Senior Manager, Study Operations, MA-US

3 weeks ago

Northbrook, United States Astellas Pharma Inc. Full time
Responsibilities :

Evidence Generation Execution

Lead feasibility assessment and selection of countries and sites for study conductManage and lead cross-functional study teams, including vendorsResponsible for financial oversight of the program(s), requiring a strong financial acumen; proactively partners cross-functionally for updates to timelines and budgets.Development of RFPs, selection of CROs/vendors Provide accurate and up-to-date study information within CTMS and other relevant tracking systems and provide regular updates of study progression to MA leadership and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issuesLead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverablesImplement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and dataOversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plansEnsure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team membersProvide oversight and direction to study team members for study deliverables

Quality

Lead vendor oversight, as applicable to study type, in the management of day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH, GPP guidelines and other regulatory requirements, as applicableParticipate in process improvement and quality-related initiatives associated with study execution and deliverables; participate in establishment of best-in-class processes and standards for study conduct

Organizational Context

Reports to Sr. Director / Director Evidence Generation Operations

Collaborate within M&D: DevelopmentRegulatory AffairsPharmacovigilance Collaborate with divisions outside of M&D: AIALegalEthics & Compliance Requirements

Qualifications

Required

Educational Background: Bachelor’s in Sciences or health-related field with at least 5 years global vendor oversight and clinical trial management experience in CRO, Pharmaceutical or Biotech company.Key Competencies: Strong clinical study management skills (including project and financial management)Excellent leadership, negotiation, and management skillsCRO/vendor management experience, including experience in audits and inspectionsClear demonstration of strong negotiation and influencing skills that lead to changeIn-depth knowledge of key interfacing organizations (finance, development, supply chain, regulatory etc.)Business-fluent EnglishKnowledge and/or experience working with groups across multiple countries and of varied cultural backgroundsDemonstrate strong organizational skills including ability to prioritize Ability to work virtually

Preferred

Experience with internal audits and regulatory inspectionsDemonstrable understanding of late phase clinical development within a Medical Affairs settingIn-depth knowledge of global drug development, product lifecycle management, and clinical study design

Benefits

Medical, Dental and Vision InsuranceGenerous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks401(k) match and annual company contributionCompany paid life insuranceAnnual Corporate Bonus and Quarterly Sales Incentive for eligible positionsLong Term Incentive Plan for eligible positionsReferral bonus program

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.

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