Top 1192 Fda regulatory Jobs in Remote

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Quality Oversight - Senior Manager

TotalMed Medfi -
Remote

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Job Details

Full-time | Contract
$85 - $103 an hour
7 days ago

Benefits

Health insurance
Dental insurance
401(k)
Vision insurance

Qualifications

Teamwork
Microsoft Outlook
Presentation software
Interpersonal skills
Triage
Clinical audit and monitoring
ICH guidelines
Bachelor's degree
Attention to detail
Pharmaceutical company experience
Data interpretation
Organizational skills
Managing projects
Oncology
Cross-functional collaboration
Adobe Acrobat
Cross-functional communication

Full Job Description

We are seeking a talented, experienced, and highly motivated Senior Manager, Monitoring Quality Oversight in Clinical Operations with a passion for new cancer therapy development. This role will be responsible for monitoring quality oversight across multiple studies, thus supporting the Clinical Operations team in the operational execution of our clinical trials.

As a Senior Manager, Monitoring Quality Oversight, you will be responsible for the oversight of the Contract Research Organizations (CROs) monitoring activities to ensure the highest standards of data quality and compliance within clinical operations. This role involves a proactive approach to monitoring oversight, including collaboration with CROs and internal teams to identify and mitigate risks, streamline processes, and implement best practices. The successful candidate will have a strong background in clinical operations, excellent analytical skills, and the ability to provide strategic guidance to ensure the integrity of clinical trial data.

As a member of our dynamic adhering group, you will help to grow the pipeline and you will play a pivotal role in ensuring the quality and integrity of clinical trial data through effective oversight of the CRO monitors.

What you’ll do:

Conduct monitoring quality oversight visits across all clinical studies in North America to ensure compliance with study protocols, regulatory guidelines, and company policies.
Generate and implement comprehensive monitoring quality oversight plans tailored to specific studies, aligning objectives with organizational goals and project timelines.
Review and assess monitoring plans for each study, ensuring they are robust, comprehensive, and reflective of best practices in clinical monitoring.
Evaluate monitoring reports in preparation for oversight visits, identify potential issues or trends and developing appropriate action plans for resolution to address any non-compliance or data quality concerns.
Provide expert guidance and support to clinical operations study teams and service providers on monitoring-related matters, including but not limited to protocol deviations, adverse events, and data quality assessments.
Conduct risk assessments regarding monitoring activities and develop risk mitigation plans to uphold the quality and integrity of clinical trial data.
Stay updated on regulatory requirements, guidelines, and industry best practices related to monitoring oversight, ensuring their effective implementation within the organization and advising on necessary changes.
Assist in the development and maintenance of Standard Operating Procedures (SOPs) related to monitoring oversight, ensuring adherence and compliance across all studies, and updating them as necessary.
Collaborate with CRO monitors to ensure effective management of monitoring activities while adhering to quality standards and fostering a strong, transparent partnership.
Maintain tracking of clinical operations monitoring report review metrics and compliance to ensure continuous improvement in monitoring oversight.
Lead training and development initiatives for study teams and service providers to ensure a clear understanding of monitoring practices, responsibilities, and expectations.
Prepare and present findings from monitoring oversight activities to senior management, providing insights and recommendations for enhancing the overall quality assurance framework.
Identify potential areas for process improvement within the monitoring oversight function, implementing changes that promote efficiency, effectiveness, and compliance.
Monitor adherence to action plans developed during oversight visits and ensure proper follow-up on corrective and preventive actions.
Coordinate with the quality assurance team to support audits and inspections, ensuring that all documentation and processes meet required standards.

Requirements:

Bachelor’s Degree in life science or equivalent combination of education, training, and relevant experience
Minimum 6 years of relevant experience in biotech or pharmaceutical industry, of which a minimum of 3 years of focusing on monitoring oversight within a biotech or pharmaceutical setting.
At least 3 years of experience in oncology.
Experience in Clinical Operations and a thorough understanding of GCP, relevant ICH standards, and FDA/EMA guidelines.
Strong understanding of clinical trial processes.
Proven experience in managing CRO relationships and overseeing monitoring activities.
Self-motivated, with initiative and able to take ownership of, and follow through with, specific tasks.
Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships.
Exceptional analytical skills, with the ability to assess data and trends effectively.
Ability to exercise good judgment and make decisions that are appropriate.
Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment.
Excellent communication and interpersonal skills, with the ability to provide clear guidance and support to cross-functional teams.
Analyze and triage problems, prioritize accordingly, and propose solutions.
Strive for continuous improvement and embrace innovative ideas in daily work.
Strong organizational skills and attention to detail, with the ability to manage multiple projects and deadlines.
Demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint, Adobe Acrobat), clinical trial management systems, data management tools and experience with Smartsheet is a plus.
Ability to travel up to 80%.

#INDZH

Pay: $85.00 - $103.00 per hour

Benefits:

401(k)
Dental insurance
Health insurance
Vision insurance

Education:

Bachelor's (Required)

Experience:

Oncology: 3 years (Required)
monitoring oversight: 3 years (Required)
biotech or pharmaceutical: 6 years (Required)

Work Location: Remote

Quick Apply

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