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Clinical Project Manager

unlimited holidays - extra holidays - extra parental leave - long remote period allowed

Remote:

Full Remote

Experience:

Mid-level (2-5 years)

Work from:

United States

Offer summary

Qualifications:

BA/BS in scientific field, Minimum of 5 years clinical operations experience, Familiarity with FDA, ICH/GCP and European Regulatory Authority requirements, Understanding of drug and device trial development process, Experience with EDC, CTMS, eTMF, and project management practices.

Key responsabilities:

Develop clinical study plan, prepare study documentation
Manage CRO personnel, project budget, deliverables, and timelines
Identify study sites, conduct investigator meetings, negotiate study budgets
Formulate clinical monitoring plan, oversee monitoring resources
Perform study closeout procedures, develop tracking systems

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities:

Partner with relevant Client's 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.

Requirements:

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.
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.