Clinical Operations Manager - FSP
Primary Location: United Kingdom, Remote Job ID R0000038822 Category Clinical TrialsAbout this Role
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
Finance:
Has ownership of country and site budgetsincluding:
Development, negotiation, and completion of Clinical Trial Research Agreements (CTRA)
Oversight and tracking of clinical research‐related payments
Payment reconciliation at study close‐out
Oversight of Foreign Corrupt Practices Act (FCPA), Denied Party Screening/Office of Foreign Assets Control (DPS/OFAC)and maintenance of financial systems
Financial forecasting in conjunction with SCOM,CRDand other roles
Influences investigators, external partners, and countryoperations to adhere to budget targets and agreedpayment timelines.
Regulatory:
Executes and oversees clinical trial country submissions and approvals for assigned protocolsincluding:
Development of local language materials including local language Informed Consents and translations
Interactions with IRB/IEC and Regulatory Authority for assigned protocols
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
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