Summary
The Clinical Project Manager (CPM) leads and manages a multidisciplinary Clinical Trial Team (CTT) or supports the Sr. CPM in planning and executing clinical studies and programs, ensuring adherence to timelines, budget, quality standards, and operational procedures. This role is crucial in coordinating medical writing, statistics, data management, monitoring, drug supply, regulatory, and safety activities, driving the successful delivery of clinical trials.
About the Role
Location: Hyderabad #LI Hybrid
Key Responsibilities:
Project Management: Collaborate with team members and line functions to establish realistic project timelines, escalating issues when necessary. Lead or support a cross-functional CTT in planning and executing clinical studies, ensuring compliance with Novartis Global processes.
Team Leadership: Manage the CTT, overseeing various functions including medical writing, statistics, data management, monitoring, drug supply, regulatory, and safety. Ensure smooth study setup and execution, maintaining high standards of quality and adherence to timelines and budget.
Stakeholder Coordination: Organize investigator meetings and internal study-related meetings. Interact with investigator sites, CRAs, CROs, and vendors to ensure smooth study conduct, resolve protocol deviations, and perform ongoing risk assessments.
Regulatory Compliance: Support the compilation of study regulatory documents for submission to authorities and ethics committees, ensuring alignment with local regulations and Novartis standards.
Monitoring Oversight: Oversee all monitoring activities, including reviewing site visit reports and ensuring quality control in a timely manner.
Commitment to Diversity & Inclusion:
Novartis is dedicated to fostering an inclusive work environment and building diverse teams representative of the communities and patients we serve.
Essential Requirements:
Desirable Requirements:
Why Novartis:
Our mission is to reimagine medicine to improve and extend lives, aspiring to be the most valued and trusted medicines company worldwide. This vision is driven by our passionate associates. Join us in this mission and contribute to a brighter future. Learn more here.
Benefits and Rewards:
For detailed information about our benefits and rewards, refer to the Novartis Life Handbook.
Join our Novartis Network:
If this role doesn't align with your career goals, join our Novartis Network to stay informed about future opportunities.
Division: Operations
Business Unit: CTS
Location: Hyderabad, India
Company / Legal Entity: Novartis Healthcare Private Limited
Functional Area: Research & Development
Job Type: Full-time, Regular
Shift Work: No
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Bilaspur | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
Goa | Panaji |Gujarat :
Ahmedabad | Baroda | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
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Ranchi |Karnataka :
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Ambernath | Amravati | Aurangabad | Jalgaon | Kolhapur | Mumbai | Nagpur | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane |PAN-India :
Panjab :
Punjab :
Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Jaipur | Pilani | Udaipur |Tamil Nadu :
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Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |Uttarakhand :
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Lawrence |Maryland :
Baltimore | Rockville |Massachusetts :
Boston | Cambridge | Medford and Somerville | Rockland |Minnesota :
Minneapolis and St. Paul, Minnesota. |Missouri :
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Chapel Hills | Durham | Morrisville | Raleigh | Scottsdale |Ohio :
Columbus, |Pennsylvania :
Ambler | Philadelphia | Pittsburgh |Puerto Rico :
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Mexico |Tennessee :
Nashville |Texas :
Austin | Dallas | Houston | Richardson |Virginia :
Blacksburg | Charlottesville | Falls Church |Washington :
Pullman | Seattle |WI :
Madison | Wausau |Wisconsin :
Baden-Wurttemberg :
Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen |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 |New South Wales :
Sydney |Queensland :
Queensland |Republic of Western Australia :
Nedlands |Republic of China :
Beijing |Tokiyo :
Osaka | Tokyo |Republic of Colombia :
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Zagreb |Republic of Egypt :
Cairo |United Kingdom :
Salt Lake City | London |Republic of Ireland :
Limerick | Dublin |Republic of Korea :
Seoul |Capital of Netherland :
Amsterdam |Remote :
Switzerland | Remote | Remote - Europe | Remote, USA |Makkah :
Riyadh | Najran | Rabigh | Jeddah | Khulais |Catalonia :
Barcelona |Republic of Thailand :
Bangkok |