Clinical Operations Manager - FSP

Primary Duties:

General

• Managescountrydeliverables,timelines,andresultsforassignedprotocolstomeetcountrycommitmentsincluding:

• Quality and compliance in assigned protocols in country  

• Coordinates and liaises with Clinical Research Managers(CRMs), Clinical Research Associates (CRAs) and Clinical Trial Coordinators (CTCs),Finance and Legal ifappropriate toensure country deliverablesare obtained for submissions, budgets, CTRAs and local milestones  

• Collaborates closely with Headquarter to align country timelines for assigned protocols

• Provides support and oversight to local vendors as applicable 

• Oversees CTCs as applicable    

• Contributes to thedevelopment of local SOPs

• Oversees and coordinates local processes,clinical and ancillary supplies, import and export requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management

• Enters and updates country information in clinical and finance systems

• Contributesor leadsinitiatives and projects adding value to the business

• Contributes strongly to the COM team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuousimprovement,and providing training as appropriate/required

• Contributes to COM teamand other Country Operations roles’knowledge by acting asa buddy/mentor and as a process Subject matter Expert (SME),sharing best practices, making recommendations for continuousimprovement,and providing trainingas appropriate/required

• Completestraining assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training 

• Adheresto EP and Client SOPs and processes

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 local language and 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

• Problem solving is essential

• 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