Clinical Data Management Support Coordinator

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