Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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