Clinical Operations

  • location: Bridgewater, NJ
  • type: Contract
  • salary: $60.18 - $70.80 per hour

description

Chat with me now! - https://flashrecruit.com/jobs/296912

Job Title: Clinical Trial Operations Manager III

Job Summary

  • Provides input into identifying implications of study progress on overall timeline goals and conduct plans.
  • Provides input into content and execution of investigator meetings and may present selected topics.
  • With oversight, develops informed consent form and coordinates input.
  • With oversight, provides point of contact for site questions relating to study conduct issues.
  • Participates in the implementation of key organizational process improvement initiatives.
  • Responsible for serving 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.
  • Lead the multi-disciplinary team responsible for study completion.
  • Writes and reviews abstracts/manuscripts, etc. for presentation/publication at internal/external meetings. experience in Clinical Trials or Clinical Project management.

Job Responsibilities

  • Capable of interacting effectively with scientists and managers within and outside Trial Operations Department.
  • Strong interpersonal and communication skills (verbal and written)
  • Ability to handle multiple task and to prioritize, strong organizational and presentation skills
  • Leadership / Vendor Management skills
  • Project Management skills
  • Decision-making and problem-solving skills
  • Ability to work autonomously and to efficiently & effectively provide status reports
  • Ability to anticipate and timely escalate issues and to define appropriate action plans
  • Good cross-functional team leader who fosters team spirit and team motivation (team work)
  • 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 (CROs etc)
  • Strong English skills (verbal and written if English is the second language)
  • Ability to adapt and be flexible to change and managing internal and external impediments
  • Understanding of data base concepts preferred
  • Knowledge or ability to rapidly gain knowledge with programming/query languages
  • Knowledge of industry data management standards and practices

Education & Qualifications

  • Bachelor's degree (advanced degree preferred) plus at least 3 years of experience in pharmaceutical, industry or clinical-related discipline including at least 2 years clinical research experience, including 2 years of trial operations management.

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

Chat with me now! - https://flashrecruit.com/jobs/296912

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