Clinical Data Associate

JOB DESCRIPTION

 
We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology – it is all we do – combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking – we guide our client's therapy through the most critical development milestones from the lab to planning their regulatory and clinical strategy. Our ultimate goal? To help patients.
 


 
Position Summary:
 
This position is responsible for coordinating activities associated with the data management process throughout a clinical trial and overall quality and integrity of data input and output.  This position reports to the Head of
Data Management.


 
Essential Functions:
 

  
Reviews clinical study data with EDC systems, generates queries as needed and works with site data entry staff and site Clinical Research Associates (CRAs) to ensure that data collected is accurately reported
  
Drafts data related manuals and plans, including but not limited to the Data Management Plan (DMP), Data Review and Quality Specifications (DRQS), eCRF Completion Guidelines and Data Validation Specification (DVS). Submits manuals and plans to the Data Manager for final review and approval
  
Performs database User Acceptance Testing, including script writing and execution
  
Maintains and tracks monthly clinical research project data metrics to adequately analyze, identify and report data and trends
  
Assists Data Manager with data coding and maintaining appropriate WHODrug and MedDRA licenses
  
Assists Data Manager with data reconciliation, including adverse event (AE), serious adverse event (SAE) and external lab data reconciliation.
  
Assists in performing bi-annual reviews of database users in collaboration with TD2 project managers
  
Represents the Clinical Data Management department in Sponsor meetings, audits and project team meetings
  
Maintains established timelines for assigned projects
  
Works extensively with project leaders, clinical team members and Sponsors in managing their clinical data needs
  
Encourages collaborations and builds working relationships with functional groups that are contributing to the project plan
  
Liaises with clinical, safety and regulatory organizations for coordination of clinical trial activities
  
Assists with writing controlled documents and department training modules related to the Data Management function
  
Participates in training clinical team members
  
Performs other related duties as assigned


 
 
Job Requirements:
 

  
This position requires at least an Associate's degree with preference to degrees in a health science, statistics, or data management field.  Must have at least 3 years of data coordination or data management experience in a biotechnology/pharmaceutical, academic or contract research organization setting.


 
 
Required Specialized/Technical Skills:
 

  
Experience with clinical data management, clinical study database design and implementation and generation of data reports and listings
  
Experience with hands-on management and testing of clinical databases
  
Experience utilizing programs to code medical terms and medications
  
Experience with commercial electronic data capture systems (EDC) such as Medidata Rave and Oracle Inform
  
Strong computer skills with proficiency in Microsoft Office applications
  
Possess strategic thinking, contingency planning and problem-solving skills
  
Strong interpersonal and communication skills, both oral and written
  
Ability to work collaboratively with cross-functional teams
  
Excellent planning and organizational skills
  
Strong knowledge of the clinical drug development process
  
Demonstrated skill with establishing and documenting standard processes by which project tracking data is collected, updated and reported to the project team
 
 
TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran’s status, gender, sexual orientation, gender identity, or gender expression.