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Data Study Manager

TekWissen LLC

Paramus, NJ

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JOB DETAILS
SALARY
$58–$62
SKILLS
Acceptance Testing, Best Practices, Biostatistics, Biotech and Pharmaceutical, Case Report Form (CRF), Clinical Data, Clinical Data Interchange Standards Consortium (CDISC), Clinical Data Management, Clinical Information Systems, Clinical Practices/Protocols, Clinical Research, Clinical Trial, Coaching, Communication Skills, Continuous Improvement, Cross-Functional, Data Analysis, Data Cleaning, Data Management, Data Quality, Data Structures, Diversity, Documentation, Documentation Review, Electronic Data Capture (EDC), FDA (Food and Drug Administration), FDA Requirements, GCP (Good Clinical Practices), GMP (Good Manufacturing Practices), Healthcare Quality, ICH Regulations, Industry Standards, Interpersonal Skills, Maintain Compliance, Matrix Management, Medical Writing, Mentoring, Metrics, Multitasking, Organizational Skills, Pharmaceutical Data, Presentation/Verbal Skills, Process Improvement, Quality Control, Quality Monitoring, Reconciliation, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Standard Operating Procedures (SOP), Startup, Statistical Analysis System (SAS), Statistical Programming Languages, Team Lead/Manager, Team Player, Test Plan/Schedule, Testing, Time Management, Validation Testing, Vendor/Supplier Evaluation, Workforce Management, Writing Skills
LOCATION
Paramus, NJ
POSTED
1 day ago
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide.
Job Title: Data Study Manager
Location: Paramus, NJ, 07652
Job Type: Temporary Assignment
Duration: 6 Months
Work Type: Onsite
Shift: Mon-Fri 9.00 AM-5.00 PM
Job Description:
  • The Study Manager in Data Management will be responsible for the planning, coordination, and execution of all data management activities for assigned clinical studies.
  • This role ensures the accuracy, integrity, completeness, and regulatory compliance of clinical trial data from study startup through database lock.
  • The Study Data Manager collaborates with cross-functional teams, including Clinical Operations, Biostatistics, Programming, Medical Monitoring, and external vendors, to support the successful delivery of high-quality clinical data.

Duties and Responsibilities:

  • Lead data management activities for assigned clinical studies in accordance with study timelines, applicable regulations, and company standard operating procedures (SOPs).
  • Develop, review, and maintain study-specific Data Management Plans (DMPs) and other required documentation.
  • Design, review, and validate electronic Case Report Forms (eCRFs) and associated database specifications.
  • Coordinate the development, testing, and implementation of Electronic Data Capture (EDC) systems.
  • Develop and review edit checks, data validation rules, and discrepancy management processes.
  • Monitor data quality by reviewing incoming clinical data, identifying discrepancies, and managing data queries to investigative sites and vendors.
  • Coordinate the reconciliation of external data sources, including central laboratory, imaging, electronic patient-reported outcomes (ePRO), and other third-party data.
  • Perform User Acceptance Testing (UAT) for clinical databases and system enhancements.
  • Track study data management metrics and provide regular status updates to project teams.
  • Collaborate with Clinical Operations, Biostatistics, Statistical Programming, Medical Writing, and external vendors to ensure data readiness for analysis.
  • Lead database lock activities, including data cleaning, reconciliation, documentation review, and final quality control.
  • Ensure compliance with ICH-GCP guidelines, FDA regulations, applicable global regulatory requirements, and company SOPs.
  • Support regulatory inspections and audits by providing required documentation and responses related to data management activities.
  • Contribute to the continuous improvement of data management processes, standards,
  • Support inspection readiness and regulatory submissions
  • Serve as the primary DM representative on cross functional project teams and best practices.

Qualifications:
Education Preferred:
  • BS degree in science related field; equivalent education and/or relevant professional experience may be considered.
Work Experience:
Minimum of 4 years Pharmaceutical industry data management experience.
Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology
Working knowledge of Clinical database applications such as EDC and CTMS. Experience or certification in EDC build is a plus.
Applicable knowledge working with data analysis tools, such as SAS.
Experience with working on Phase I-IV study trials within the pharmaceutical industry
Working knowledge of industry standards, such as the ICH guidelines, CDISC data structures, and FDA guidelines
Excellent organizational skills, time management, and ability to meet established deadlines
Excellent verbal and written skills, good organizational, interpersonal, and team skills
Excellent multi-tasking skills
Ability to work effectively across a matrix organization.
Ability to work independently and collaboratively and ability to manage, coach and mentor junior level clinical data managers
Physical and Mental Requirements:
Ability to multitask
Adapts to change
Maintain composure under pressure
Ability to follow verbal or written instructions and use of effective verbal communications
Adapts change, adjust change and grasps information quickly
Examine and observe details
TekWissen Group is an equal opportunity employer supporting workforce diversity.

About the Company

T

TekWissen LLC

WE THE TEKWISSEN PEOPLE

TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.

To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.

Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.

It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.

Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.



COMPANY SIZE
100 to 499 employees
INDUSTRY
Computer/IT Services
FOUNDED
2009
WEBSITE
http://www.tekwissen.com/