I am supporting a growing pharmaceutical company in Bala Cynwyd, PA. They specialize in rare diseases and are looking for candidates with previous Phase 1 experience. This is a great opportunity for someone looking to grow and take the next step in their career. The role entails coordinating and managing Phase 1-3 assigned protocols and/or programs ensuring all drug development activities are delivered to time, cost and quality. I have a job description and qualifications below. Please contact me if interested!
- Writing up study protocols and related study documents, as required, from the initial scientific discussion.
- Developing and operationalising 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 CRAs and/or 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
- Worked to fully understand and apply the principles of effective clinical project practices, achieving agreed outcomes. Supporting and influencing key stakeholders where required for the successful delivery of projects
- Lead drug development for an assigned program
- Managed multiple project functions both internally and externally, prioritizing workloads and activities to ensure projects meet critical time points and are within budget
- Knowledge and experience in Oncology therapeutic discipline
- Presented high level presentations, both orally and in writing, using organizational skills to complement this
- Ensured an enthusiastic and open attitude towards continuing professional development
- Provided a strong clinical operational focus whilst being able to identify program needs and deliver practical, straight-forward, solutions which work first time
- Proactively designed and delivered optimized phase I/Ib clinical protocols
- Vendor Oversight experience
- Understands and applies the principles of GCP. Creating and maintaining healthy, creative, relationships with study sites and principle investigators; helping to support and influence where required
- Proficient in MS Word, Excel, Power Point, Outlook, MS Project, SharePoint
- 3-5 years pharmaceutical industry clinical trial management experience
- Bachelor's degree required
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