Data Manager

Profile

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 Data Manager (DM) acts as the Astellas data management lead in cross-functional clinical study team meetings for studies of minimal to moderate complexity. This role is fully accountable for DM and vendor oversight for 2 -- 5 studies, depending on study size and complexity. This includes all aspects of DM deliverables (data standards, eCOA, Medical Coding, database build, external data, etc.) and vendor management/oversight of 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 DM contributes detailed data management knowledge and consultation to the clinical study teams

Essential Job Responsibilities:

Developing subject matter expertise in all aspects of the Data Management (DM) discipline, with ability to oversee studies across multiple phases and increasing complexity over time.

Participates in Study Team and all related meetings for assigned protocols.

Performs vendor oversight for assigned studies. Closely collaborates with DM staff at vendors.

Provides feedback on vendor collaboration and performance.

Develops a strong partnership with vendor Lead Data Managers to ensure study level deliverables are on track.

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

Performs vendor oversight activities at the individual study level. Proactively shares feedback and provides suggestions on how to improve vendor oversight.

May be asked to participate in study level budget review activities for individual studies.

Documents any process related deviations and communicates to functional manager.

Ability to identify data trends and make suggestions based upon these identified trends for specific Therapeutic Areas (TAs) or studies within a TA.

Oversees the creation of detailed data management plans, which serve as input to study planning.

Advises Study Team on Data Management related aspects, seeks clarification on specific study needs, provides status/progress updates and highlights issues found during team data reviews.

May lead or contribute to study 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 Data Manager can independently review and manage all aspects of the clinical trial data for 3 -- 4 simultaneously running small phase 1 or phase 2 studies.

The Data Manager can oversee vendor activities for 3 -- 6 outsourced studies of low to moderate complexity.

Effective project management skills are necessary to ensure compliance to both quality and timeline expectations.

Organizational Context:

Reports to Associate Director/Director Data Management.

Has several peers within Data Science and Development at a similar level

Sits on study level project teams

Independent worker, working with regular direction of Line Manager.

No direct reports

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

Oversees activities of outsourced work, and provides coaching and training to vendor Clinical Data Associates as necessary

Requirements

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, 4 plus years related experience in pharmaceutical, clinical research or health services industry with a minimum of 3 years' experience as Data Manager.

Developing strength and expertise in most aspects of DM, inclusive of all activities from program inception to regulatory submission.

Prior inspection and major (vendor) audit experience helpful.

Strong computer skills, including database management software, reporting tools, medical coding tools, etc.

Experience with EDC 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.

Good 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).

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

Type

Full-time

Location

IL, Northbrook

Category

Data Science

Company info

Astellas Us, LLC
Website : https://www.astellas.com/us/