Clinical Operations Manager - FSP

Primary Duties

• 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.
• 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.

• Bachelor'sDegree in Business
  
  Finance/Administration/Life Scienceorequivalent Health Carerelatedexperiencerequired
• 5‐7yearsclinicalresearchor combined experience in Clinical Research and Finance/Business required
• Expertiseofcoreclinicalsystems,tools,and metrics
• Excellent verbal and written influencing and training/mentoring skills, in English
• Strongcoordinationandorganizationalskills
• Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up
• Abletoindirectlyinfluenceinvestigators,vendors,external partners,andcountrymanagerstoaddressandresolveissues,withminimalsupportfromthe SCOM or manager.
• Abilitytomakedecisionsindependentlywithlimitedoversight from SCOM or manager
• Requires a strong understanding of local regulatory environment
• Abilityto 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 elevate as applicable
• Effective and efficient time management, organizational and interpersonal skills, and conflict management skills
• High sense of accountability and urgency to prioritize deliverables
• Expertiseofcoreclinical,regulatory,andfinancialsystems,tools, and metrics,
• Strong communication,leadership,andnegotiationskillsaswellasexcellentinfluencingandtraining/ mentoring skills
• Abilitytofocusonmultipledeliverablesandprotocolssimultaneously
• 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