• Login / Signup
    • Instagram
    youtube
    Facebook

    Senior/Principal - Study Build Programmer

    Eli Lily
    6-13 years
    Not Disclosed
    Bangalore
    10 Jan. 29, 2025
    Job Description
    Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Senior/Principal - Study Build Programmer
    Location: Bangalore, Karnataka, India
    Category: Research & Development
    Job Type: Full-Time Regular
    Job ID: R-78336

    About Us:

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees worldwide work to discover and bring life-changing medicines to those who need them, improve the understanding and management of diseases, and give back to our communities through philanthropy and volunteerism. We strive to give our best effort in everything we do, and we prioritize people above all else.

    Job Purpose:

    The Senior/Principal Study Build Programmer is responsible for programming and testing clinical trial data collection databases. This role requires in-depth knowledge of data technology, flow, and standards. The Study Build Programmer will collaborate with cross-functional teams, including Clinical Data Management Associates, Clinical Data Associates, and other stakeholders, to deliver standardized data collection methods and validation solutions for global clinical trials.

    Primary Responsibilities:

    Portfolio Delivery:

    • Program and test data collection systems for a trial or set of trials within a program using a data standards library.
    • Ensure data collection systems are delivered accurately, efficiently, and in alignment with study objectives.
    • Provide insights into study-level deliverables such as the Data Management Plan, Project Plan, database, and observed datasets.
    • Support submission, inspection, and regulatory response activities.

    Project Management:

    • Enhance speed, accuracy, and consistency in the development of systems solutions.
    • Track and report metrics for study development timelines and pre- and post-production changes to databases.
    • Partner with Clinical Data Management Associates to deliver the study database in line with business needs, before the first patient visit.
    • Comply with data standard decisions and strategies for the study/program.
    • Apply therapeutic knowledge and an in-depth understanding of the technology used to collect clinical trial data.
    • Ensure alignment with internal, external, and regulatory requirements (e.g., MQA, CSQ, FDA, ICH, GCP, PhRMA, Privacy regulations, etc.).

    Enterprise Leadership:

    • Continuously seek and implement ways to improve processes, reducing study build cycle time and effort.
    • Represent Data and Analytics processes in cross-functional initiatives.
    • Actively participate in shared learning across the Data and Analytics organization.
    • Work to increase the reusability of forms and edits by improving the initial design.
    • Minimize post-production changes and manage the change control process.

    Minimum Qualification Requirements:

    • 6 to 13 years of database programming and system validation experience in clinical trials, pharmaceutical, biotech, CRO, or regulatory agency sectors.
    • Bachelor's degree in Computer Science, Engineering, Medical Field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, Pharmacy, or a related field.

    Additional Preferences:

    • Master’s degree in a relevant field (Informatics, Life Sciences, etc.).
    • Experience with articulating the flow of data (structure and format) from patient to analysis and applying this knowledge to data solutions.
    • Strong knowledge of clinical and drug development processes and the ability to liaise effectively with study team members (e.g., Data Sciences, Statistics, PK, Operations, Medical).
    • Experience in designing and handling eCOA (electronic Clinical Outcome Assessment) data.
    • Familiarity with clinical data tools and technologies.
    • Knowledge of medical terminology and clinical data standards.
    • Society of Clinical Data Management (SCDM) certification is a plus.
    • Project management and vendor management experience.

    Travel Requirements:

    • Domestic and international travel may be required.

    Lilly is an Equal Opportunity Employer:

    Lilly is dedicated to ensuring equal opportunities for all candidates, including individuals with disabilities. If you need accommodation to submit a resume or application, please complete the accommodation request form at Lilly’s workplace accommodation page.

    Lilly does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, veteran status, disability, or any other legally protected status.

    #WeAreLilly

    Latest Jobs

    Quality-Medical Affairs Professional

    Lilly
    Bangalore India

    Medical Writing – Medical Affairs

    Lilly
    Bangalore India

    Quality Medical Reviewer – Medical Affairs Quality

    Lilly
    Bangalore India

    Specialist - Medical Editor

    Lilly
    Bangalore India

    Specialist - Quality Operations (Gqs I)

    Sandoz
    India Remote

    Patient Safety Specialist

    Sandoz
    India Remote

    Global Medical Development Manager

    Sandoz
    India Remote

    Patient Safety Specialist

    Sandoz
    India Remote

    Senior Clinical Research Associate

    Advanced Clinic
    Deerfield United States

    Senior Clinical Data Associate

    Advanced Clinic
    Ahmedabad India

    Pharma Jobs in India

    Andra Pradesh :

    Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Visakhapatnam |

    Assam :

    Dibrugarh | Diburghar | Guwahati |

    Bihar :

    Hajipur | Patna |

    Chhattisgarh :

    Bilaspur | Eot Municipality | Raipur |

    Delhi :

    Delhi | India | New Delhi | PAN-India |

    Goa :

    Goa | Panaji | Verna |

    Gujarat :

    Ahmedabad | Baroda | Bharuch | Gandhinagar | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |

