Posted in Other 30+ days ago.
Type: Full Time
This a 6-month assignment with potential to extend. Remote candidates must be US or Canadian based. Candidate will be responsible for supporting CDMS Programming activities as related to building study databases, system reports and configuring other system features. As a Clinical Data Programming Lead, you can also function as a Team Lead for CDMS Programmers, ensuring team delivers to expected quality and timelines and providing technical oversight and training/mentoring.
ICON Government and Public Health Solutions specializes in preclinical through phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with a wide array of research, regulatory, and sponsor services both within the US and around the globe and respond rapidly to global health crises.
Reasonable Accommodation Statement:
To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.
Serves as Team lead to CDMS Programmers, providing training, best practices, support and quality checks on study build and programming; ensure effective resource allocation and workload balancing across assigned team members
Extend technical expertise and mentor team members on an ongoing basis; ensure team achieves productivity and quality targets, perform benchmarking reviews and perform oversight of deliverables using different tools/ techniques and maintain and report relevant metrics. Contributes to training materials on a process, system or technology level. Works with CTD and CDMS. Management on delivery of training courses, instructor-led and on-the-job.
* Participates in study specific database set-up using Medidata Rave.
* Reviews database specification documents created by study teams, such as CRF Specifications and Data Validation Specifications (DVS).
* Creates/Programs edit checks, special actions and derivations as per a DVS.
* Works closely with centralized CDMS Testing Group to ensure all programming issues are resolved in a timely manner and study timelines are met
* Trouble-shoots and solves study building issues and edit check programming issues.
* Set up Coder, IRT, T-SDV, and Rave Safety Gateway integrations.
* Run Screen Review Meetings with sponsors and act as point of contact for all Rave questions.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor s legal duty to furnish information. 41 CFR 60-1.35(c)