SOPs. 
  • Experience in managing and leading international meetings (Clinical Trial Team, expert meeting, etc.). Ability to work in an international environment with internal and/or external partners.
  • Strong English skills (verbal and written if English is the second language.)
  • Knowledge of industry data management standards and practices.

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

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