    Haryana :

    Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak |

    Himachal Pradesh :

    Baddi | Solan |

    India :

    Siliguri |

    Jharkhand :

    Ranchi |

    Karnataka :

    B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |

    Kerala :

    Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |

    Madhya Pradesh :

    Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |

    Maharashtra :

    Airoli | Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Kurkumbh | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |

    Odisha :

    Bhubaneswar | Rourkela |

    PAN-India :

    Panjab :

    Pondicherry (Puducherry) :

    Pondicherry (Puducherry) |

    Punjab :

    Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |

    Rajasthan :

    Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |

    Sikkim :

    Rangpo |

    Tamil Nadu :

    Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy |

    Uttar Pradesh :

    Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |

    Uttarakhand :

    Dehradun | Nainital | Rishikesh | Roorkee |

    West Bengal :

    Digha | Kolkata | Mukundapur |

    Pharma Jobs in United States

    Alabama :

    Birmingham |

    Alaska :

    Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |

    Albama :

    Tuscaloosa |

    Arizona :

    Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |

    Arkansas :

    Fort Smith |

    California :

    Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Morgan Hill | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | St. Helena | Stanford | Stanton | Stockton | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |

    Colorado :

    Boulder | Denver | Westminster |

    Connecticut :

    Bridgeport | Bristol | Enfield | Groton | Hartford | Newtown | South Windsor | Stamford | Storrs | West Hartford |

    D.C :

    Washington |

    Delaware :

    Wilmington |

    Florida :

    Boca Raton | Clearwater | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Hollywood | Jacksonville | Maitland | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |

    Georgia :

    Atlanta | Rome |

    Hawaii :

    Hilo | Honolulu |

    Idaho :

    Boise |

    Illinois :

    Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |

    Indiana :

    Bloomington | West Lafayette |

    Kansas :

    Garden city | Kansas City | Lawrence | McPherson |

    Kentucky :

    Edgewood | Ft MItchell | Louisville | Shelbyville |

    Kington :

    Frank Scottile Blvd |

    LA :

    Baton Rouge | Monroe | New Orleans |

    Louisiana :

    Lake Charles | Shreveport |

    Maine :

    Bangor | Brewer |

    Maryland :

    Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro |

    Massachusetts :

    Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |

    Michigan :

    Detroit | Houghton Lake |

    Minnesota :

    Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | St.Paul |

    Missouri :

    Fulton | Milan | St. Louis |

    Nebraska :

    Hebron | Nebraska City |

    Nevada :

    Las Vegas | Tonopah | Tonopsh | Virginia |

    New Hampshire :

    Lebanon | Manchester |

    New Jersey :

    Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |

    New Mexico :

    Farmington | Santa Fe | Tucumcari |

    New York :

    Albany | Biddle | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |

    North Carolina :

    Concord | Lumberton | North Carolina |

    North Caroline :

    Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |

    North Dakota :

    Dickinson |

    northeastern :

    New Hampshire |

    Ohio :

    Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Norwood | Oregoina | oxford | Waynesville |

    Oklahoma :

    Oklahoma City |

    Oregon :

    Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |

    Pennsylvania :

    Ambler | Bethlehem | Collegeville | Harrisburg | Lancaster | Marietta | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Radnor | Sellersville | Southampton | Spring House | West Chester | Wyomissing |

    Portugal :

    Lisbon | Oeiras | Portugal |

    Puerto Rico :

    San Juan |

    Republic of Mexico :

    Mexico |

    South Carolina :

    Charleston |

    Tennessee :

    Memphis | Nashville |

    Texas :

    Abilene | Arlington | Austin | Boerne | Brenham | Bulverde | Carrollton | Cedar Hill | Corpus Christi | Corsicana | Dallas | Denton | El Paso | Fort Worth | Garland | Houston | Lakeway | Longview | Plano | Richardson | San Antonio | Seguin | Tyler | Waco |

    United states :

    fairmont | Georgia | OH | United States |

    United States :

    Hawai | kentucky | Sylmar | Woonsocket |

    Virginia :

    Blacksburg | Charlottesville | Falls Church |

    Washington :

    Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Vancouver |

    WI :

    Madison | Wausau |

    Wisconsin :

    Portage |

    Wyoming :

    Big Piney | Cokeville |

    Pharma Jobs in Germany

    Baden-Wurttemberg :

    Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |

    Bavaria :

    Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |

    Berlin :

    Mitte |

    Brandenburg :

    Berlin |

    Germany :

    Germany | GErmany |

    Hesse :

    Darmstadt | Marburg |

    Hessen :

    Frankfurt | Harveysburg |

    Lower Saxony :

    Gottingen | Hannover | Leipzig |

    Mecklenburg Vorpommern :

    Rostock |

    Munich :

    Bavaria |

    North Rhine Westphalia :

    Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |

    Rhineland Palatinate :

    Ingelheim am Rhein | Mainz |

    Rotherbaum :

    Hamburg |

    Saarland :

    Saarbrucken |

    Saxony Anhalt :

