Senior Lead R&D Technologist

2 days ago


Pune, Maharashtra, India ZS Associates Full time
Job Description

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Here you'll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their business. Bring your curiosity for learning, bold ideas, courage and passion to drive life-changing impact to ZS.

ZS Life Science R&D Technologist in Clinical development

ZS life science R&D team partners with client to discover and develop innovative medicines that improve patient's lives. Our work spans across consulting, analytics and technology (services and platforms) projects across the several domains. We have 3500+ zs professional that are delivering R&D programs, $100MM+ invested in R&D data, analytics and technology assets and 100+ clients on R&D programs.

Our Clinical/Drug Development division displays a substantial history of contributing to numerous client projects with significant results in the drug development. The Drug Development R&D Technologists possess a deep understanding of technological solutions for clinical development processes including clinical study design, data management, analytics, and quality risk management platforms and products. They are well-versed in software related to clinical trial protocol design, electronic data capture (EDC), external data capture, data conformance, transformation, analysis, and reporting. Our team is well versed about industry standards such as CDISC, FHIR, OMOP, and their respective usage. Our team specializes in designing bespoke solutions or products implementation for clinical design, data management, and analytics systems.

Our team has deep understanding of EDC tools like Rave, Veeva, InForm, openClinica, clinical data repositories like SAS LSAF, Oracle LSH, eCS elluminate, Metadata Repositories like Nurocor, Sycamore, Formedix, statistical computing environments like Sycamore, Domino, Sas Viya systems, Clinical data review systems, RBQM systems, and more. With experience as solution architects, business analysts, or techno-functional SMEs in GXP compliant validated environments, they guide the creation of solution, data flows and strategies for building clinical development and data management systems. Their offerings encompass technical advisory, consultancy, developing of clinical data platforms and products, system integration, and intelligent automation. Additionally, the team has created innovative tools through advanced technology and data science, aiding numerous clients in expediting the drug development process.

What You'll Do

- You will spearhead the design & implementation of various innovative solutions in the realms of clinical trial, data management, analytics and RBQM.
- As a solution leader, your role will involve strategizing, offering tech consultancy, conducting assessments, and overseeing technology projects as the solution leader.
- You will be engaging with clients to review clinical business processes, determining requirements, establishing user narratives, and delivering solutions that have significant impact.
- You will lead requirements gathering activities and collaborate with product owner to prioritize and groom the backlog to ensure appropriate level of detail is captured at the right time
- You will lead team who review and Author high-level user stories and develop related tasks, acceptance criteria and review test cases
- Your team will work closely with project teams in creating requirement Specifications, requirement traceability metrics , user guides and other project requirement documents
- You will plan and facilitate various requirement gathering, solution meetings and artefacts
- You will work on creating process flows based on client and internal project discussions
- You will work to perform business process modelling, data flow, user experience modeling, and basic solution architecture diagramming
- Your team will act as techno-functional Liaison between client business user and project engineering team to provide correct business context, business rules
- You will work in building a Business Analysis capability, mentoring and upscaling more junior colleagues, and contributing to the growth of a BA community.

What You'll Bring

- Bachelor's degree in engineering / Pharma/ Bioinformatics / Medicine or related disciplines
- Master's degree in business analyst, Engineering or Science preferred.
- 8+ years of experience working within Life Science Domain as solution architect / business analyst / data analyst is required.
- Experience of working in any of Clinical trial design, data management, analytics and RBQM system development, product implementation and Integration like EDC (Rave, Veeva, InForm), Non-EDC(ePRO, LAB,eCOA) , clinical data repository (CDR - SAS LSAF, Oracle LSH, eClinical elluminate ), Metadata Repository (MDR - Nurocor, Sycamore, Formedix) , statistical computing environment (Domino, Sas Viya) system, CTMS, eTMF, CDMS is required.
- Strong verbal and written communication skills with ability to articulate results and issues to internal and client teams
- Experience in driving requirements discussions, workshops and coordinating with internal and external stakeholders, across time zones, during the planning and delivery of technology projects is required
- Experience working in end-to-end Clinical Data Repository implementation with Biometrics space will be preferred.
- Exposure to clinical data standards like CDISC (SDTM, ADaM), FHIR, HL7, USDM is required.
- Experience in building and delivering GxP compliant solutions for large enterprise program is required.
- Exposure to programming language like R, Python and SAS is preferred.

Additional Skills

- Strong client presence and ability to communicate verbally and in writing complex domain concepts to all audiences.

- Significant supervisory, coaching and hands-on project management skills.

- Ability to manage a virtual global team environment that contributes to the overall timely delivery of multiple projects.

- Willingness to travel to other global offices as needed to work with client or other internal project teams.

- In-silico, digital twin, and/or modeling experience.

Perks & Benefits:

ZS offers a comprehensive total rewards package including health and well-being, financial planning, annual leave, personal growth and professional development. Our robust skills development programs, multiple career progression options and internal mobility paths and collaborative culture empowers you to thrive as an individual and global team member.

We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections.

Travel:

Travel is a requirement at ZS for client facing ZSers business needs of your project and client are the priority. While some projects may be local, all client-facing ZSers should be prepared to travel as needed. Travel provides opportunities to strengthen client relationships, gain diverse experiences, and enhance professional growth by working in different environments and cultures.

Considering applying

At ZS, we honor the visible and invisible elements of our identities, personal experiences, and belief systems-the ones that comprise us as individuals, shape who we are, and make us unique. We believe your personal interests, identities, and desire to learn are integral to your success here. We are committed to building a team that reflects a broad variety of backgrounds, perspectives, and experiences. about our inclusion and belonging efforts and the networks ZS supports to assist our ZSers in cultivating community spaces and obtaining the resources they need to thrive.

If you're eager to grow, contribute, and bring your unique self to our work, we encourage you to apply.

ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law.

To complete your application:
Candidates must possess or be able to obtain work authorization for their intended country of employment.An on-line application, including a full set of transcripts (official or unofficial), is required to be considered.

NO AGENCY CALLS, PLEASE.

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