Clinical Research Manager
We are currently seeking a Clinical Research Manager for our client in RTP, NC. The ideal candidate will have experience with Medical Devices and/or Biologics and be able to Design and Write Protocols for Studies on Multiple Projects.
- Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
- Provide accurate and up-to-date study information and metrics to management; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues
- Study Documents: accountable for all study documents for assigned studies; prepare protocol and ICF and may assist with preparing key documents such as, Investigator Brochure, FDA Briefing Documents, internal/external presentations, etc., develop and approve assigned study budget(s), prepare protocol amendments
- Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans
- Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members.
- Track key study metrics using tracking tools (creating and maintaining documents, tables, databases, spreadsheets, and files)
- Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study deliverables
- Lead feasibility assessment and selection of countries and sites for study conduct
- Implement appropriate systems, standards, and processes to ensure quality at the level of investigative sites, vendors, and data
- Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team
- Review and approve vendor user requirement specifications for systems, devices and diaries utilized in assigned study(ies)
- Provide oversight and direction to study team members for study deliverables, study start up and oversight: Accountable for the identification, bid process, and final selection of vendor(s), oversee vendor identification and activities.
- Resolve issues timely, establish strategies for the collection of data, selection of sites, issue identification, monitoring and investigator communications, prepare protocol training slides for use at site initiations and investigator meetings, successfully execute Investigator Meetings or site initiations
- Manage and lead cross-functional study teams, including vendors
- BA/BS in life science degree or related degree.
- Minimum Five years clinical trial experience.
- Strong knowledge of ICH/GCP guidelines.
- Strong knowledge of protocol and clinical development processes, clinical study design, study planning and management, and monitoring.
- Working knowledge of medical terminology, anatomy and physiology and an excellent knowledge of applicable U.S. regulations and guidelines.
- Experience with orthopedic, spine and biologic clinical investigations
- ACRP or SOCRA certification
- International Regulations and Guidelines Experience
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