    Halle |

    Schleswig Holstein :

    Kiel |

    Pharma Jobs in Europe

    Belgium :

    Wavre |

    BULGARIA :

    Bulgaria |

    Denmark :

    Copenhagen | Denmark |

    Europe :

    France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |

    Finland :

    Finland |

    Hungary :

    Budapest |

    Istanbul :

    Istanbul | Turkey |

    Norway :

    Norway | NOrway |

    Romania :

    Romania |

    Serbia :

    Belgrade | Serbia |

    Switzerland :

    Basel | Zurich |

    Pharma Jobs in China

    China :

    China | Quarry Bay |

    Hubei :

    Wuhan |

    Liaoning :

    Dalian |

    Republic of China :

    Beijing |

    Shanghai Sai :

    Shanghai Shi |

    Tokiyo :

    Osaka | Tokyo |

    Zhejiang :

    Hangzhou |

    Pharma Jobs in Australia

    Melbourne :

    South Yarra |

    New South Wales :

    Ballina | Sydney |

    Queensland :

    Queensland |

    Remote Australia :

    Remote Australia |

    Republic of Western Australia :

    Nedlands |

    Pharma Jobs in Ireland

    Cork :

    Ringaskiddy |

    County Dublin :

    Swords |

    Dún Laoghaire :

    Dún Laoghaire |

    Republic of Ireland :

    Cork | Dublin | Limerick | Waterford |

    Ulster :

    Donegal |

    Pharma Jobs in Netherland

    Capital of Netherland :

    Amsterdam |

    Netherlands :

    Netherlands |

    Noord Holland :

    Haarlem |

    North Brabant :

    Breda |

    South Holland :

    Leiden |

    Pharma Jobs in United Kingdom

    Antrim :

    Larne |

    Cheshire :

    Runcorn |

    Hertfordshire :

    Welwyn |

    Surrey :

    Pirbright |

    Pharma Jobs in Argentina & Austria & Belgium & Bosnia and Herzegovina & Bulgaria & Canada & Chile & Colombia & Croatia & Czechia & Egypt & England & Estonia & Federated States of Micronesia & Finland & France & Greece & Indonesia & Israel & Italy & Japan & Kazakhstan & Korea & malaysia & Mexico & New Zealand & Peru & Philippines & Poland & Portugal & Remote & Romania & Saudi Arabia & Serbia & Singapore & South Afrcia & South America & Spain & Sweden & Taiwan & Tennessee & Thailand & Turkey & Ukraine & United Arab Emirates & Vietnam

    Buenos Aires :

    Buenos Aires |

    Austria :

    Austria |

    Vienna :

    Vienna |

    Antwerp :

    Heist op den Berg |

    Brussels :

    Brussels |

    Flemish Brabant :

    Zaventem |

    Bosnia and Herzegovina :

    Sarajevo |

    Sofia City :

    Sofia |

    Canada :

    Canada |

    Ontario :

    Uxbridge | Mississauga | North York | Richmond Hill | Renfrew |

    Quebec :

    Montreal |

    Chile :

    Santiago |

    Republic of Colombia :

    Bogota |

    Croatia :

    Croatia |

    Zagreb :

    Zagreb |

    Bohemia :

    Prague |

    Republic of Egypt :

    Cairo |

    Oxfordshire :

    Witney |

    South Yorkshire :

    Sheffield |

    United Kingdom :

    United Kingdom | Harlow | Stirling | Leeds | Salt Lake City | Stevenage | London | Maidenhead | England |

    Estonia :

    Estonia | Tartu |

    Harju County (Maakond) :

    Tallinn |

    Chuuk :

    North Ostrobothnia :

    Oulu |

    Southwest Finland (Varsinais-Suomi) :

    Turku |

    France :

    Lyon | Paris |

    Attica :

    Koropi | Athens |

    Greece :

    Greece |

    East Java :

    Surabaya |

    Jakarta :

    Jakarta |

    Israel :

    Yavne | Tel Aviv | Be'Er Sheva | Netanya | Kfar Saba |

    Italy :

    Italy |

    Lombardy :

    Rho |

    Japan :

    Japan |

    Tokyo :

    Otemachi |

    Kazakhstan :

    Almaty |

    Remote Korea :

    Remote Korea |

    Republic of Korea :

    Seoul |

    Kuala Lumpur :

    Kuala Lumpur |

    Mexico :

    Ciudad de México |

    North Island :

    Auckland |

    Lima Region :

    Lima |

    Cebu Province :

    Cebu City |

    Philippines :

    Manila |

    Mazovia :

    Warsaw |

    Remote :

    Remote - Europe | Remote - South America (Latin Americal) | Remote - Middle East | Remote | Switzerland | Remote, USA | Remote - Africa |

    Bucharest :

    Bucharest |

    Makkah :

    Riyadh | Khulais | Jeddah | Rabigh | King Abdullah Economic City | Najran |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    South Africa | Midrand |

    Brazil :

    Sao paulo | Brazil |

    South America :

    Argentina | Peru |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |