Job Title

FSP Clinical Research Manager- Remote US The Clinical Research Manager is accountable for execution and oversight of local operational clinical trial activities and has ownership,oversight,and impact on local regulatory and financial compliance, at a country operations level at the client in compliance with ICH GCP and country regulations.The position has a significant impact on how a country can deliver country-specific trial commitments andobjectives,especially during the study. As a customer-facing role, this position will build business relationships and represent Client with investigators, functional outsourcing partners and other external partners and therefore have a significant impact on country-level customer relationships. In this role, you willbe responsible for: Effectively conducting clinical studies and developing the pipeline, whilemaintaininglocal regulatory and compliance requirements in countries Making decisions independently and oversee important activities relevant to clinical research activities in the country according to predetermined global policies and commitments with the support, oversight and supervision of the Country Research Director or Therapeutic Director. Building andmaintainingprofessional relationships with investigators and other external stakeholders, withstrong communication, educational/pedagogic,diplomatic,and empathic skills Overseeing country commitments,compliance,and training needs.Additionally, business leadership and alignment with corporate requires thatindividual hasabilityto lead across several dimensionssimultaneously. Working collaboratively with Country and Regional Operations; Pharmacovigilance, Regulatory, Global Medical Affairs and Global Human Health internally; and with external functional outsourcing vendors Coordinating and aligning the regional and broader organization Building andmaintainingrelationships with investigators and other external partners and promote Clientsreputation. RepresentingClient in Pharma industry issues and in seeking influence in external R&D environment, in collaboration with CRD Accountable for performance and compliance with assigned protocols in relation to ICH/GCP and country regulations along with client policies,proceduresand adverse event reporting requirements Proactively driving/tracking execution and performance of deliverables/timelines/results to meet country commitments; collaborating with local clinical operations roles; and forecasting country needs Overseeing quality and compliance including training. Oversight of CRAs and CTCs including QC visits, Monitoring Visit Reports, escalation of performance issues and training needs;overseesCRMs assigned toclient. Collaborating as the point of contact with outsourcing vendors, investigators, and other external partners; overseeing country and site validations, site selection, and recruitment; and responsible forclientstrialeducation to site. Collaborating internally with local PV, Regulatory, GMH/GHH to align key decisions in countries and supporting local/regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations. Requirements: Education: Bachelors degree in science or comparable Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries Thorough understanding of the drug development process Fluent in local office language and in English, both written and verbal Experience: Minimum of 5-6 years in clinical research in which some experience should be in a CRA capacity. 1+ years of experience as a PM or CTL managingprojects. Must havea strongunderstanding oflocalregulatory environment, country regulations, client policies and procedures, quality standards. Strong scientific and clinical research knowledge isrequiredfor this position. A strong understanding of clinical trial planning,managementand metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously. The role will require proven ability to collaborate and lead high performing cross-functionalteams alsoin a virtual environment. The position requires strong leadership skills (scientific and business) andabilityto coordinate and lead local teams to high performance. Good organizational and time management skills Working knowledge of ICH, FDA, local regulatory requirements, IRB/IECand other applicable regulations/guidelines; familiarity with investigator start up documents;previousinteraction with operational project team and investigative sitespreferred. Excellent communication skills, oral andwritten. Self-motivation with the ability to work under pressure to meetdeadlines. Works well independently as well as in team environment tail and processoriented. Positive attitude and approach Interact with internal and external customers withhighdegree of professionalism anddiscretion. Multi-tasking capability. Good computer skills with good working knowledge of a range of computer packages Ability to lead and develop juniorstaff. Flexibleand adaptable to a developing work environment Travel Requirements: 20-40 % travel may berequired. International and Domestic Travel may berequired, including overnight stays as necessary consistent with project needs and office location (this will vary based on country and project needs Pay Range: $135-150K Benefits: All job offers will bebased on a candidates skills andpriorrelevant experience, applicabledegrees/certifications,as well as internal equity and market data.Regular,full-timeor part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. LI-Remote Learn more about our EEO & Accommodations request here.