Lead Data Management Programmer

OBJECTIVE: 

The purpose of this position is to provide therapeutic area/development phase data management programming expertise and leadership by:Providing access to data capture technologies to meet the requirements of global development programs.Ensuring timely and reliable transfer of clinical study data from external sources to Takeda.Developing, managing and enforcing standards and technologies for the collection, validation, coding and storage of clinical study data to maximize global data integration and inter-program efficiency. Directing the work of external vendors providing data capture technologies and data management programming capabilities to achieve quality, timely, cost-effective study deliverables.

 

ACCOUNTABILITIES:  Represent the data management programming function in support of assigned clinical studies and programs lead from the US or EU.Identify and assess data capture technologies in support of clinical studies/programs.  Define audit plan to assess vendor data management/data capture systems for compliance with regulatory requirements and principles of the software development life cycle.Define and manage Global Standard Database Specifications (GSDB), Project Standard Database Specifications (PSDB), Study Standard Database Specifications (SSDB), SAS dataset shell for SSDB, and annotated CRF. Develop and maintain global standards library (US/EU/JP) using a clinical data management system (e.g. Oracle clinical).Ensure that the clinical study database is completed in accordance with the requirements of the SSDB/PSDB and other applicable elements of the DMP.Define and manage standards for transfer of clinical study data between vendors and from vendors to Takeda.Archive all the clinical study database and associated specifications and documentation.Identify vendor requirements and lead the evaluation/selection of data management, technology and non-CRF vendors. Provide technical direction for vendors supporting studies/programs. Review and approve key data management vendor deliverables.Develop and implement tools to facilitate access and review of clinical study data by non-programmers.Anticipate and communicate resource and quality issues that may impact deliverables or timelines.  Manage resolution and implement solutions. Assess, define and implement new processes, standards and technology.Comply with all applicable regulatory requirements and Takeda standards and procedures.Serve as a spokesperson for DM Programming on major matters regarding policies, plans and objectives.  Serve as a role model and thought leader for DM.  Actively mentor DM Programmers and Senior DM Programmers.Provide on call support after business hours as needed.



EDUCATION, EXPERIENCE AND SKILLS:  BS or MS in Computer Science, or other related field, with minimum 7 years of experience with database programming, software development, or SAS programming in the pharmaceutical/CRO industry.Advanced skills in at least two database programming languages (SQL, P/SQL, SAS) and at least two clinical data management system (Oracle Clinical) including EDC.Advanced knowledge of programming and computing principles, technical expertise with Windows NT and UNIX operating systems, and common software products and technologies used in conjunction with SAS, expertise with office software (Microsoft Office). Advanced understanding of clinical trial documents (protocol, CRF and DMP)Advanced working knowledge of data management processes and data flow in clinical trials.Basic understanding of drug development process.Advanced knowledge of FDA and ICH regulations including 21 CFR Part 11, and FDA Guidance for Computerized Systems Used in Clinical Trials (April 1999), and principles of the software development life cycle.General knowledge of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes.

TRAVEL REQUIREMENTS:Access to transportation to attend various meetings held in proximity to the Takeda offices.Able to fly to various meetings at investigator, vendor or regulatory agency sites.Some international travel may be required.

Submit your resume and start a quality career with Takeda!

 

We are an equal opportunity employer.

www.tpna.com

 

No Phone Calls or Recruiters Please.