Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
DESCRIPTION:
We seek a Project Support Coordinator t to contribute to our mission to enable customers to make the world healthier, cleaner, and safer. You'll provide support to Clinical Data Management (CDM) project teams by performing various administrative activities.
Runs test data for user acceptance testing during startup and submits for filing
Generates user acceptance testing data files post testing for filing in the eTMF
Completes test logs for filing
Prepares study-specific metrics reports, distributes reports to teams, and files reports in study SharePoint folders
Cleans patient tracker at a set frequency
Performs file reviews of the eTMF using the CDM Mapping Guidance and the Database Modification Matrix
Requests access to the electronic data capture (EDC) environment for CDM users
Creates and maintains study information for CDM teams for all new and released study team members
Submits requests to grant or revoke access to the database and reviews team members’ system accesses
Assists with validation of a client's coding dictionary subscriptions to MedDRA and WHO Drug
Ensures a client has current and valid dictionary subscriptions and files subscription confirmations in a study’s SharePoint folder and eTMF
Performs a quality control review of the content of documents, uploads, and classifies final study documents in PPD's eTMF to final approved status
Assists with customizing, posting, and filing study-specific training materials, including submitting requests for training codes
Generates training completion reports and assists with training compliance verification
Files approved and final versions of CDM documents and any other documents upon Clinical Data Team Lead request to the CDM Project Documentation SharePoint folder
Performs tasks associated with generation of data review utility (DRU) listings for all functions at a frequency specified in a study’s Data Validation Manual
Generates test case report forms or patient data reports from a user acceptance testing environment
Organizes, writes, distributes, and files meeting minutes
Circulates, posts, and files meeting information (materials and attendee list)
Generates applicable reports from various systems (e.g., Clarity) and sends to CDM resource managers
Performs Medidata site creation for CDM stand-alone studies
Participates in patient data report (PDR) quality control review and performs PDR filing and PDR generation processes in Medidata EOS Site Cloud
Qualifications:
Education and Experience:
Bachelor's degree is preferred (Preferred Fields of Study: Pharmacy, Nursing, Medical Technology, Biology or related field)
Clinical-related experience is an advantage
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 4 years).
Knowledge, Skills and Abilities:
Ability to work in a team or independently as required
Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
Strong customer focus
Good time management skills, including flexibility to reprioritize workload to meet changing project timelines
Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations (if required), ICH Good Clinical Practices, and organization/Client SOPs and WPDs/work instructions for all non-clinical/clinical aspects of project implementation, execution and closeout
Good English language and grammar skills and proficient local language skills
Effective oral and written communication skills
Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and learn the required clinical trial systems
Ability to successfully complete CRG training program
Self-motivated, positive attitude and good interpersonal skills