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Clinical Operations Manager - FSP

Parexel
1 month ago
On-site
United Kingdom
Administration, Operations & Management

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 Health 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