Clinical - Biostatical Submissions

Job Description

We are Hiring for Clinical – Biostatical Submissions (Domain SME)

Interested folks can share resume on below mail ID:

pallavi.chaughule@tcs.com

Experience: 10 to 15 years only

Location: Delhi/NCR only

JD:

Then this function of Clinical – Standards and Digital Data Flow Leader at Tata Consultancy Services (TCS) Life Sciences (LS) might an excellent opportunity. We are looking for an experienced & inspiring pharma leader with hands-on expertise in Clinical Standards, Digital Data Flow, Metadata Repository, Biometrics and Data Management (EDC, non-CRF), TFLs, SDR, USDM with in-depth insights in needs, challenges and innovative trends in these domains at a global level. Outstanding communciation skills with ability to translate technology in a clear & easy-to-understand language and cross-pharma senior management network are fundamental to this role.

Main responsibilities and duties

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• Contributes in building Product and solutions in Digital Data Flow, along with Product Team by providing Subject Matter expertise and knowledge on Industry Trends.
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• Contributes to build differentiated Product offerings to maximize Sales and increase number of customers on Product.
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• Co-leads the global strategic positioning & roadmap from a business view for Clinical Standards, Digital Data Flow, Metadata Repository, Biometrics e.g. SDTM, ADaM, Regulatory Submission Packages and Data Management (EDC, non-CRF, eDTA), TFLs, SDR, USDM (e.g. STDM, ADaM.)
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• Co-leads the design & development for these solutions from a business view
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• Co-leads thought leaderships and external visibility (e.g. articles, webinars, conferences, cross-industry meetings), initiates advisory boards and represents TCS at consortia (e.g. CDISC)
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• Supports business development team with customer presentations, RFI/RFP requests and go-to-market strategy. Initiates customer leaderships connects and strategic partnerships.
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Qualifications and education

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• Master’s degree in sciences (e.g. biology, biomedical, pharmacist, statistics) or equivalent by expertise. PhD is an advantage
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• At least 6 years of global drug development experience in Digital Data Flow, metadata repository, clinical data standards, biometrics, EDC, eDTA, gained preferably at top-15 pharma companies or clinical research organizations (CROs)
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• Extensive hands-on experience with Digital Data Flow, data collection standards, biostatistical programming, STDM, ADaM, TFL and regulatory submission packages, including innovative tools and strategies for automation.
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• Experience in applying AI in standardization, SDTM, ADaM and TFL generation.
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• Experience in strategy setting for generating EDC build from study protocol, SDR Model, USDM
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• Experience in innovative ways to automate testing and validation
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• Track record of building respect and trust with customers, employees and other internal and external stakeholders and partners.
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• Broad cross-pharma senior management network & preferably cross-industry forum expertise (e.g. CDISC, Transcelerate, IMI)
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• Outstanding communication skills with ability to translate technology in a clear & easy-to-understand language
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• Strong interpersonal skills including negotiation skills, facilitation skills and ability to drive for clarity and results when faced with ambiguity.
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