Responsibilities Collaborates and works closely with cross-functional teams, including clinical and safety stakeholders, to understand their requirements and build analytical solutions. Performs data cleaning, transformation, and other data engineering activities to ensure data quality, consistency, and compatibility for analyses. Develops and implements data analyses plans to answer questions from clinical and safety teams and stakeholders. Applies analytical and/or statistical techniques to analyze data and generate insights to answer clinical and safety questions. Builds effective and user-friendly dashboards and data visualizations to answer key clinical, safety and regulatory questions. Communicates and shares insights with technical and non-technical cross-functional stakeholders, providing data and insights interpretation and understanding. Contributes to qualitative and quantitative research projects through collaboration with cross-functional teams (Pharmacovigilance, Epidemiology, Biostats, etc.) Demonstrates a passion for learning new tools and technology, conducting regular assessments and performance evaluations of our analytics and data visualization platforms, identifying areas for improvement and implementing/recommending appropriate solutions . Acts as a subject matter expert on analytics and business intelligence, sharing knowledge and best practices with the wider organization and participating in knowledge-sharing sessions. Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner.     Qualification & Experience Bachelor's or Master's (preferred) degree in a relevant field, such as Biostatistics, Analytics, Engineering, or related discipline. Minimum of 5+ years of experience in data analysis, statistical modeling, and/or data visualization, preferably within the biopharma or healthcare industry. Experience applying statistical and analytical techniques to analyze clinical and real-world datasets.  

Responsibilities Design and manage the development of modular, reusable, elegantly designed and maintainable software or solutions that supports the RA organization as well as other Cross Functional strategic initiatives. Participate fit-gap workshops with business providing effort estimates and solutions proposals. Hands on, solution driven, and customer focused. Develop and maintain the code repositories for which you are responsible and respond rapidly to bug reports or security vulnerability issues. Embody and integrate software development best practices into your everyday work and inspire others within the engineering community to emulate these practices. Collaborate extensively with your colleagues across Security, Compliance, Engineering, Project Management, Product Management, Product Service Management and Business Management. Continue support for moving Publishing other RA platforms to the cloud. Ensure delivered solutions adhere to architectural and development standards, best practices, and meet requirements as recommended in the architecture handbook. Ensure designed solutions are aligned with Data and Analytics strategy standards and roadmap. Bring innovations to the solutions and add measurable values to RA Business.   Qualification & Experience University degree in Information Technology, Computer Sciences, Life Sciences or similar.. 10+ years of experience in IT technology development experience, preferably with 5+ years of experience working with Pharma Regulatory affairs (RA) business. Experience working in with RA Publishing business is a plus.  

 Responsibilities Oversee and manage the complete lifecycle of biospecimens collected for early phase clinical studies with minimal supervision. Core Clinical Team member responsible for providing Shipping/sample movement and management including requests, query and inventory reports, follow up active issues with vendors, prepare sample management related reports, review/prepare tracking activities (such as vendor manifests/inventories, tissue/blood match pairing, depleted/non-viable samples, loading documents to Shared Drive folders, etc.). Independently reviews clinical study protocol providing comparison of vendor statement of work and biospecimen relevant sections and feedback with support as needed. Performs routine vendor management responsibilities. Able to request and/or access necessary vendor/system inventory files to perform specimen tracking. Able, under direction, to create biospecimen tracker using various tracking tools (MS Excel, Spotfire, Tableau or Polaris (if applicable)) with support. Able to identify biospecimen related risks with support from risk library. May require support for de novo risks and mitigation strategy proposals. Support Critical to Quality (C2Q) process with guidance, if needed. Exercises judgment within policy and procedure boundaries. Troubleshoots routine problems and understands when appropriate to ask for guidance. May need assistance to help prioritize BOW activities during critical deadlines. Maintain intermediate working knowledge of compound and study related biospecimen requirements. Ensure completion of individual Study Transition Forms     Qualification & Experience Scientific degree (Associates, Bachelors, Masters, or higher), Project management or equivalent experience. Minimum of 2 years academic, biotech, healthcare or pharmaceutical industry experience or equivalent.

