Clinical Programmer 2-Manager

Title: Clinical Programmer 2 - Manager Level (SDTM)
Fully remote position - US Based Candidate.
Duration: 9 months+
Shift Schedule: Morning - US time zone 8 hours/day preferably East Coast
Temp to Perm: Not at this time
Pay: $62.00 - $71.80/hr

Core essential:
1. Minimal Bachelors degree in any field
2. Minimal 5 years experience with Clinical data, SDTM IG, and Pinnacle 21.

Must have skills:
Education: Bachelors or higher degree in science or technology or equivalent combination of education and related work experience
Years of experience: 5+ years for Sr Programming Lead professional experience.
Software Knowledge: SAS macros, programs, SAS or SQL based clinical and operational listings
Vast knowledge of CDISC standards
Listed Tools:
SDTM/SDTM IG
Pinnacle 21
Background: 5 yrs of Consecutive Pharma/Therapeutic Industries Only

Screenings:
1. Basic Background
2. 11 Panel Drug + Fentanyl

Position Summary:
The Clinical Programming Manager is responsible for managing the timely and accurate execution of programming components of clinical trials.
The Manager leads and manages completed projects that involve global tasks, cross functional teams, or outsourcing resources. The role may require providing input to design and analysis, and report the results of clinical trials, including programming rules and mocked T/L/G. In addition, providing all safety claims for new drugs and extension of claims/publication support for our marketed drugs.

Major duties and responsibilities:
Responsible to define case report forms (CRFs) specifications in accordance with SDTM guideline and Client standards and leads the cross functional review and approval process.
Responsible to define external (non CRF) data specifications in accordance with Biometrics standards
Responsible to define data flow and to ensure that study databases meet Client requirements by performing User Acceptance Testing (UAT)
Responsible to perform, supervise and manage day-to-day activities associated with receipt of clinical (CRF and non CRF) and operational (when relevant) data in accordance with study timelines
Responsible to perform data handling activities on an ongoing basis to ensure accuracy, reliability, integrity, consistency and completeness of the data prior to database lock and providing the final data to clinical programming and statistics after database lock.
Responsible to program SAS or SQL based clinical and operational listings and reports
Responsible to follow Clinical Programming processes and perform programming activities related to clinical, external and operational data receipt and reporting to ensure the data meets Client requirements and is reported with highest quality to all stakeholders
Develop positive partnerships with CROs and ensure a high standard of deliverables is maintained
Has a good understanding of SAS macros, programs, reporting tools, infrastructure and has programming skills to develop new features, programs and macros
Serves as the focal point on assigned studies for all local interfaces and preserves a fluent workflow with the other interfacing departments and local procedures and processes.
Supports collaboration, communication, coordination and prioritization within the department working in conjunction with Data Management Lead.
Thorough understanding of Clinical data, SDTM IG and Pinnacle 21

Education and Knowledge Requirements:
Bachelors or higher degree in science or technology or equivalent combination of education and related work experience
5+ years for Sr Programming Lead professional experience.
Strong and effective oral and written communication skills and interpersonal skills
Ability to manage multiple projects independently
Ability to work in a virtual, global and multi-cultural environment High level of SAS software knowledge
Vast knowledge of CDISC standards
Detail oriented