EHS Business Partner focusing on safety culture at leading European manufacturer. Collaborating with management and developing company - wide safety standards in a hybrid role.
About the role
- Oversight Manager responsible for evaluating clinical study monitoring quality at Keenova. Ensuring compliance with regulatory requirements and fostering relationships with investigative sites while implementing process improvements.
Responsibilities
- Evaluating the quality of monitoring activities associated with clinical studies
- Ensuring the protection of human subjects, adherence to study protocols, and compliance with regulatory requirements
- Identifying, recommending, and implementing corrective and preventive actions when necessary
- Gathering and incorporating site feedback on all aspects of study operations
- Ensuring sites are inspection-ready
- Fostering strong working relationships with investigative sites
- Supporting the identification of sites for Monitoring Oversight Visits (MOVs)
- Conducting comprehensive oversight activities including the evaluation of monitoring quality and CRA performance
- Documenting findings and completing comprehensive MOV reports
- Authoring and maintaining study-specific Monitoring Oversight Plans
- Identifying, escalating, and supporting resolution of quality and compliance issues
- Partnering with study teams and sites to ensure inspection readiness
- Collaborating with cross-functional teams to implement process improvements
- Performing Trial Master File (TMF) quality control checks
- Reviewing monitoring trip reports in accordance with oversight plans.
Requirements
- Bachelor’s degree, RN, or higher in a scientific or healthcare-related field preferred
- Minimum of 3 years of clinical monitoring experience
- Minimum of 5 years of experience in the pharmaceutical industry or at a clinical research site
- Prior experience mentoring and/or training Clinical Research Associates (CRAs)
- Proven experience developing and delivering training programs
- Strong knowledge of Good Clinical Practice (GCP) and applicable FDA regulations
- Comprehensive understanding of clinical trial monitoring domestically
- Working knowledge of cross-functional processes and site-level operations
- Excellent written and verbal communication skills, with the ability to present to diverse audiences
- Proficiency with clinical trial systems and tools (e.g., EDC, CTMS, eTMF, IRT) and Microsoft Office applications
- Experience with Veeva Vault Clinical strongly preferred
- Ability to work independently with minimal supervision while contributing to long-term organizational goals
- Strong organizational, planning, and multitasking skills
- Proactive communicator with the ability to engage effectively across all levels internally and externally
- Demonstrated problem-solving skills with the ability to anticipate challenges and implement effective solutions
- Proven ability to build and maintain collaborative relationships across teams, partners, and external vendors.
Benefits
- Total Rewards package including competitive pay and benefits
- Business travel ~50%
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