Senior Technical Designer (Clinical Data Programmer)

· Bangalore, Karnataka
Employment Type Full Time
Minimum Experience Experienced

#LI-SS

About Novotech

Novotech is the Asia-Pacific CRO designed for biotech, accelerating clinical development via cutting-edge technology to improve patient lives.


Working in a fast-paced and adaptable environment, we strive to set the benchmark for both business and clinical trial performance across all clinical trial phases and therapeutic areas.


Our people are critical in meeting organizational, and client objectives and we place a strong emphasis on creating a collaborative, transparent, and inclusive work environment where everyone is supported to achieve.


About the Opportunity:

The Senior Technical Designer (STD) is responsible for the design of clinical study databases in Electronic Data Capture (EDC) systems for data capture of clinical and third-party data as described by the protocol and study database specifications. The STD acts as Subject Matter Expert regarding clinical database design practices and application of CDISC data convention standards such as CDASH. The STD provides support and mentoring of junior technical design staff members and conducts all activities according to ICH-GCP and GCDMP guidelines, local regulatory requirements and Novotech/Client SOPs.


Responsibilities:

  • The Senior Technical Designer is responsible for the delivery of the design of Study Database (DB) components for data management projects; including eCRFs, Event Schedules, logical Edit Checks and other DB configurations, and to provide mentoring to junior staff and to ensure adherence to quality standards per SOPs and ICH-GCP.
  • Act as primary point of contact for the CRF/DB design for the Study Team and Sponsor (Client).
  • Review, interpret and translate Protocol and Study requirements into high-quality database design specifications and and report risk factors to Study Team members.
  • Undertake peer review of database design specifications and risk factors drafted by junior Technical Designer as required.


Minimum Qualifications & Experience:

  • Graduate in a clinical or life sciences related field. 
  • Relevant experience/qualifications in allied professions may also be considered. 
  • At least seven years’ experience working as a Clinical Data Manager, Clinical Database Technical designer or programmer in a pharmaceutical industry or related role. Experience in designing CRFs in EDC systems and intimate with CDISC data conventions.


Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. 


Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.


We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.


We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.

Thank You

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  • Location
    Bangalore, Karnataka
  • Employment Type
    Full Time
  • Minimum Experience
    Experienced