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Clinical operations manager - fsp

Clinical operations manager
Posted: 15h ago
Offer description

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,CRD?and 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 ? Skills and 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,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 remotevirtualenvironment with a wide range of people Positive mindset, growth mindset, capable of working independently and self - driven Ability to directly influence site staff? \LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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