AddressWho we are
The opportunity
The Clinical Programming Lead Manager is responsible for managing timely and accurate execution of all start-up activities and milestone deliverables for all assigned clinical trial projects.
Clinical Programming lead manager is responsible for data definition by working with CRO and Third Party Vendors (TPV) to ensure receipt of data in Teva data standard format, generating the database transfer specification (DTS), receiving and processing study related data. This position is also responsible for providing professional expertise and leadership through leading departmental tasks and taking initiatives in improving data management processes with focus on Data Operations activities.
How you’ll spend your day
Essential Duties & Responsibilities:
- Manages multiple projects
- Likely to oversee contingent workers and/or vendors; Likely to provide training/ Mentoring to others
- Ensures accurate set-up of data transfer processing
- Delivers assignments with quality and within timelines
- Provides strong programming support to CDISC based e-submission. Develops, debugs, and enhances SAS/ SQL programs to support to support study data batch processing and oversight listings
- Responsible to define case report forms (CRFs) and external (non CRF) data specifications in accordance with CDISC guideline and Teva standards.
- Responsible to define data flow and additional startup activities related to study initiation
- 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/unblinding 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.
- Supports collaboration, communication, coordination and prioritization within the department working in conjunction with Data Management Lead.
- 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 Teva requirements and is reported with highest quality to all stakeholders
- Pro-actively interacts and collaborates with different teams and provides necessary professional and programming support.
- Participates in development of new SOPs/ Guidelines and Job Aids, as necessary
- Initiates and leads new processes, new methodologies and operational ideas and re-challenges existing ones to improve the services provided, effectiveness, efficiency and faster turn around
- Possible budget planning input
Your experience and qualifications
Position Requirements:
Education Required: Bachelor’s Degree/ Master’s Degree/ PhD in Science, Statistics, Information Technology or equivalent combination of education and related work experience.
Experience Required: Bachelor’s + 5 years or Master’s + 4 years of professional experience in a pharmaceutical or clinical research setting as a programmer
Experience Preferred: Extensive understanding of cross functional deliverables, regulatory requirements
Specialized or Technical Knowledge Licenses, Certifications needed: Thorough understanding of Clinical data, SDTM IG and Pinnacle 21
4+ years of SAS Programming experience
Functional Knowledge:
Comprehensive knowledge of CDMS systems. Exceptional knowledge and subject matter expert in CDISC Data Standards and CRF CDASH standards. Expert in Data Transfer Specification review / authoring. Programming listings and understanding related SAS macros. Authoring cSDRG for submission package and review. Manage study level batch processing and report technical challenges.
Company/Industry Related Knowledge: Intermediate knowledge of government regulations pertaining to drug development in multiple therapeutic areas.
Enjoy a more rewarding choice
We are strengthening and adding to our critical teams with great talent and capabilities: Teva, a global organization with a brand of evolving success. Be part of it!
We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, Paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
