DivIHN Integration Inc
Location
Illinois | United States
Job description
For further inquiries regarding the following opportunity, please contact one of our Talent Specialists
Meghna | 224 369 4230
Rakesh | 630 847 0275
Title: Clinical Project Manager
Location: 100% remote is fine.
Duration: 12 months
Top skills needed: Year of experience in Clinical Research (ideally 4-5 years, with at least 2 as a CPM), Proactive and collaborative (we need someone who has a take-charge attitude). , 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.)
How do you prefer to interview followed by onsite or just onsite or just phone Fine with phone/video interviews. If someone is local to the northern Illinois area, can meet them in the corporate office but this is not required.
Will the contractor be required to travel , Maybe this would not be a deal breaker if someone couldn't travel. Someone not be traveling regularly.
If yes, by how much % no more than 25%, but likely less than 5%
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:
Partner with relevant client functions to develop a clinical study plan for each project including timelines and budgets for the clinical program.
Prepare directly or facilitate the 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, and milestones.
Qualifications, Education and/or Experience:
Minimum: BA/BS in the scientific field with a minimum of 5 years of clinical operations experience (pharmaceutical, biotechnology or medical device industry) preferably with 1-2 years of direct CPM experience.
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 an 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
About us:
DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
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