Clinical Operations Manager - FSP

Primary Duties

• 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.

• Bachelor's Degree in Business Finance/Administration / Life Science or equivalent Health Care related experience required.

• 5-7 years clinical research or combined experience in Clinical Research and Finance/Business required.

• 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 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.

• 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.