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Clinical Trial Manager

Planet Pharma

Reference: 629391Posted: 2026-07-30Location: Redwood City, CaliforniaCompany: Planet Pharma GroupContact: ApplicationsEmail: View email address on click.appcast.io Clinical Trial ManagerThe Opportunity:This is a unique opportunity for a Clinical Trial Manager (CTM). You will be responsible for independently managing one or more Phase 1-3 studies or complex components of larger trials with cross-functional oversight and vendor management.Responsibilities:Apply advanced expertise and exercise considerable latitude to determine objectives and to develop effective solutions to guide the successful completion of complex assignments under limited supervisionParticipate in the Clinical Study Execution Team (CSET) discussion and may lead aspects of the meeting agenda as it pertains to vendors, study metrics, etc.Drive site activation and document readiness activities; analyze enrollment and operational metrics, supporting study lead in decision-makingParticipate and sometimes lead meetings internally and externally with CROs, vendors, and multi-functional teams with minimal supervisionLead TMF reconciliation and inspection readiness activitiesSupport the review of study documents such as protocols, ICFs, CRFs, monitoring plans, etc.Lead department process improvement initiativesParticipate in CROs/vendor trainings as it relates to a limited aspect of study requirementsManage the CRO and some ancillary vendors and ensure deliverablesMay participate in the interview process for similar or junior roles within Clinical OperationsMentor and support Clinical Trial Assistants (CTAs) and Clinical Trial Management Associates (CTMAs)Follow up and follow through on team action items and identification, escalation, and resolution of issues as needed.Review and identify trends when performing routine data surveillance of data listings, and support in the preparation of interim and final Clinical Study Reports and resolution of data discrepancies.Support other Clinical Operations activities as appropriate.Required Skills, Experience and Education:BS, BA, or RN in a relevant scientific discipline.5-7+ years of relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research related experience.Advanced knowledge of FDA and EMA Regulations, ICH Guidelines, GCP, and familiarity with standard clinical operating procedures.Strong communication and coordination skills; global trial experience and strong operational judgement.Proactive contributor to trial execution and issue resolution, with strong ownership of responsibilities for complex studies with multiple sites.High sense of priority and commitment to excellence in the successful execution of deliverables.Ability to analyze operational data, perform with an emphasis on quality, timeliness and multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.Travel may be required (~15%).Preferred Skills:Decision-making skills.Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).Oncology experience, early and/or late stage, strongly preferred.

Vacancy posted 4 days ago
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