Clinical Operations Manager - FSP
Primary Location: United Kingdom, Remote 求人ID R0000038822 Category Clinical TrialsAbout this Role
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
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