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location: Northbrook, Illinois
job type: Contract
salary: $43.35 - 51.00 per hour
work hours: 9 to 5
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 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 Global Development (GD). This role may contribute as a subject matter expert (SME) to DM process and technical/systems improvement initiatives.
- Demonstrated subject matter expertise in 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 contribute subject matter expertise to support process improvement initiatives.
- Oversees multiple DM vendors and provides training as necessary.
- Participates in study level budget review activities for individual studies.
- 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 FSP/CRO 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.
- Quantitative Dimensions: Describe the measurable areas on which this position has direct or indirect impact. Include areas such as operating budget, sales, cost of goods, number of clients or vendors, number and complexity of clinical studies, etc.
- The Data Science department provides statistical, biometrical and data management/warehousing expertise for all R & D projects and marketed products, encompassing Phase I - IV studies. Qualified DM expertise for clinical studies is a regulatory requirement, and is carried out in accordance with international regulations (ICH, FDA, EMA) and internal Astellas SOPs and working practices.
- The Senior DM can oversee vendor DM activities for anywhere from 5 - 7 outsourced studies of of modertate to high
- The Senior DM can support studies across multiple phases of development (Ph. I - Ph. IV).
- Effective project management skills are necessary 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, Clinical 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.
- Strong 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 groups. Use of Microsoft Office Suite (Word, Excel).
skills: FDA, Phase I, Phase II, Phase iii, Phase iv, CDASH, Clinical Data Management, GCP (Good Clinical Practice), EDC (Electronic Data Capture), ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.