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ClinChoice logo
ClinChoice

The Standard of Excellence

Clinical Project Manager II

Clinical OperationsClinical OperationsOtherRemoteSeniorTeam 1,001-5,000Since 1998H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

121 days ago

Salary

0

Seniority

Senior

Bachelor Degree3 yrs expEnglishGCP

Job Description

Clinical Project Manager II

ClinChoice

• Manages the delivery of study requirements to the protocol and regulations such as GCP and ISO 14155, the site needs and the required timelines set for the project. • Apply principles, concepts and techniques for effective and proactive project management of a clinical study. • Balances resource constraints (i.e. time, money, people, and equipment) against deliverables. • Develop clinical study budget and may assist in quarterly departmental budget reviews. • Seeks input from higher-level clinical experts or program management as issues warrant. • Leverage experience and work with collaborative team members to recommend and implement methods for improving processes and addressing issues within the clinical operations department. • Implement and maintain risk-based monitoring processes to drive efficient and effective study management. • Oversee and review data and/or monitoring reports for protocol violations and serious protocol deviations, and proactively address violations/deviations, to assure protocol and GCP compliance. • Train and mentor more junior staff on monitoring, internal procedures, and query resolution to assure alignment and GCP compliance.

Job Requirements

  • Bachelor's or advanced degree in a relevant scientific discipline.
  • 3-5 years of medical device clinical project management experience.
  • Experience with sleep and respiratory studies are required.
  • In-depth knowledge of ICH-GCP, EMEA guidelines and other relevant regulations and guidelines.
  • Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety.
  • Ability to proactively develop risk management and mitigation plans in country and resolve issues locally.
  • Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills.
  • High sense of accountability and urgency to prioritize deliverables.
  • Strong communication skills and negotiation skills as well as excellent influencing and training/mentoring, both written and verbal.
  • Ability to focus on multiple deliverables and protocols simultaneously is essential.
  • Positive mindset, growth mindset, capable of working independently and being self-driven.
  • Able to directly influence Clinical Operations staff.

Benefits

  • competitive salary
  • professional development opportunities

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