Astellas Pharma Sr./Principal Data Manager in Northbrook, Illinois
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 & Scope:
The Senior Data Manager represents Data Science as the data management contact in clinical study team meetings and some extended team discussions. This role is responsible for study level data management activities of moderate to high complexity within a drug development program for Data Science (DS). This includes all aspects of DM deliverables (data standards, eCOA, Medical Coding, database build, external data, etc.), and overall management/oversight of all data management activities for assigned projects to ensure that studies are executed within the agreed timelines and according to the agreed global standards and processes.
The Senior DM has full accountability for the DM deliverables across multiple studies and is responsible for all vendor oversight for outsourced DM activities. The Senior DM contributes strong Data Management knowledge and consultation to the clinical program team, as well as to other stakeholders within Development. This role may contribute as a subject matter expert (SME) to DM process and technical/systems improvement initiatives.
Essential Job Responsibilities:
Demonstrated subject matter expertise in all aspects of the Data Management (DM) discipline. Ability to support multiple studies concurrently with minimal oversight by functional manager.
Advocates the DM position within study team meetings and coaches vendor staff supporting DM work.
May act as a functional DM expert for a specific DM specialty area, such as data standards, Medical Coding, eCOA, data visualization, etc.
May contribute subject matter expertise to support process improvement initiatives.
Oversees multiple DM vendors and provides training as necessary.
Provides feedback and suggestions for improvement in DM vendor discussions.
Uses metrics and key performance indicators (KPIs) to monitor vendor performance.
Performs vendor oversight activities across multiple studies. Proactively shares and provides suggestions on how to improve vendor oversight with functional manager.
Documents any process related deviations and communicates to functional manager.
May attend or participate in key industry conferences or related initiatives.
Strong cross-functional understanding on the impact of data management processes to other stakeholders.
Has a good understanding of regulatory guidelines and issues (i.e., ICH GCP), and understands the connection to DM deliverables.
Develops a strong partnership with vendor Lead Data Managers to ensure program level deliverables are on track.
Leads the data review meetings with Medical, Clinical, Biostatistics and Programming in support of key reporting events or database lock plans.
The Senior DM can oversee vendor DM activities for anywhere from 5 -- 7 outsourced studies of moderate to high complexity.
The Senior DM can support studies across multiple phases of development (Ph. I -- Ph. IV).
Effective project management skills are vital to ensure compliance to both quality and timeline expectations. The Senior DM has developed a strong project management mindset to enable this.
The Senior DM is also responsible for providing subject matter expertise for DM related process improvement initiatives, as needed.
Monitors key study metrics, to ensure alignment to DS and GD development goals for key drug development projects
The Senior DM is an active contributor to study team discussions to ensure that all team members and vendor staff are delivering to the commitments for each study.
Reports to Associate Director/Director Data Management.
Has several peers within Data Science and Development operations at a similar level
Sits on study level project teams
Independent worker, working with regular interaction and direction of Line Manager.
No direct reports
Closely collaborates with cross-functional study team members (e.g., GDOL, Study Manager, Stats Programmer, etc.)
Interacts with GDOL, GSTATL, GMRL and other core and extended drug development project team members.
Coaches and trains vendor DM staff, as needed.
BS/BA degree in a biological science, health-related or computer science field.
Generally, 6 plus years related experience in pharmaceutical, clinical research or health services industry with a minimum of 4 years' experience as Data Manager, with progressive levels of experience with varying study types and phases.
Demonstrated strength and developed expertise in DM. Regulatory submissions experience very beneficial.
Subject matter expertise for key DM related global process improvement initiatives.
Prior inspection and major (vendor) audit experience preferred.
SCDM Certified Clinical Data Manager (CCDM) preferred.
Developing a good cross-functional understanding of processes of data management, clinical programming, biostatistics and clinical.
Strong computer skills, including database management software, reporting tools, medical coding tools, etc.
Experience with EDC and ePRO systems/devices, including implementation of such systems.
Excellent verbal and written communication skills.
Proven ability to work with and influence individuals across multiple disciplines in international environment.
Proven project management and organizational skills in order to prioritize work for self and others to ensure timelines are met, oversee activities of multiple studies.
Solid understanding of medical terminology.
In-depth knowledge of the drug development and data management processes.
Very good knowledge of international regulations for clinical trials (e.g. GCP) and familiar with CDASH/CDISC standards.
Ability to communicate effectively and maintain effective relationships. Must be able to influence staff in other Astellas groups. Use of Microsoft Office Suite (Word, Excel).
Medical, Dental and Vision insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays, including year-end shutdown
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
Category Data Science
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans