Clinical Operations Manager - FSP

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.

Skillsand Education:

• Bachelor's Degreein Business Finance/ Administration/ Life Science or equivalentHealth Care related experience required

• 5‐7 years clinical research or combined experience in Clinical Research and Finance/Businessrequired

• Expertise of core clinical systems, tools, and metrics

• Excellentverbal 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 theseimpactstudy start-up

• Able to indirectly influence investigators, vendors, external partners, and country managers to address and resolve issues, with minimal support from theSCOM or manager.   

• Ability to make decisions independently with limited oversightfrom SCOM or manager

• Requires a strong understanding of local regulatory environment

• Ability to proactively develop risk managementand mitigation plans in the country and resolve issues locally

• Ability to lead a team of CTCs as applicable

• Ability to proactivelyidentifyissues and risks,analyze root cause and propose solutionsand escalate as applicable

• Effective and efficient time management, organizational and interpersonalskills,and conflict management skills

• High sense of accountability and urgencytoprioritize deliverables

• Expertise of core clinical, regulatory, and financial systems, tools,andmetrics,

• 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 remotevirtualenvironment with a wide range of people

• Positive mindset, growth mindset, capable of working independently and self - driven

• Ability to directly influence site staff