Responsibilities Tactical operations resource for clinical teams supporting the imaging strategy and imaging vendor selection. Interacts and liaises with imaging vendor project management teams and external imaging KOLs to enhance the value of the relationship and capabilities to BMS needs; ensuring BMS gets best-in class service from the imaging vendor/KOL on a global level. Interacts with imaging BMS protocol management teams; attends regular protocol related team meetings and responsible for communicating imaging timelines/needs Participates in protocol/imaging document development/review Provides operational guidance to clinical team and sites; clinical team training/education Ensures delivery of image data per pre-defined timelines and specifications Performs risk management and contributes to imaging issue resolution Supports due diligence efforts required to qualify imaging vendor, for participation in both novel and strategic BMS relationships requiring imaging capabilities Partners with the key stakeholders to develop and align BMS imaging standards Ensures program level processes and plans are developed to secure consistency across studies within an imaging paradigm Establishes trust and builds successful relationships with key internal and external stakeholders at all levels Through the use of effective communication practices, clarifies expectations, seeks to understand the needs of others and proactively provides status updates keeping stakeholders informed and up to date Proactively seeks feedback from stakeholders on the performance of self and team, operational processes and ways to optimize relationships Uses effective negotiation skills, diplomacy and tact and leverages those competencies to ensure continuous progress with the imaging vendor thus moving issues to resolution Applies broad business knowledge to ensure that decisions are taken in full context of BMS and the imaging vendor perspectives; ensuring balance between needs of the broader relationship vs. those of an individual team or function Fosters teamwork between BMS functional areas and imaging vendor; creating a team environment based on mutual trust and respect Encourages teams to share knowledge, experiences, best practices, and information on an ongoing basis and actively captures that knowledge for re-use and continuous improvement Willingness to travel (5-10% of time) to build relationships and review onsite capabilities     Qualification & Experience Preferred experience 5 years pharmaceutical and/or CRO project management experience Centralized medical imaging project management experience highly desired Digital Specimen Management (other than medical imaging) experience a plus. Demonstrated experience working with internal and external stakeholders (vendor management). Demonstrated ability to manage multiple protocols/projects simultaneously. Demonstrated ability to analyze and interpret complex problems/data from a variety of sources, and through effective decision-making and planning, deliver superior business results. Knowledge of radiology response criteria used in oncology clinical trials preferred but not required (RECIST, etc.).  

Responsibilities Hands on experience to manage Business Glossary, Technical Metadata, Data Lineage, Data Quality, Data Profiling, Master & Reference Data using tools such as Collibra, Informatica, EBX is a Mandatory skill to be successful in this role. Extensive knowledge of Developing Data Strategy, Process Improvement, Data Management Problem Identification & Validation. Associate director works with senior customers in business, operations & technology to define data management roadmap. Also accountable to chair data council and working groups within the assigned domains. Experience of working on data standards such as CDISC, IDMP, IMDRF, MEDDRA, WHODRUG will be added advantage. Ability to challenge status quo, asking relevant data management questions, effectively summarizing current state, bringing insights, and recommending the directions for target state, developing strong working relationship and influencing variety of stakeholder groups is a must have skill. Experience in performing data maturity assessment by using industry agnostic frameworks such as DCAM. This role reports to Enterprise Data Owner for Drug Development domain. Should have experience in program management including project financials. Demonstrated experience in developing data policy, data management framework, guidelines and standards. Knowledge of data management tools such as Collibra, EBX Tibco, Informatica, or any data quality, data governance and master data tools.   Qualification & Experience 15+ years of overall experience. 8+ relevant years in data management. 5+ in Pharma / Life science. Research & Development domain is preferable. Enterprise Data Management, Data Management Strategy, Data Quality Management, Master & Reference Data Management, Metadata Management, Data Flow / Lineage, Data Governance, Data Stewardship, Customer Management, Program Management, Data Proposal & business value, Project Financials, Communication, Data Literacy, Data Councils, Data maturity Assessment, DAMA, DCAM Hands on experience with data governance, data quality, and master / reference data tools such as Collibra, Informatica Data Quality, Tibco EBX and SQL  

Responsibilities Accountable for maintenance and appropriate application of Data Migration Playbook for relevant projects and initiatives Acts as primary interface with M&A and BD&L Business and IT teams Serves as Single Point of Contact for Technology & System team for M&A and Divestment related topics Functions as subject matter expert for implementation of new software tools including internal resource management and interfacing with other line functions Manages and oversees tasks outsourced to vendors, which are under the responsibility of Technology & System Innovation Mentors Managers/Experts System Operations with complex requests, new working procedures. Proactively identifies opportunities for improvement of PS&PV business processes that are implemented through application of appropriate IT methods. Solicits and anticipates future needs, requirements, and direction for systems for PS&PV Understands complex PS&PV business requirements and identifies innovative IT solutions to achieve overall PS&PV goals. Operational support of the safety database users for complex requirements Leads discussions with vendors to resolve problems and develop solutions. Leads or contributes to projects assigned to Technology & System team Supports other functions within Technology & System team   Qualification & Experience Bachelor's degree in life science or computing subject with at least 7 years’ experience in drug development in safety database administration and support At least 4 years in the discipline of safety data management Experience with ORACLE databases  

