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Research Manager

Company: Cerner Enviza
Location: Trenton
Posted on: May 16, 2022

Job Description:

JOIN A GROUP OF EXTRAORDINARY PEOPLE
Research Manager- Regulatory & Safety

The Research Manager- Regulatory & Safety is a critical hire for our business! The healthcare research space is becoming increasingly important, and you will have the chance be part of an industry that is continuing to evolve and grow. This is a great opportunity for someone with a few years of relevant experience to expand on their knowledge while working for a global corporation.

The Research Manager- Regulatory & Safety works closely with the Evidence Generation Lead and is responsible for managing a high volume of research projects ensuring they are managed so as to be delivered on time and within budget. The Research Manager- Regulatory & Safety is responsible for independently executing tasks which support the research process for our Real-World Research and Regulatory projects.

As Research Manager- Regulatory & Safety you will:

Be primarily responsible for the daily tasks associated with the project management of regulatory engagements which includes accuracy of survey programming for content, skip logic, data checking, managing third party vendors and checking the work they produce, opening POs and invoices.
Maintain appropriate project documentation including meeting minutes, decision logs and Trial Master File content and maintenance.
Supports real-world qualitative research conducts cognitive interviews, attend or listen to qualitative research interviews; reviews/revises qualitative reports. Ability to code qualitative interviews utilizing MAXQDA or similar software.
Assists with site identification, if needed, and creates & site training materials, and participates in on-site or remote site initiation trainings. Site management and monitoring.
Performs tasks required for Institutional Review Board (IRB) submissions and IRB close outs.
Completes Adverse Event compliance and reconciliation.
Proactively identifies project issues and works with project leadership and team members to define mitigation strategy and approach.
Documenting all necessary information requirements set forth by ISO guidelines

Basic Qualifications
At least 6 years total combined higher education and related work experience, including:
At least 1 years experience at a Licensed health care practice, clinical research, epidemiology and/or biostatistics work experience
At least 5 years higher education and/or additional work experience directly related to the duties of the job

Preferred Qualifications
Bachelor's degree in life sciences subject
Strong project management and proven ability to plan and prioritize work to meet commitments needed to achieve results.
Strong working knowledge of research process and procedures gained from working in Real-World Research, Public Health, Clinical or Market Research in the pharmaceutical/healthcare industry.
Experience working as part of an integrated team, with demonstrated ability to manage workflow and communication with clients.
Experience in Oncology and/or Rare Diseases is highly desirable
Experience with qualitative research or secondary databases is also desirable.

Expectations
Ability to travel for client meetings, attendance at conferences, or internal meetings.
Willing to work additional or irregular hours as needed and allowed by local regulations
Work in accordance with corporate and organizational security policies and procedures, understand personal role in safeguarding corporate and client assets, and take appropriate action to prevent and report any compromises of security within scope of position
Perform other responsibilities as assigned

Cerner Enviza is a leading global healthcare consulting firm and trusted advisor to many of the world's top pharmaceutical, biotech, and medical device & diagnostic companies. By supporting the work of Cerner Enviza, you will work with world-class healthcare companies, helping them improve global access to medicines by connecting science and research. Cerner Enviza is passionate about our people, our business, and our clients and is proud to foster a culture that contributes to the health and well-being of humankind. Leading through innovation, we consistently challenge ourselves to discover and embrace new and creative ways to deliver exceptional insight for clients.

Keywords: Cerner Enviza, Trenton , Research Manager, Executive , Trenton, New Jersey

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