Principal Data Manager, Oncology

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:

The Principal Data Manager acts as a data management lead and represents Data Science as the data management key contact in clinical study team meetings and some extended team discussions. This role is responsible for program level data management activities within a drug development program within Data Science). 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 within the program are executed within the agreed timelines and according to the agreed global standards and processes. The Principal DM has full accountability for the DM deliverables across multiple studies and is responsible for all vendor oversight for outsourced DM activities.

The Principal DM contributes expert level Data Management knowledge and consultation to the clinical program team, as well as to other stakeholders within Development. This role may act as a key contact and lead of DM process and technical/systems improvement initiatives.

Essential Job Responsibilities:

• Very strong subject matter expertise in the Data Management (DM) discipline. Can support multiple studies concurrently with little to no oversight by functional manager.

• Advocates the DM position on technical processes within study team meetings and with GSTATL. Shares DM process knowledge with study team colleagues and some cross functional peers.

• Oversees multiple DM vendors and provides training and subject matter expertise to lower-level DM peers.

• Leads by example by providing data management expertise and input into drug development programs.

• Participates in study level budget review activities for individual studies.

• Provides feedback and suggestions for improvement in DM vendor discussions.

• Acts as a functional DM expert for a specific DM specialty area, such as data standards, Medical Coding, eCOA, data visualization, etc.

• Provides Astellas DM subject matter expertise in process related discussions with vendors.

• Uses metrics and key performance indicators (KPIs) to monitor vendor performance.

• Performs vendor oversight activities across multiple studies. Reviews and gives input in vendor oversight processes. Proactively shares and provides suggestions on how to improve vendor oversight.

• Documents any process related deviations and communicates to functional manager. Triggers discussion or takes immediate action if there are concerns with respect to quality of DM deliverables.

• Contributes to industry level DM related activities through participation in key conferences or related initiatives.

• Strong cross-functional understanding on the impact of data management processes to other stakeholders. Mastery level understanding of DM discipline expected.

• Can translate ICH GCP DM requirements to study team members and cross functional partners.

• Developing a good background in support of specific therapeutic areas and has a good overall understanding of data collection and reporting requirements for specific Therapeutic Areas (TAs).

• May assist the Associate Data Management Director in supporting any due diligence efforts associated with corporate or drug portfolio acquisitions.

• 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 to highlight and discuss deviations to the protocol and specific data values relevant for the analysis/determining subject populations.

Quantitative Dimensions:

• The Principal DM is primarily responsible for overall program level delivery and vendor oversight for anywhere from 5 -- 8 studies of any complexity. The Principal DM may have accountability for specific specialty roles within the DM discipline (e.g., data standards, eCOA, etc.).

• The Principal DM is also responsible for providing leadership and subject matter expertise for key DM related process improvement initiatives globally.

• Monitors key study metrics, to ensure alignment to DS and GD development goals for key drug development projects.

• The Principal DM plays an active project management role in team discussions to ensure that all team members and vendor staff are delivering to the commitments on each study.

Organizational Context:

• 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 under loose supervision of Line Manager.

• No direct reports, but oversees the activities of lower-level data managers and vendor staff assigned to the individual studies within a drug program.

• Closely collaborates with cross-functional study team members (e.g., GDOL, Study Manager, Clinical Programmer, etc.)

• Interacts with GDOL, GSTATL, GMRL and other core and extended drug development project team members.

• Coaches and mentors lower-level data managers and vendor staff as needed for assigned studies and projects.

Qualifications:

Required

• BS/BA degree in a biological science, health-related or computer science field. Combination of data management experience and college courses in a related field may be considered.

• Generally, 8 plus years related experience in pharmaceutical, clinical research or health services industry with a minimum of 6 years' experience as Data Manager, with progressive levels of responsibility.

• Demonstrated expertise in DM, inclusive of all activities from program inception to regulatory submission.

• Proven leadership and subject matter expertise for key DM related global process improvement initiatives.

• Prior inspection and major (vendor) audit experience.

• Solid understanding of data standards (i.e., CDISC).

• Strong cross-functional understanding of processes of data management, clinical programming, biostatistics and clinical, with mastery level expertise expected in the DM discipline.

• 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.

• Thorough knowledge 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).

Preferred

• SCDM Certified Clinical Data Manager (CCDM) preferred.

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

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Category Data Science

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