Offer summary

Qualifications:

Bachelor's degree in life sciences, health sciences, information technology, or related fields., 5 to 8 years of relevant experience in data management and database support., Fluent in English, both written and verbal., Good problem-solving and communication skills, with knowledge of clinical trial processes..

Key responsibilities:

Lead development and implementation of solutions for EDC tool issues.

Perform post-production changes and quality control of the EDC database.

Act as Subject Matter Expert and point of contact for technical EDC issues.

Manage programming activities, resources, and timelines for clinical studies.

Job description

Job Overview:

Lead the development and implementation of solutions to global technical services issues and concerns regarding EDC tool like Medidata RAVE. Develop/validate Custom datasets and efficiently handle external data and reconciliations. Perform any postproduction changes to the EDC database. Conduct Peer Review/Quality control of study design for assigned projects.

Summary of Responsibilities:

Lead the development and implementation of Clinical solutions to global technical services issues and concerns regarding EDC tools programming.
Complete assigned work utilizing Medidata Rave according to Fortrea SOPs, Work Instructions, and project specific guidelines in accordance with Good Clinical Practices.
Perform any post-production changes to the EDC database ,
With assistance, meet with Data Manager on assigned projects to discuss contractual obligations and timelines.
Act as Subject Matter Expert (SME) and be point of contact for any technical services, issues related to EDC tools .
Serve as Programmer providing programming support for development and maintenance standards datasets.
Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
Exhibit good imparting, analytical skills along with testing, troubleshooting, error fixing, and documentation skills.
Participate in the ongoing review of the processes used to ensure adaptation of best practices.
Conduct Peer Review/Quality control of study design for assigned projects.
Able to work independently and take initiative to accept new challenges in Clinical Programming Applications, also participate in the validation of new or updates to software.
Maintain awareness of new developments in EDC products which may be applied to improve the efficient use of these systems.
Resource forecasting and allocate activities to the team members on the project.
Proactively identify trends, generate reports/metrics, or demonstrate programming processes to sponsors/auditors (if required), assist with the design of ECRFs and other study documents.
And all other duties as needed or assigned

Qualifications (Minimum Required):

University / college degree (life sciences, health sciences, information technology or related subjects preferred).
Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor’s degree.
Fluent in English, both written and verbal.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

5 to 8 years of relevant work experience to include data management and database support.
Good problem-solving skills and a proactive approach.
Good oral and written communication skills.
Basic knowledge of clinical trial process and data management, biometrics, and systems applications to support operations preferred.
Demonstrated ability to work in a team environment.
Demonstrated ability to work independently under supervision.
Proven interpersonal skills.

Physical Demands : Officebased/Remote

Learn more about our EEO & Accommodations request here.

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