I am supporting a Permanent, Senior Project Manager opportunity with a mid-sized bio-pharmaceutical company in Conshohocken, PA! 2 years of oncology experience supporting a Phase II clinical trial through database lock is strongly preferred. This is a great opportunity for growth and allows the ability to fully run a pivotal, Phase II uveal melanoma trial. This role is providing a competitive compensation package and work from home flexibility. Please contact me if interested!
MAIN PURPOSE OF JOB
Coordinating and managing Phase 1-3 assigned protocols and/or programs ensuring all drug development activities are delivered to time, cost and quality.
- Writing up study protocols and related study documents, as required, from the initial scientific discussion.
- Developing and operationalizing biomarker strategies when required in phase I studies, ensuring a successful study
- Establishing, monitoring and maintaining procedures as required to ensure regulatory compliance of phase 1 protocol activities
- Contributing to IND development and other regulatory documents including but not limited to briefing books, regulatory submissions and responses
- Ensuring all program deliverables and milestones are met with quality and within budget
- Provide oversight and accountability of all third party vendors
- Develop study budget and forecasting spend, ensuring study costs stay within predicted spend.
- Play an active part in CRO selection and review of RFP's when required, ensuring the appropriate CRO is identified and properly vetted. Work with internal and external teams as required, ensuring the company FIP/M development projects are initiated and managed in line with company strategy and key clinical and regulatory milestones
- Review and approve CRFs, IRTs and other relevant specifications from a clinical perspective
- Routinely reviews study data and progress of EDC entry; works with data management and clinical sites to resolve data discrepancies. This includes reviewing primary and secondary efficacy and safety endpoints for inconsistency, irregularities, and/or signals.
- Ensure program meets all GCP/ICH Guidelines and is Inspection Ready
- Contributing high level input to regulatory documents such as investigator's brochures and development safety update reports (DSUR); with the ability to create and/or update these where necessary and asking for input where appropriate
- Experience with immunotherapies in Oncology would be an advantage
- Previous experience contributing to INDs
- BA/ BS. or higher in a related scientific subject
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