regional monitoring lead.

　　northbrook , illinois (remote)

　　posted january 17, 2024

　　job details

　　summary

　　$85 - $94.59 per hour

　　contract

　　bachelor degree

　　category life, physical, and social science occupations

　　reference47242

　　job details

　　job summary:

　　As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We are currently partnering with a company known for their leading clinical trials as well as Research & Development. With the goal to constantly develop innovative products, you will feel secure in the fact that you are making a difference. Apply for your dream job now!

　　location: Northbrook, Illinois

　　job type: Contract

　　salary: $85.00 - 94.59 per hour

　　work hours: 9 to 5

　　education: Bachelors

　　responsibilities:

　　This position will be responsible for collaborating closely with internal Clinical Operations, Data Management, and key external stakeholders to deliver high quality data across the entire portfolio. This position will develop, lead, and oversee consistent planning and execution of core clinical operations activities (e.g., site networking, feasibility and selection, monitoring/monitoring oversight strategy, site performance and inspection readiness) for North America in collaboration with the study team.

　　Develop country specific strategy to drive efficient study start up activities, with a key focus on fostering direct relationships with investigator sites to facilitate study conduct.

　　Oversee resource and talent management of regional monitors, whether insourced or via outsourced suppliers, to maintain quality of monitoring that will deliver and achieve Clinical Operations study team goals. Responsible for identifying CRA performance issues and corrective actions.

　　Partner with key internal stakeholders, (Clinical Operations, Legal) to develop integrated business processes and systems to drive standardized, efficient study start-up cycle times globally.

　　Partner with Clinical Operations and other key stakeholders in developing a fit for purpose monitoring and monitoring oversight strategy. Drive and/or oversee monitoring oversight activities at the study-specific, program and portfolio levels to ensure quality of data, site compliance with ICH GCP and study requirements, and monitoring performance.

　　Ensure the quality and compliance of studies, by cultivating an environment of process excellence within the Regional Monitoring organization.

　　Contribute to development of standard processes and tools in line with country regulations, ICH GCP, and industry standards with a focus on study start up, monitoring, and monitoring oversight standard processes and tools to ensure consistency in Sponsor oversight throughout study conduct.

　　Responsible for tracking and oversight of site feasibility, study start-up, monitoring and site management related KPIs and metrics in collaboration with the assigned Clinical Operations study team to ensure risk identification and mitigation and continued improvement to drive quality data and compliance.

　　Be the point of escalation for issues that arise in site engagement, escalating as necessary and keeping the relevant Clinical Operations study team informed of escalation and resolution. Effectively solve problems and use judgment relating to national and international regulations, guidelines, investigator interactions and timelines.

　　Partner with Clinical Operations and Clinical QA, and key internal/external stakeholders to support sponsor and/or health authority site audits/inspections. Contribute to CAPA development and implementation.

　　Manage functional budget, including resource projections and capacity assessment, to ensure adequate and appropriate regional monitoring resourcing for clinical studies and programs.

　　qualifications:

　　Minimum of 8 years' experience in the pharmaceutical industry and/or clinical research organization with at least 5 years' experience monitoring clinical trials. Years of experience will determine job description level (sr. manager vs. assoc. director vs. director).

　　University degree (equal to 4 years of college) in (para-) medical, pharmaceutical, sciences, life-sciences or biosciences.

　　Prior experience in ophthalmology preferred.

　　Previous experience in line management of employees, contractors, and vendors in a remote working environment preferred

　　In-depth and current knowledge of clinical research, including FDA and international regulations, ICH-GCPs, clinical study design and documentation, and conduct of clinical trials.

　　Experience developing processes, tools and training related to sponsor oversight activities

　　Strong experience in establishing effective relationships with investigator sites

　　Ability and willingness to travel as required domestically and internationally up to 25-30%.

　　Supervisory Responsibilities: Yes

　　Excellent verbal and written communication skills.

　　Excellent interpersonal skills; ability to interface with other functions within the company.

　　Ability to work independently, analyze and work with attention to detail, process and prioritize complex information, and problem solve.

　　Ability to collaborative effectively in a dynamic, cross-functional matrix environment

　　Strong strategic thinking, planning, execution, and communication skills

　　skills: CAPA, GCP (Good Clinical Practice), Clinical Study Design, SIV (Site Initiation Visit), ICH Regulations

　　Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

　　At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].

　　Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

　　Applications accepted on ongoing basis until filled.