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Clinical Programmer with Medidata Rave,Hyderabad

Keywords / Skills : Clinical Programmer with Medidata Rave

7 - 10 years
Posted: 2019-07-17

IT/Computers - Software
Software Engineer/ Programmer
Posted On
17th Jul 2019
Job Description
Key Accountabilities:

• • Active management of the DATA FSP providers in their responsibilities to deliver

• • Quality RAVE database builds on time, on budget and conforming to the Genentech data standards in the Global Library for the applicable RAVE URL

• • Quality Assurance (QA) of the QC documentation and deliverables provided by the DATA FSP providers.

• • Management of the IXRS vendor in the responsibility to deliver the programming responsibilities for IXRS

• • Quality Assurance (QA) of the QC documentation and deliverables provided by the IXRS vendors.

• • Support the hiring of permanent programming staff and on-site consultants, as required.

• • Assists in on-boarding, coaching or mentoring new or less experienced team members, including on-site consultants.

• • Making an engaged contribution to delivery of the Medical Team goals.

• • Contribution to the DATA Group Meetings and Data Solutions Meetings and making an engaged contribution towards the delivery of DATA Group Functional goals.

• • Development of Personal Development Plan and commitment to ensuring it’s completion.

• • Being compliant with all applicable training, SOPs and Policies impacting the work of Genentech colleagues, in general, and USMA and Data Solutions, in particular.

• • When required, updating data core business management systems (eg Plansource, CTMS, budget management systems) with quality data, on time.

• • Timely submission of business expenses into the core expense management systems (Concur) for review.

• • Working with Administrative Associate colleagues, as required, to manage personal business travel.

• • Working collaboratively with programming colleagues in other divisions, including gRed, pRed, PD and PDMA.

• • When required, contributing to one or more major cross-functional (within EG) or cross-USMA initiatives.

• • When required, deputize for the Head of DATA Solutions at Senior Meetings such as the Evidence Generation Leadership Team or MLT.

• • As required, give presentations at senior management fora on the status of key projects or initiatives.

• • Provide oversight role for vendors (FSP vendors and external consultant organizations) working on projects.

• • Work collaboratively with the Data Management Therapeutic Area DMs (Oncology and Non-Oncology)

• • Work collaboratively with colleagues in other USMA Medical Units (for instance, Knowledge Enhancement, US Drug Safety, RWD)

• • Support Head of Data Solutions in ongoing resource estimations (headcount and spend), especially Annual resource estimations.

• • Staying abreast of internal and external developments (scientific, clinical, medical, commercial, competitive, legal, regulatory et al) which may impact the portfolio of programming work.

Key Competencies / Experiences for a Clinical Programmer with Medidata Rave experience:

• • At least 5 years of hands on experience in RAVE programming (database creation)

• • Proven proficiency in understanding the CDISC Clinical Data Standards (CDASH and SDTM). Ideally, this will include 2 years’ experience of working with SDTM datasets.

• • At least 2 years’ SAS programming experience.

• • At least 1 years ‘experience of working with Secure FTP tools (Valicert or b2b)

• • Excellent problem solving and analytical skills.

• • Excellent presentation skills – both technical and non-technical presentations.

• • Excellent verbal and written communication skills.

• • Excellent collaborative and team-working skills, as demonstrated by working collaboratively with colleagues in other technical disciplines or at other geographical locations.

• • Proven competence of development of software under a Software Development Lifecycle (SDLC).

Compliance, Audit and Quality Assurance for a Clinical Programmer with Medidata Rave experience:

• Ensuring personal compliance to all applicable SOPs, Policies and Compliance documentation.

• Keeping personal Training and training records up to date.

• Keeping Development Plan updated.

• Delivering programming components of internal audits (for instance, PDQA) and external audits (includes FDA and EMA Audits)

• Managing the level of Quality Control (QC) conducted by external vendors (specifically, FSP vendors) and managing QA of the programming deliverables and QC documentation, once it arrives into Evidence Generation

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