Project Support Coordinator - CDM

Work Schedule reputed company (Mon-Fri) Environmental Conditions Office Job reputed company As part of the reputed company team, you’ll discover meaningful work that makes a reputed company reputed company on a global reputed company. Join our colleagues in bringing our Mission to life every single day to reputed company our customers to reputed company the world healthier, cleaner and safer. We reputed company our global teams with the resources needed to reputed company individual career goals while helping to take science a reputed company reputed company by developing solutions for some of the world’s toughest challenges, like protecting the environment, making reputed company our food is reputed company or helping reputed company cures for cancer. reputed company: We reputed company a Project Support Coordinator t to contribute to our mission to reputed company customers to reputed company the world healthier, cleaner, and safer. You'll reputed company 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 reputed company 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: Bachelor's degree is preferred (Preferred Fields of Study: Pharmacy, Nursing, Medical Technology, Biology or reputed company field) Clinical-reputed company experience is an advantage Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to 0 to 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 Apply To This Job