Clinical Research Manager

  • 21st Floor, Otemachi Financial City North Tower,, Tokyo, 1-9-5 Otemachi, Chiyoda-ku,, Japan
  • Full-time

Company Description

Citeline Engage, Informa Pharma Intelligence

As an integral part of Informa Pharma Intelligence, Citeline Engage provides targeted support to enhance study planning, design, feasibility, and trial awareness.  Our robust global network of healthcare providers spans multiple therapeutic areas with real-world patient data enhancing identification and targeting strategies.  Our in-house Clinical Research Managers (CRM) work hand-in-hand with the client to scope an ongoing or future clinical trial, develop and execute an outreach strategy and relay critical project updates in a manner that best suits the unique needs of the client.

Informa Pharma Intelligence is the trusted partner of all of the top 50 global pharmaceutical companies and the top 10 contract research organizations – providing timely intelligence and insight to make authoritative decisions.  Our connected team of clinicians, researchers and analysts are based in key markets around the globe.  Drawing on a foundation of high quality proprietary data, the client can trust that the insights gained through our solutions have the level of precision needed to make forward focused decisions with confidence and ensure clinical trial success.

Role

Citeline Engage is seeking a CRM to join the team.  You will work on the execution and management of Citeline Engage clinical trial projects, including operational reporting, collaboration with client solutions, operations, product management, marketing, and analytics.

This includes project management and ongoing operational support of key clinical trial innovation associated with the integration and ongoing execution of the Citeline Engage initiatives.

As a CRM, you will provide cross-functional support to current workflow and future operational growth required for greater efficiencies and commercialization for product execution.  You will have expertise at defining the optimal site profile for a clinical trial as defined by the requisite protocol and other study specific materials.

Job Description

Role

Citeline Engage is seeking a CRM to join the team.  You will work on the execution and management of Citeline Engage clinical trial projects, including operational reporting, collaboration with client solutions, operations, product management, marketing, and analytics.

This includes project management and ongoing operational support of key clinical trial innovation associated with the integration and ongoing execution of the Citeline Engage initiatives.

As a CRM, you will provide cross-functional support to current workflow and future operational growth required for greater efficiencies and commercialization for product execution.  You will have expertise at defining the optimal site profile for a clinical trial as defined by the requisite protocol and other study specific materials.

As a Clinical Research Manager, you will:

  • Interact with investigators and the site study team to obtain specific information in support of the site selection process and patient referral recruitment.
  • Verify investigator status via Citeline for the purpose of finalizing the site list in support of the CRO’s project team.
  • Have an in-depth understanding of the ICH guidelines, GCP regulations, HIPAA and GDPR.
  • Have working knowledge of protocols (including Waivers, Deviations and Exemptions) and clinical Investigator Brochures (IB) along with comprehensive knowledge of medical and clinical terminology.
  • Provide support to Citeline Business Intelligence, Citeline Product Management, Clinical Study Managers, Lead Clinical Research Associates, Skipta and other project teams at the site level.
  • Create study protocol feedback questionnaires for site feasibility.
  • Attend study team meetings and teleconferences virtually and in person.
  • Develop and execute Investigator and patient recruitment strategies.
  • Understand Sponsors and CRO’s Standard Operating Procedures (SOPs) and Study Specific Procedures (SSPs) and ensure strict adherence to them.
  • Communicate effectively with sponsors and sites via phone and email.
  • Support and train operational team members.
  • Conduct training for clinical trial sites via the web.
  • Create SOPs regarding global site identification.
  • Oversee and support the creation of the initial list of potential sites and a study site identification tracker for further site evaluation and selection activities.
  • Liaise with the Citeline and CRO Functional Leads for the feasibility services to define the goals, scope and requirements of the proposal feasibility and ensure high quality results are delivered.
  • Be flexible and available to travel occasionally to client meetings, sites, and internal meetings.

Qualifications

Qualifications

  • We are looking for a Clinical Research Manager who can demonstrate the following:
  • Minimum of a Bachelor of Science Degree, advanced degrees in the Health Sciences would be ideal.
  • Ideally you will have a minimum of 3 years Phase II & III clinical trial experience working in multiple diseases and therapeutic areas.
  • Any additional medical and/or clinical licenses and/or certifications are a plus.
  • Any experience using Citeline’s TrialTrove and SiteTrove is advantageous but not mandatory.

Additional Information

Why work at Informa Pharma Intelligence?

  • Employee experience is very important to us at Informa Pharma Intelligence.  In addition to joining a supportive, diverse, and ambitious team that welcomes all types of candidates, we are highly flexible with different working patterns and prioritize promotions internally.  Our benefits include:
  • A learning and development plan to assist with your career development.
  • 15 days PTO plus the national holidays for your home country, 4 days for volunteering and a day off for your birthday!
  • Competitive Benefits.
  • Paid parental leave.
  • Work with high quality specialty products and services.
  • Bright and friendly staff who are all “subject matter experts.”
  • Additional training and development for helping you achieve your career goals and aspirations.
  • ESPP - become a shareholder!