Sr. Manager, Clinical Science CoE, Business Analyst
Astellas

Job Info

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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 from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

This position is responsible for the planning and execution of assigned responsibilities within the responsible Clinical Science support function with operational excellence.

The Sr. Manager COE Business Analyst will support across the Clinical Science organization and sit within the CoE team. In this role, the candidate will be responsible for data analytics with the purpose of utilizing data to support delivery of consistent performance metrics/ to guide departmental decision making and areas of process and project prioritization in support of both drug and non-drug project portfolio.

Accountable for effective management of budgets, timelines, and workload (including distribution to support members, where appropriate) for assigned support function.

Essential Job Responsibilities:


* Responsible for business analysis in support of CS portfolio including program and non-program initiatives
* Proactive management of study related operational metrics, dashboards, and operational data requests
* Interface with groups across the CoE including Vendor Management and Technology/Data Enablement to ensure alignment of activities related to data analytics
* Single point of contact from CS to escalate to Business Process and/or System owners any operational data quality issues to facilitate timely and central resolution on behalf of the business
* Support CS Capacity/Headcount management and optimization of current process
* May provide PM related support when required to support departmental initiatives
* Serve as meeting facilitator, drive non drug project portfolio planning and cross-functional follow-up on behalf of Development non-drug project planning committee
* Responsible for supporting oversight of CS vendors by providing project management, data analysis, development of tools and monitoring dashboards for vendor performance, portfolio allocation and budget aspects of projects as required
* Compile and present data to support program cycle times and key metrics to understand vendor and portfolio performance
* Work with stakeholders within CS and cross functionally as required to support various initiatives
* Provide project support as required; participate in relevant meetings, governance related activities to support initiatives of CS CoE
* Assist in key metric analysis / root cause analysis as required on vendor deliverables

Quantitative Dimensions:

Responsible for the preparation and management of functional budgets and resources (where appropriate) and oversight of related components of trial or support function budgets, timelines and resources.

Organizational Context:

Reports to the Associate Director, Clinical Science or above. This position may have direct reports (no more than 2) and provides oversight and direction to team members for deliverables and may provide direct supervision for contract team members.



Qualifications:

Required


* BA/BS degree with at least 7 years of experience (or 5 years direct experience with an advanced degree (MS/PhD/PharmD)) in pharmaceutical drug development, direct clinical trial management experience is strongly desired
* Must have knowledge of clinical trial conduct, including, multi-center, global trials.
* Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
* Requires proven project management skills and leadership ability
* Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
* Fluent in English.
* Minimal (10-15%) travel required

Preferred


* Experience with vendor key performance indicators as required for vendor deliverables
* Experience with data driven metrics to support analysis of study performance/cycle time
* Experience in working cross functionally and with external providers
* Experience with development & implementation of process improvement related initiatives
* Experience with clinical systems (i.e CTMS, TMF, RBM)
* Previous project management experience

Benefits:


* Medical, Dental and Vision Insurance
* Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
* 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

#LI-SS

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

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