Senior Manager, Study Operations, MA-US

Responsibilities :

Evidence Generation Execution

• Lead feasibility assessment and selection of countries and sites for study conduct
• Manage and lead cross-functional study teams, including vendors
• Responsible 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 issues

• Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables
• Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data
• Oversee 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 plans
• Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members
• Provide 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 applicable
• Participate 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 inspections
• Demonstrable understanding of late phase clinical development within a Medical Affairs setting
• In-depth knowledge of global drug development, product lifecycle management, and clinical study design

Benefits

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Referral bonus program

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