Specialist, Program and Application Development

Specialist, Program and Application Development

Job contents (responsibilities,tasks, amount of travel)

Clinical trial database set up, include prepare eCRF, create Edit Check, program reports or listings and

perform post production changes including database updates related to data entry screens and edit

checks/listings

 Clinical trial database operations, include manage user accounts and access rights, perform electronic

data imports and exports, provide relevant documentation and data for archiving, Lock/unlock

databases as requested

 Completing database build specifications and creating eCRFs (electronic Case Report Forms) in the EDC

system, with minimalsupervision to meet project deadlines.

 Gathering User Acceptance Testing (UAT) results and making necessary database modifications to

address any identified issues.

 Interface with study teams, including external CROs/Vendors, where applicable, to integrate study

team requirements into all deliverables.

 Participate in extra activities such as evaluation and testing of new systems and help coordinate CDM

Systems technical initiatives. Contribute strategies, innovative and creative solutions to enhance

processes and increase group productivity.

 Contribute to the ongoing development, review, and revisions of Standard Operating Procedures

(SOPs), Work Instructions, Training, and standard DM templates.

General

 Develop, validate, document, and maintain program(s) and applications required to conduct or

support clinical data quality checking and surveillance for clinical trials and/or programs, (e.g DQSP, CQR,

coding checks, SQSP, SDTM checker, SAE/external data reconciliation, required reports, listings or

figures with SAS, R or other programming languages)

 Create, validate, document, and maintain data conversion programs, follow company level standard.

 Run (the developed) tools, programs and macros according to timelines communicated by the

ordering client/role

 Ad hoc programming requests (e.g data format transfer and data pooling per request)

 Contribute to the continuous improvement, re-engineering and implementation of processes, tools,

technologies, conventions, standards, policies, Standard Operating Procedures (SOPs), and Working

Instructions (WIs) as needed

 Works effectively in a mixed environment and uses best practices and knowledge to improve products

or services and to define processes and standards.

 Solves moderate complexity problems based on advanced to sophisticated analytical skills and

complex judgement.

 Accountable for the quality of on-going activities/processes. Receives minimal guidance or works

independently.

 Contribute as team member to DMMI initiatives

 Develop experience and skills in new Comprehensive knowledge of SAS/BASE, SAS/Macro and R.

knowledge of SQL, Python or other programming languages is a plus

 Good Knowledge of EDC (e.g Inform, Medidate Rave, Oracle RDC)

 Comprehensive Knowledge of CDISC in general and comprehension of SDTM and define.xml

 Good Knowledge of regulations and guidance regarding clinical development, the systems used in this

context and data management related aspects of e- submissions

 Good team player works effectively in international teams, and multi-disciplinary groups.

 Excellent accuracy and attention to detail

 Experience in leading low to moderate complexity projects with limited support from the supervisor

Describe your current team? What does the skill sets, strengths and challenges look like?

The individual would be member of the larger DMMIteam in India that consists of Data Quatlity

Analysts,Data Programmers, Data Integration Managers and Coding Experts. This is a team with diverse

technical skillsets that support the overarching data management activities supported by DMMI and led

by the TDM/PDMs.

How can we add diversity to your group? Would you consider diverse candidates with non-direct

experience and transferrable skills?

We would benefit from bringing onboard a very skilled DB developer with Medrio DB development and

with the prospects on developing his/her skills in other DB areas (ie. Rave)

What type of candidate background are you looking for (level of experience, educational

background)?

A minimum of 6 years of clinical programming and/or EDC database development experience from

pharma, biotech, or CRO and a relevant academic degree in life sciences (e.g., data science, computer

science, pharmacy, biology, statistics).

 Demonstrated technical proficiency in a Clinical Data Management Systems (i.e., Medrio, Veeva

CDMS, Medidata Rave, Oracle Inform, etc.).

 At least 4 years of EDC database development experience and at least 2 years of programming

experience, preferably SQL.

 Proficiency in cultivating and sustaining positive collaborative relationships across diverse functional

areas.

 Project management capabilities encompassing effective group presentation, leadership, verbal and

written communication, interpersonal adeptness, and organizational proficiency.

 Desire to learn new processes and technologies.

 Proficiency in multitasking, independent work, and effective communication.

 Well-versed in the drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical

database cleaning procedures, and 21 CFR Part 11.

 Proficiency in English at a professional level, both written and spoken.