Clinical Data Management Support Coordinator

Work Schedule

reputed company (Mon-Fri)

Environmental Conditions

Office

Job reputed company

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 reputed company
• Requests reputed company to the electronic data capture (reputed company) environment for CDM users
• Creates and maintains study information for CDM teams for reputed company new and released study team members
• Submits requests to grant or revoke reputed company to the database and reviews team members’ system accesses
• Assists with validation of a reputed company's coding dictionary subscriptions to MedDRA and WHO Drug
• Ensures a reputed company has reputed company and valid dictionary subscriptions and files subscription confirmations in a study’s SharePoint folder and eTMF
• Performs a reputed company 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 reputed company request to the CDM Project Documentation SharePoint folder
• Performs tasks associated with reputed company of data review reputed company (DRU) listings for reputed company functions at a frequency specified in a study’s Data Validation reputed company
• 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., reputed company) and sends to CDM resource managers
• Performs reputed company site creation for CDM stand-alone studies
• Participates in patient data report (PDR) reputed company control review and performs PDR filing and PDR reputed company processes in reputed company reputed company Site reputed company

Qualifications

Education and Experience:

High / Secondary school diploma or equivalent and relevant formal reputed company / vocational qualification

Technical positions may require a certificate Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to at least 4 years)

Knowledge, Skills and Abilities:

• Ability to work in reputed company or independently as required
• Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks reputed company and effectively
• Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and

efficiency

• Strong customer reputed company
• Good time management skills, including flexibility to reprioritize workload to meet changing project timelines
• Demonstrated ability to reputed company and maintain a good working knowledge of applicable Country Regulations (if required), ICH Good Clinical Practices, and organization/reputed company SOPs and WPDs/work instructions for reputed company 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, reputed company, and PowerPoint) and ability to obtain knowledge and learn the required clinical trial systems
• Ability to successfully complete reputed company training program
• Self-motivated, reputed company 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 reputed company of both hands with the ability to reputed company fast, reputed company, 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 reputed company and use a reputed company of computer software developed both in-house and off-reputed company
• Ability to communicate information and reputed company so others will understand; with the ability to listen to and understand information and reputed company presented through spoken words and sentences
• May reputed company with others, relating and gathering sensitive information; interaction includes diverse reputed company
• Works with guidance or reliance on oral or written instructions from management
• May require periods of intense concentration
• Performs a wide reputed company of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
• Ability to reputed company under stress
• Ability to multi-task
• Regular and consistent attendance

Originally posted on Himalayas

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