Study Manager, Evidence Generation Operations, MA-US

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

This position is based in Northbrook, Illinois. Remote work may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

The Senior Manager Study Operations will mainly be asked to manage less complex studies, i.e., Observational studies, secondary use of data

• Responsible for operational planning, oversight and/or execution of Medical Affairs data generation activities, including Company Sponsored Research (interventional, non-interventional, and HEOR studies) and Collaborative Research (CR).

• Plan, initiate and execute assigned studies with operational excellence:

• Accountable for effective management of budgets, timelines and resources for assigned clinical studies, and implementation of appropriate standards and processes to ensure clinical study quality

• Responsible for effective training and management of interactions with study team, study sites and vendors for assigned clinical studies

• Participate in best-in-class initiatives to improve study execution standards and processes and to ensure quality of study deliverables

• The scope of this position is post approval data generation research studies including Phase IIIb/IV. This position may oversee management of multiple studies.

[Japan Only: accountable for each process (Planning, Data management, Stat, Medical writing) to carry out the Post-Marketing Study (PMS) of assigned product. Responsible for implementing the PMS in accordance with GPSP regulations and company procedures. Cooperate with PV/RA to prepare the study plan as a part of RMP (Risk Management Plan) and reexamination application materials.]

Essential Job 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:

• Development

• Regulatory Affairs

• Pharmacovigilance

• Collaborate with divisions outside of M&D:

• AIA

• Legal

• Ethics & Compliance

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 skills

• CRO/vendor management experience, including experience in audits and inspections

• Clear demonstration of strong negotiation and influencing skills that lead to change

• In-depth knowledge of key interfacing organizations (finance, development, supply chain, regulatory etc.)

• Business-fluent English

• Knowledge and/or experience working with groups across multiple countries and of varied cultural backgrounds

• Demonstrate 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.

*LI-CH1

Category Medical Affairs - USA

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans