Clinical Trials Operations Lead
1 week ago
Position: Clinical Trials Operations Lead
Responsibilities: As the Clinical Trials Operations Lead, you will be responsible for overseeing the operational aspects of clinical trials at a local level. Your leadership will ensure that recruitment goals, timelines, budgets, and quality standards are met consistently.
Team Leadership: You will guide the local trial team to maintain the integrity of trial execution, prioritize patient safety, and ensure that all local and regional trial components adhere to regulatory standards. This role requires effective collaboration with various functions throughout the planning, execution, and conclusion of trials.
Regulatory Compliance: You will navigate a complex environment of Good Clinical Practice (GCP) and regulatory requirements while working on global clinical trials with diverse, multidisciplinary teams. Your role will involve representing the organization in meetings with regulatory bodies and investigational sites.
Project Management: The position demands a strong ability to manage multiple assignments simultaneously, balancing conflicting priorities while ensuring project deliverables are met. You will also contribute to the design and implementation of innovative methodologies as part of a working group.
Collaboration: In partnership with the Site Monitoring Lead and Clinical Research Associates (CRAs), you will serve as the primary contact for CRAs, investigators, and site personnel throughout the trial lifecycle.
Qualifications:
- Exceptional communication skills, particularly in complex, cross-functional environments.
- Proven project management and stakeholder engagement abilities.
- In-depth understanding of the clinical development process and regulatory frameworks.
- Technical expertise across all facets of clinical trial operations.
- Leadership capabilities in managing complex situations and influencing stakeholders.
- Strategic mindset with the ability to identify risks and develop mitigation strategies.
- Strong organizational skills to prioritize tasks and optimize resource utilization.
- Willingness to travel as required.
Work Environment: This position is primarily remote, with occasional travel required for onsite engagements. Compensation is structured as an exempt salary, with benefits including paid holidays and sick leave as per local regulations.
Education: A Bachelor's degree with a minimum of 6 years of clinical research experience, preferably within the pharmaceutical sector; or a Master's degree/PharmD with at least 4 years of relevant experience; or a PhD/MD with a minimum of 2 years of clinical research experience.
Company OverviewNexPro Technologies Inc. specializes in delivering comprehensive, responsive, and value-oriented IT consulting and staffing solutions.
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