Responsibilities Review the request for compounds from scientific teams, deliver accurate quantity, record the data and update the details to relevant stakeholders. Coordinate with cross-functional teams for compound transfer as per project requirements Verification of inward compounds with packing list and enter into the inventory with relevant details Registration, documentation and inventory management of compounds Cross-check the end-to-end process of compound transfer before dispatching. Coordinate logistics of sample shipments to and from CROs, manage customs clearance processes as per the shipment requirements. Conduct regular auditing of existing inventory and report the occurrence if any, to the stakeholders Adhere to SOPs and implement best practices in compound management   Qualification & Experience Masters’ degree in Pharmaceutical science/Chemistry 5 years of experience in compound management in bio-pharma industry Must be well-organized and attention to detail Excellent in communication and inter personal skills Proactive and flexible approach to work Experience in stakeholder management  

Responsibilities Work closely with discovery specialists, disease area scientists and in vitro team members Execute diverse in-vitro cell based and biochemical assays, surrounding different key cellular processes and signal transduction pathways to support drug development studies Conduct statistically supported data analysis, and deliver results in a timely manner to enable informed decision-making Record experimental data and observations on a timely basis in company specified format Prepare, review, and deliver scientific presentations for internal/external use Communicate the status of projects, challenges and results to stakeholders Participate in cross-functional team activities, add value to research projects through creative ideas   Qualification & Experience M.Sc. in biological sciences with 2 – 5 years of experience in drug discovery industry Experience in development of in-vitro assays for diverse diseases especially related to inflammation, immunology, metabolic disorders etc. Good understanding of mechanistic pharmacology, immunology, biochemistry and cell biology  

Responsibilities Responsible for coordination of business relationships with Contract Research Organizations (CROs) for outsourced scientific services, including (but not limited to: Communicate all study requests to CROs and track all study actions in appropriate tools. Track status updates of all on-going study activities and follow up on a regular basis for pending results. Ensure all planned deliverables are met as per agreed timelines. Initiate PO requests and review invoices for payment processing. Coordinate project management activities and internal study efforts for Lead Optimization projects as needed Arrange for compound/sample shipments to CROs and ensure all required documentation for outsourced studies Ensure CRO data storage in respective project folders Update and maintain folders for quotes, POs and shipping documents Present progress and status updates at weekly team meetings Seamless coordination with internal stakeholders/project managers to ensure execution of the study strategy Deliver on special projects/tasks as required     Qualification & Experience Master’s degree in biology/chemistry or related subject 2-5 years of experience in pharma/CRO industry Experience in Early Drug Discovery research/project management Good understanding of discovery and pre-clinical stages of Drug Discovery process Excellent interpersonal and communication skills, written and verbal Highly motivated and flexible, with the ability to adjust to rapidly changing priorities and new projects  

Responsibilities Partner with BMD Biomarker Leads (BML) and biomarker subteam SMEs and contribute to project and study biomarker strategy, co-lead (with BML) the efficient transition of biomarker strategy to biomarker study operational plan for assigned studies Lead clinical biomarker operational study strategy and biomarker study plan implementation in TM clinical studies including providing input and reviews of clinical synopsis, study protocols, and other biomarker study operations documentation. Represent all BMD platforms and modalities in CTT including soluble, cellular, genetics, imaging and digital endpoints. Partner with BMD BML and SME and provide biomarker and operational expertise on all assigned clinical studies e.g. lead the BM setup, sample tracking/reconciliation, assay set up, data flow, vendor set up, biomarker sections of clinical study report and biomarker study closure Effectively engage and partner with BMD subteams and biomarker LF experts to ensure on time internal and external (vendor) biomarker deliverables. Update study and project information in relevant meeting, reports and IT systems Serve as a scientific monitor i.e. assay set up, assay transfer and implementation, and monitor biomarker assays at external service providers in one or more biomarker modalities (e.g. Immunoassay, LC-MS, Flow cytometry, tissues, genetics, digital endpoint and devices, etc.) Lead best practices, process and continuous improvement initiatives and innovations in sample, vendor, data flow and assay monitoring functions Contributes to talent and career development of Biomarker Science and Operations staff locally. In collaboration with the relevant BMD managers, contributes to the hiring/interview/onboarding and mentoring process for new hires in India Utilizes established networks and builds new network connections to bring new knowledge into the BMD department.   Qualification & Experience 7+ years in clinical trials and clinical biomarkers. Scientific and operational knowledge of clinical trials, study set up and operations, clinical sample analysis and managing external service provider (ESP) including central laboratories and/or specialized vendors Broad knowledge of clinical biomarkers including soluble, cellular, tissue, genetics, imaging and digital endpoints/devices. Track record of contributions to complex global early phase clinical trials and biomarker implementation