Project Support Coordinator - CDM

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION :
We seek a Project Support Coordinator t to contribute to our mission to enable customers to make the world healthier, cleaner, and safer. You'll provide 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

Q u a li f i cat ion s :

Ed u c at ion a nd E x pe ri e n c e :

• Bachelor's degree is preferred (Preferred Fields of Study: Pharmacy, Nursing, Medical Technology, Biology or related field)

• Clinical-related experience is an advantage

• P r e v ious e x pe ri e n c e t h a t p ro v i de s t he k no w l edge , s k il l s , a nd ab ili t i e s t o pe r f o rm t h e j ob ( c o mpa r ab le t o 0 t o 4 y ea rs ) .

K no w l edge , S k ills a nd Ab i li t i e s :

• 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