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
