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Clinical operations manager - fsp

Harrow
Clinical operations manager
Posted: 18 February
Offer description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Primary Duties: General Attends meetings with COMs Data Cleaning and Consolidation: Cleaning scattered data from different systems using Python and consolidating it into a unified reporting structure. Anomaly Detection: Establishing automated alert mechanisms to identify erroneous data entries and operational risks. Automating repetitive validation checks Develop tools to support oversight - review trends Build dashboard to support recruitment rates, trends, study timelines, real time operational oversight API Integration: Enabling automated data flow between systems to reduce manual data transfers. Ad-hoc Analyses: Delivering fast, data-driven customized analyses to address urgent operational needs. Documentation: Preparing technical documentation and guides for the developed tools and code structures. SME & PoC Activities: Managing pilot projects for the integration of new technologies (AI/ML) into processes and providing technical SME support to teams. Skills and Education: Bachelor's Degree in Business Finance/ Administration / Life Science or equivalent Hea lth Care related experience 5 ‐ 7 years clinical research or combined experience in Clinical Research and Finance/Business Expertise of core clinical systems, tools, and metrics Excellent verbal and written influencing and training/mentoring skills, in English Strong coordination and organizational skills Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up Able to indirectly influence investigators, vendors, external partners, and country managers to address and resolve issues, with minimal support from the SCOM or manager. Ability to make decisions independently with limited oversight from SCOM or manager Requires a strong understanding of local regulatory environment Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally Ability to lead a team of CTCs as applicable Ability to proactively identify issues and risks, analyze root cause and propose solutions and escalate as applicable Effective and efficient time management, organizational and interpersonal skills, and conflict management skills High sense of accountability and urgency to prioritize deliverables Expertise of core clinical, regulatory, and financial systems, tools, and metrics, Strong communication, leadership, and negotiation skills as well as excellent influencing and training/ mentoring skills Ability to focus on multiple deliverables and protocols simultaneously Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people Positive mindset, growth mindset, capable of working independently and self - driven Ability to directly influence site staff

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