About the role
Your responsibilities include, but are not limited to:
• Contribute to electronic Case Report Form (eCRF) development with a thorough understanding of data to be collected and in alignment with the protocol.
• Support the assessment of new data collection requirements in assigned studies and provide clinical input into the development of new and updated clinical Data Standards (for CRFs as well as 3rd party data collection methodologies) for assigned trials/therapy areas as needed.
• Provide timely information for, and support the setup and finalization of, accurate and high-quality Data Transfer Specification (DTS) documents.
• Help define a timely transfer schedule for rapid data availability and review. Act as facilitator / problem solver between all parties involved (e.g., clinical functions, data operations, vendors) to streamline and accelerate DTS finalization and revision.
• Provide expert input into the Data Quality Plan (DQP) with a focus on clinical checks (e.g., using standard library checks and accounting for study-specific needs) and data risks.
• Conduct regular Clinical Data Reviews (CDR) in consultation with the Clinical Data Analyst and clinical team (e.g. routine review, for DB lock, Interim Analysis, Snapshots etc) and according to the DQP, utilizing visual outputs, listings, and other outputs as appropriate.
• Lead CDR meetings, keep track and file CDR meetings outcomes and actions. Raise and resolve queries related to CDR in the clinical database. Highlight any significant risk, trend, data discrepancies, process deviations at Data Quality Team (DQT) meetings.
• Identify, track and resolve Protocol Deviations (PDs) as per Novartis processes. Detect potential PDs based on regular clinical data review, evaluate non-important PDs, ensure medical review as needed, file monthly PD listing, detect trends and take actions as required.
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
• 3-4 years relevant experience Clinical Trial Design
• 3-4 years relevant Data Review & Reporting
• Diverse educational backgrounds, including scientists with various Life Sciences backgrounds and Health Care Professionals such as Pharmacists, Nurses, Medical doctors, or Dentists.
• relevant experience in areas such as Clinical Data Review,
• relevant experience in Clinical Data Management,
• relevant experience in Pharmacovigilance
• relevant experience in Clinical Project Management.
WHY NOVARTIS
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Division
Biomedical Research
Business Unit
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Punjab :
Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
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Chandler | Kingman | Lake Havasu City | Peridot | Phoenix | Tempe | Tucson | Yuma |California :
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Denver |Connecticut :
Storrs |D.C :
Washington |Florida :
Coral Gables | Gainesville | Jacksonville | Naples | Orlando | Rueil-Malmaison | Tallahassee | Tampa | West Palm Beach |Georgia :
Atlanta |Hawaii :
Honolulu |Illinois :
Abbott Park | Champaign | Chicago | Deerfield | Lombard | Naperville | Round Lake |Indiana :
Bloomington | West Lafayette |Kansas :
Lawrence |LA :
Monroe | New Orleans |Maryland :
Baltimore | Elkridge | Rockville |Massachusetts :
Boston | Cambridge | Medford and Somerville | Rockland |Minnesota :
Minneapolis and St. Paul, Minnesota. |Missouri :
Fulton | St. Louis |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | 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 York :
Biddle | Buffalo | Hicksville | Ithaca | Morningside Heights | New York | Rensselaer | Syracuse |North Carolina :
Concord |North Caroline :
Chapel Hills | Durham | Morrisville | Philippines | Raleigh | Scottsdale |Ohio :
Columbus, |Oregon :
Bend | Corvallis | Eugene | Roseburg | Springfield |Pennsylvania :
Ambler | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | West Chester | Wyomissing |Portugal :
Lisbon |Puerto Rico :
San Juan |Republic of Mexico :
Mexico |Tennessee :
Nashville |Texas :
Austin | Dallas | Houston | Richardson |Virginia :
Blacksburg | Charlottesville | Falls Church |Washington :
Goldendale | Pullman | Seattle |WI :
Madison | Wausau |Wisconsin :
Wyoming :
Cokeville |Baden-Wurttemberg :
Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Hesse :
Marburg |Hessen :
Frankfurt |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Mainz |Rotherbaum :
Hamburg |Saarland :
Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Denmark :
Copenhagen |Hungary :
Budapest |Istanbul :
Turkey |Serbia :
Belgrade |Switzerland :
Basel | Zurich |Hubei :
Wuhan |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |New South Wales :
Sydney |Queensland :
Queensland |Republic of Western Australia :
Nedlands |Quebec :
Montreal |Republic of Colombia :
Bogota |Zagreb :
Zagreb |Republic of Egypt :
Cairo |United Kingdom :
Harlow | London | Salt Lake City |Jakarta :
Jakarta |Republic of Ireland :
Dublin | Limerick |Israel :
Kfar Saba | Netanya | Tel Aviv |Republic of Korea :
Seoul |Capital of Netherland :
Amsterdam |Remote :
Remote | Remote - Europe | Switzerland | Remote, USA |Makkah :
Rabigh | Khulais | Jeddah | Najran | Riyadh |Catalonia :
Barcelona |Republic of Thailand :
Bangkok |