Clinical Project Manager - Remote

Stefanini Group is hiring!
Stefanini is looking for Project Manager Business Professional/Clinical Project Manager for Deerfield, IL Location.
For quick Apply, please reach out to Rohit Manhas - call: (248) 728-2575 / email: [email protected]
Work shift (days/times) - Monday - Friday (40 hours)
Work Location - Deerfield, IL
Shift: 1st Shift
Summary
Responsible for managing the organization and conduct of clinical studies in compliance with Clinical Operations policies and procedures, Regulatory (Health) Authority requirements and guidelines, and International Conference on Harmonization (ICH) Guidelines in support of global business objectives. Reports directly to the Director of Clinical Operations in Deerfield, Illinois. The Clinical Project Manager plans for and executes the required global or domestic clinical development plan of drugs and devices to generate data to support the launch and expansion of critical treatments for patients. This data serves to globally support regulatory submissions, post-marketing complaint handling and promotional claims for marketing strategies. The Clinical Project Manager also consults with regulatory, engineering, marketing, sales and research groups in problem solving efforts.
Essential Duties And Responsibilities

• 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.
• Partner with relevant functions to develop clinical study plan for each project including timelines and budgets for the clinical program.
• 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.
• 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.
• Develop and maintain tracking systems as needed for study management, e.g. screening, enrolment, study completion, (serious) adverse events, budgets and forecasts, milestones.
• 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
• CRO management (when applicable): Lead the day-to-day oversight of the CRO personnel plus the project budget, deliverables and timeline/milestones.

Qualifications, Education And/or Experience

• Experience in project management practices.
• 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
• Minimum: 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.
• Experience with clinical operations systems including EDC, CTMS, and eTMF

Top Skills Needed
Year of experience in Clinical Research (ideally 4-5 years, with at least 2 as a CPM), Pro-active and collaborative (we need someone who has a take-charge attitude). May not be obvious on a resume, but we need someone who has worked on a study from start to finish (i.e., has been involved in site selection, as well as, contracting, study execution and closeout. Many CROs have separate groups for certain activities within a study.)

• Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.