Job Description
Lead R&D/Clinical Domain Consultant
The Lead Clinical Research Consultant will collaborate closely with Domain Client Partners to develop and commercialize the R&D service line for Wipro Health. This role is critical in driving sales and delivery related to the Clinical and Regulatory value chain aspects within Life Sciences clients, including Pharma and Medical Device industries. Additionally, this position supports business development and the creation of collateral and thought leadership.
This role requires a passionate professional who can integrate the evolving technology landscape with traditional Clinical Trial scopes to assist clients in optimizing clinical trials for faster market access. The consultant should possess comprehensive knowledge of the end-to-end clinical trial process, including regulatory submission management. Experience with all four phases of pharmaceutical trials and medical device study processes is essential. Furthermore, operational knowledge concerning the strategy, setup, execution, conduct, submission, and closeout of a clinical trial is required.
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Responsibilities / Skills:
• Deep understanding of the clinical trial process and the distinction between Pharma and Medical Devices.
• Ability to engage C-Suite leaders to craft strategies and solutions driving sales and business development.
• Connect clinical business processes with technology-enabled solutions available at Wipro.
• Provide scientific insights and apply statistical methodologies to interpret data.
• Mature understanding of regulatory requirements for trial conduct, adhering to best practices and guidelines (especially US guidelines).
• Lead in developing project requirements for end-to-end clinical data integration using ETL for structured, semi-structured, and unstructured data.
• Knowledge of clinical systems landscapes, including frameworks such as Veeva Vaults, eTMF, CTMS, EDC, etc.
• Collaborate with functional groups during study setup, preparation, and training; manage study risks proactively.
• Serve as the R&D domain lead expert for life sciences (pharma or med device).
• Foster long-term professional relationships with clients and industry leaders.
Required Knowledge and Experience:
• 10+ years in Clinical Research, preferably within a clinical research program.
• 8+ years working at a Pharmaceutical or Medical Device manufacturer.
• Bachelor's degree in Arts/Sciences (BA/BS), with a Master's degree preferred.
• Highly desired management consulting experience.
• Proficiency in MS Suite products.
• Background in EDC and CTMS systems is desirable.
• Familiarity with Cloud technologies (e.g., AWS - S3, SQS, EC2, Lambda, Redshift, RDS).
• General therapeutic area education and training is preferred.
"Expected annual pay for this role ranges from $150,000 to $230,000. Based on the position, the role is also eligible for Wipro's standard benefits including a full range of medical and dental benefits options, disability insurance, paid time off (inclusive of sick leave), other paid and unpaid leave options."
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