Project Support Coordinator - CDM

Work Schedule

Environmental Conditions

Job 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