project manager Job at Randstad
summary
$67 - $73 per hour
contract
bachelor degree
category
computer and mathematical occupations
reference
1010088
job summary:
100% Remote. Leader in medical device manufacturing is looking for a Project Manager for a contract role expected to last 12 months, possible extension, possible temp to perm. This position is responsible for managing the organization and conduct of clinical and engineering studies in compliance with regulatory requirements.
location: Deerfield, Illinois
job type: Contract
salary: $67 - 73 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
qualifications:
skills:
100% Remote. Leader in medical device manufacturing is looking for a Project Manager for a contract role expected to last 12 months, possible extension, possible temp to perm. This position is responsible for managing the organization and conduct of clinical and engineering studies in compliance with regulatory requirements.
location: Deerfield, Illinois
job type: Contract
salary: $67 - 73 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Partner with relevant company functions to develop clinical study plan for each project including timelines and budgets for the clinical program.
- Prepare directly or facilitate preparation of study documentation including protocols, case report forms, informed consent, enrolment feasibility evaluations and all relevant internal plans required for study conduct.
- CRO management (when applicable): Lead the day-to-day oversight of the CRO personnel plus the project budget, deliverables and timeline/milestones.
- Site activities (either directly or managing others): Identify and assess study sites, conduct investigator meetings and site training, prepare and execute research agreements and negotiate study budgets.
- Study monitoring (either directly or managing others): Formulate clinical monitoring plan, perform study initiation visits, manage clinical study monitoring resources, oversee standard interim monitoring visits and closeout activities
- Perform study closeout procedures, directly or through other resources, including accurate completion of critical documents, disposition of study product and preparation of study sites for regulatory authority audits.
- Develop and maintain tracking systems as needed for study management, e.g. screening, enrolment, study completion, (serious) adverse events, budgets and forecasts, milestones.
- Has familiarity with US Federal Food and Drug Administration, ICH/GCP and European Regulatory Authority requirements as applicable to a study (or the countries a study is conducted in).
- Has understanding of the development process from Phase 1 through Phase 4 for drug and/or device trials.
- Possesses working knowledge of research objectives, protocol design, and data collection standards.
- Experience with clinical operations systems including EDC, CTMS, and eTMF.
- Experience in project management practices.
- BA/BS in scientific field with
- Minimum of 5 years clinical operations experience (pharmaceutical, biotechnology or medical device industry) preferably with 1-2 years of direct CPM experience.
qualifications:
- Experience level: Experienced
- Education: Bachelors
skills:
- Project Management
- Medical Device
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 HRsupport@randstadusa.com.
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).
For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
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