In this role the Business Analyst understands existing dynamics, situations, and pain points in the Pharmaceutical / Life Sciences / Biotech / Device industries from a business perspective (NOT Informatics / IT), including Regulatory, Clinical Repositories, Clinical Operations, Clinical Data Reporting, Dashboards, Metrics, Analytics, and Trial Management Reporting. Supports the creation of roadmaps for customers.
Participate in Requirements Gathering activities as part of the SDLC across the various functional areas within the Product (EDC, Data Management, Biostats. Reporting & Analytics, Medical Data Review, Drug Safety, Operations & Metrics, Content Management, Documentation, Regulatory, Submission) etc on behalf of customers
Understand the current trends and future priorities within the industry to use as a baseline for business requirements, Ensure business requirements fit together horizontally across the E2E business functions within the product, Ensure business requirements are effectively communicated and reach the correct audience (Management, Customers, Development, Validation, Quality etc), Liaise as needed with QA and Product Strategy in particular the teams under Product Strategy (Development, Testing, Implementation, Production Support, Application Support), Support User Acceptance Test (UAT) activities to ensure that product delivery by the Development Team meets the customers needs, Supports operational delivery and service support as needed, Work with the Quality group to ensure that the enhanced Product fits into the overall MaxisIT Business Processes
Education Level:
Bachelors Degree required in Life Science, Informatics, Business or equivalent Preference for formal process training (i.e. PMP)
At least five (5) years of HANDS-ON BUSINESS / Business Analysis experience working as an FTE in the Pharma / Life Science / Biotech Space. a. This is a must no junior resources, b. experience must be in the industry itself (not as a vendor, system integrator, contractor, consultant etc)
At least five (5) years of SUCCESSFUL project implementation experience (prefer 7-8 years) across AT LEAST 2 of the following domains from a detailed business perspective in the Pharma / Health Care space
Content Management
Clinical Data Management
EDC
Metadata & Standards
Reporting & Analytics
Biostats
RBM (1 year experience OK here)
Translational Medicine (1-2 years experience OK here)
Adaptive Trials (1-2 years experience OK here)
Drug Safety
Clinical Operations / Metrics
Non-Clinical / Health Care
Regulatory Affairs
Medical Affairs
Clinical Data Repository / Clinical Data Warehouse
Excellent Communication Skills A MUST across customer, business, and Technical landscape
Experience in a direct customer-facing role (could have actually served as a customer in a previous life)
Proficient knowledge of Clinical Trial phases (I IV)
Strong systems and requirements analysis
Customer and Service Management focus
Virtual team/ Global experience
Multicultural and International experience and scope
Understanding of GxP, CSV and regulations such as 21 CFR Part 11
Knowledge of industry standards e.g. CDISC, HL7 etc. and applications
Knowledge of and practical experience of designing clinical data warehouses/repositories / analytics solutions for the pharmaceutical or healthcare industry.
Change Management Experience
Proficient knowledge and use of Microsoft Office including Word, Excel, PowerPoint, Visio, and Outlook
Ability to communicate effectively with Business and Technical staff
ClinAsia Labs Pvt.Ltd is the closely-held affiliation of MaxisIT Inc. (NJ, USA organization). MaxisIT has been in business for over 11 years serving primarily to Pharmaceutical and Life Sciences industry companies in the areas of clinical trial management, clinical data management, biostatistics, regulatory documents and submission management and Pharmacovigilance utilizing its organically grown integrated suite of software . ClinAsia Labs Pvt. Ltd. was established 8 year's back in India with an objective of building a global full service contract research organization offering integrated software platform based clinical research and allied services to global organizations, combining extreme focus on software-driven consistent Quality and built-in process level Compliance to global regulatory standard (including ICHGCP, ICMR, EMEA and FDA Standards). ClinAsia has wide range of experience working with top pharmaceutical companies located across different geographic regions of the world on therapeutic areas of Infectious diseases, Neurology, Diabetes, Oncology, Gynecology, Endocrinology, Respiratory, Rheumatology, Dermatology, Immunology and Vaccines. ClinAsia has it's headquarter offices at India and United States and satellite offices at Canada, Europe and Singapore. ClinAsia, with its globally integrated clinical research platform based services based in emerging region, brings Asian advantage and global reach to the table. ClinAsia is uniquely positioned as an electronic clinical research organization that provides full scale of clinical research and allied services to Pharma, Biotech, Medical devices companies as well as other CROs globally via its completely integrated clinical development infrastructure that is technology enabled and guarantees efficiency, consistent quality, regulatory compliance, global reach, and of course the cost arbitrage of low-cost delivery region. We are ISO 9001:2008 certified, ensuring the quality standards of Documentation and Training in the organization, ISO 27001 in terms of security and services respectively. All our products are 21 CFR Part11 regulatory complaint and all our projects are executed as per ICH-GCP guidelines
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