Clinical Project Manager

Beacon Hill - Job Details
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Clinical Project Manager

Brookline, Massachusetts

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Full Time

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NA

Brookline, Massachusetts

Full Time

NA

January 13, 2023

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Job ID: 1320563_1673627686

January 13, 2023

Job ID: 1320563_1673627686

Job Summary

Job Id: 1320563_1673627686 Apply Now

Responsibilities:

- Oversees and supervises clinical operations, vendors/CROs and ensures that these activities are conducted in accordance with applicable regulatory requirements and guidelines including company SOPs, ICH-GCP guidelines, regulatory authority regulations and patient safety standards, as applicable

- Proactively manages clinical study processes and travels to clinical sites in North America

- Ensures the identification, recruitment and selection of appropriate clinical sites & investigators and maintains strong relationships with external experts and Investigators to ensure effective execution of clinical projects

  • Develops and writes clinical study protocols and plans, IRB submission documents, CRFs and clinical study reports
  • Facilitates training to clinical study team per study protocol and supports regulatory submission and documentation
  • Contributes and implements all activities required for the generation of high-quality data deliverables on time and on budget (e.g., collaboration with statisticians and data managers, data overview, etc.)
  • Analyzes, interprets and presents results of clinical studies to internal and external stakeholders including participatesin writing scientific peer-reviewed publications

Requirements:

MSc degree in life sciences, biomedical or other related discipline; PhD or MD - preferred

  • GCP/CRA certified
  • 4+ years of experience managing clinical development activities in medical device industry with at least 2+ years in Clinical Affairs. Previous experience in conducting medical device/IVD clinical studies - preferred

Proven knowledge of medical device, IVD clinical development and oncology, FDA and other applicable guidelines

  • Prior experience with clinical development planning, regulatory requirements and documents, study design, biostatistics, monitoring, data handling, data analysis, report and manuscript writing
  • Demonstrates a proven ability to both independently complete and lead peers in completion of complex plans, i.e., study protocols, selecting appropriate methodologies, study timelines, and evaluation tools
  • In-depth understanding and experience across the clinical operations value chain, with a track record of success in study planning, execution, data management, study report
1320563_1673627686

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About Beacon Hill

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

We look forward to working with you.

Beacon Hill. Employing the Future™