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Data Manager at RTI Research Triangle Institute in parsippany, New Jersey

Posted in Other 12 days ago.

Type: Full Time





Job Description:

RTI-Health
Solutions(RTI-HS) provides scientifically rigorous research and consulting
services to pharmaceutical, biotech and medical device companies. Our research
and consulting services focus on health economics and outcomes research. Our
various practice areas include: Market Access and Outcomes Strategy, Health
Economics, Patient-Centered Outcomes Assessment, Pharmacoepidemiology, Surveys and
Observational Studies, Biostatistics, Clinical Services, and Health Preference
Assessment.

As a result of our
continued business growth, we are seeking a Data Manager, with the
enthusiasm and vision required to play a key role as part of a dynamic and
internationally focused team.

In this role, you
will be responsible for
providing data management support for patient
chart abstraction and prospective
observational studies for health economics and outcomes
research.

You will be expected to work collaboratively with colleagues to develop, evaluate,
validate, implement, and maintain data collection systems and technology
(either internally developed or subcontracted).
You will provide input on data management policies, guidelines and
procedures (SOPs, training manuals, etc.) and complies with standard operating
procedures (SOPs), and represent Data Management in cross functional meetings.

Additionally, you will work with management to develop and expand data
management capabilities.

Responsibilities:

- Develop and
maintain data collection system used for the capture and processing of
data for pharmaceutical HEOR studies
- Perform system testing of data collection systems
- Review data, at
patient level and in aggregate, for incomplete, incorrect or contradictory
data and work with study participants to resolve any data queries
- Analyze and resolve discrepancies in data validation or
other reports
- Produce
project-specific status reports for management and sponsors
- Monitor study metrics
- Work with project teams to review CRFs for data
acquisition and data entry
- Oversee data management subcontractors
- Provide input on project schedules and budgets
- Develop and maintain auditable data management project
documentation
- Establish data and workflow plans

Qualifications:

- Bachelor's level degree in health information
management, clinical, biological, or mathematical sciences or related
field
- 5 years of data management experience in a
professional environment, preferably within a clinical or medical data
environment or pharmaceutical company
- Direct experience working on chart abstraction studies,
prospective observational studies or clinical trials
- Experience managing multiple simultaneous projects
- Knowledge of FDA and EU/EMA regulations with respect to
data quality and data privacy for the conduct of observational and
clinical studies in the US and Europe. Thorough knowledge of the relevant
ICH and GCP guidelines.
- Demonstrated working knowledge of multiple
clinical data management systems and electronic data capture systems
(e.g., Medrio, Qualtrics, etc.)
- Ability to effectively apply knowledge and skills in a
highly organized fashion while adhering to regulatory guidelines, SOPs and
client expectations
- Must be able to set and meet timelines or be able to
recognize and schedule changes in response to project demands
#LI-BM1

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We are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. Further information is available- https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf