Opportunities

Position Status:

Fully remote or hybrid if within a commutable distance
Full-time – Permanent

Company

Our client company is a well-established clinical-stage T-cell focused biopharmaceutical company. Their leading drug candidate is uniquely positioned to address key unmet medical needs in immune-oncology and other diseases.   They are partnered with industry and academic leaders to investigate combinations with leading immunotherapeutics and to rapidly expand into additional combinations such as CAR-T.   They are well established and rapidly expanding.   We are assisting them in identifying qualified candidates for this position on an exclusive search basis.

Location

This position is a new position with our client and can be hybrid or fully remote depending on the location and desires of the candidate selected.  Our client company is located in Maryland

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Position Summary

Responsibilities

• Provides support for the day-to-day execution of clinical trials following GCP and company SOPs. Maintains all trial data logs and ensures accuracy of all study materials and partners with other Clinical Project Managers to oversee study conduct
• Supports Clinical Project Managers to plan and track all clinical activity and monitor all trials. Oversees and manages vendors, reviews contracts/budget, supports invoice process, and IP management. Accountable for trial documentation and ensures inspection readiness of respective clinical trial(s) at all times
• Works closely with Clinical Project Managers to develop study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, Laboratory Manual, Patient Diary, Study Reference binders, Pharmacy Manual, Clinical Data Review Plan, Clinical Database specifications development, Clinical Study Report (CSR), clinical abstracts, posters, and manuscripts
• Performs necessary literature searches for drafting document content
• Effectively communicate deliverables needed for clinical regulatory documents, writing process, and timelines to other team members
• Responsible for QA/QC of the submission documents to support publishing process
• Supports or conducts sponsor quality monitoring/oversight visits to sites and/or CRAs performance assessment in adherence to GCP, corporate SOPs and protocol as needed
• Collaborates with Clinical Project Managers to create, manage, and report timelines, risk registry, operational logistics, and assesses study process to ensure all stakeholders are informed and aligned on deliverables

Qualifications

• Education:  BS, MS, or Ph.D. degree in a scientific or healthcare discipline preferred
• 3 to 15+ years of experience in medical or scientific writing and clinical development in pharmaceutical or biotech (e.g., CRO or sponsor).    This position may be at the Senior Medical Writer level for those with more experience.
• Experience in management of oncology trials or pediatric trials preferred
• Demonstrates effective written and verbal communication skills
• Working knowledge of ICH Good Clinical Practice guidelines
• Working knowledge of project management concepts (e.g., scope, resources, timeline, risk management)
• Demonstrates ability to handle multiple tasks and deadlines
• Self-motivating and able to work on problems of moderate scope and complexity where analysis of situation or data requires a review of a variety of factors
• Able to travel domestically (~5% or less, not applicable during COVID-19 pandemic)

Disclaimer:  This is an unofficial document prepared by OncologySearch.com to provide basic information concerning the position.   The company we are conducting this search for has the official job description.