About this role
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description
Project Support Coordinator, CDM Support Coordinator - Project Support Services Provides 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: High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification Technical positions may require a certificate Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 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 Management Role: No management responsibility Working Conditions and Environment: • Work is performed in an office or clinical environment with exposure to electrical office equipment • Occasional drives to site locations; potential occasional travel required
Physical Requirements:
• Frequently stationary for 4-6 hours per day • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists • Occasional mobility required • Occasional crouching, stooping, bending and twisting of upper body and neck • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs • Ability to access and use a variety of computer software developed both in-house and off-the-shelf • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences • May interact with others, relating and gathering sensitive information; interaction includes diverse groups • Works with guidance or reliance on oral or written instructions from management • May require periods of intense concentration • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence • Ability to perform under stress • Ability to multi-task • Regular and consistent attendance