Clinical Project Manager II
ClinChoice
contract
Posted on:
Location Type: Remote
Location: United States
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Tech Stack
About the role
- 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.
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical project managementrisk managementbudget developmentprotocol compliancedata monitoringquery resolutionGCPISO 14155ICH-GCPEMEA guidelines
Soft Skills
time managementorganizational skillsinterpersonal skillsconflict managementproblem-solvingcommunication skillsnegotiation skillsinfluencing skillstrainingmentoring