Responsibilities Assigned : Lead pivotal development program(s).Team Mentoring, Motivating, Training and Oversight for a team of Project Managers, Clinical Research Associates (CRAs), Clinical Trial Associates (CTAs).
Oversee and manage all operational aspects of phase I-IV US based or global clinical trialsAct as primary point of contact for internal and external team for planning, conduct, and reporting of assigned trials.
Participate in vendor selection process with assigned PMO representative. This includes proposal development, bid-defense process, and contract review.
Act as primary point of contact from clinical operations for assigned trials.Oversee study start up activities of CROs (e.
g. Site identification, Feasibility, Site selection, Contract negotiation and Clinical Study Agreement finalization, Translations, EC and Regulatory submission, Site initiation etc.
Oversee, manage and assess vendor performance (timelines and deliverables).Develop team and process for carrying out start up (site identification, feasibility, selection, EC submission, contracting and SIV readiness) for some sites in US for a faster FPI in a Global or US only study.
Budgets- prepare / review budgets for studies managed in house and review professional fee and pass through costs for CROs, SMOs, Investigators, and vendors, as applicable.
Support Functional Head in preparation of annual studies budget and department budget.Manage and track study budget, project milestones, and timelines throughout the life of the study and perform contract reconciliation at study end.
Plan study activities and timelines and share with stakeholders, set up tracking tools for assigned trials & assess progress as per pre-set timelines.
Co-ordinate finalization of IP label & requisition. Forecasting of IP requirement during the study and prepare IP requisition.
Prepare / Review study plans for in-house / outsourced studies. Train study team on trial documents, processes & assigned SOPs.
Plan and Facilitate vendor kick-off meetings and Investigator Meetings for study. Meet investigators and key opinion leaders for assigned trials.
Drive subject recruitment for assigned studies and meet predefined timelines.Prepare and implement Quality control plan in assigned studies and ensure that clinical studies (in-house or outsourced) are in compliance with ICH-GCP, SOPs, and applicable regulations.
Coordinate with cross functional groups for required deliverables.
Clinical Project Manager
Team Mentoring, Motivating, Training and Oversight for a team of Project Managers, Clinical Research Associates (CRAs), Clinical Trial Associates (CTAs). Oversee and manage all operational aspects of phase I-IV US based or global clinical trialsAct as primary point of contact for internal and extern...
Senior Director, Commercial Operations
Princeton, New Jersey (HYBRID: 3 days in office; 2 days remote) Summary: A key member of the Commercial Leadership Team, the Senior Director, Commercial Operations leads and manages commercial functions to include sales operations, sales insights and analytics, sales reporting, market insights and a...
AVP, Head of Integrated Delivery Network - Sun Pharmaceutical Industries, Inc.
Head of Integrated Delivery Networks (AVP), Princeton, NJSun is a leading specialty pharmaceutical company dedicated to improving patient outcomes through innovative and high-quality products. Notice to Agency and Search Firm Representatives:Sun Pharmaceuticals (Sun) is not accepting unsolicited res...
Program Manager, PMO
Summary:Program Manager is responsible to support & manage the day-to-day activities for new product launch projects with the objective to successfully commercialize and launch new products for SUN pharma. Notice to Agency and Search Firm Representatives:Sun Pharmaceuticals (Sun) is not accepting un...
Associate Vice President, Clinical Development
Oversee and participate in the design and planning, execution, and management of clinical trials to evaluate the safety and efficacy of investigational products Provide broad drug development and functional knowledge and experience and overall clinical scientific leadership for the clinical portfoli...
Associate Vice President, Clinical Development - Sun Pharmaceutical Industries, Inc.
Oversee and participate in the design and planning, execution, and management of clinical trials to evaluate the safety and efficacy of investigational products Provide broad drug development and functional knowledge and experience and overall clinical scientific leadership for the clinical portfoli...
Senior Manager, Biostatistics
The main responsibilities will include hands on day to day support of one or more clinical studies. Senior Manager, Biostatistics This position reports to the local area Lead within Biostatistics and Data Management (BDM) group at SPARC. The main activities would include review of the Protocols, eCR...
Sr. Director, Clinical Data Management
Foster Collaboration within BDM with Biostatistics and with Statistical Programming to ensure efficiency and high quality of deliverablesWorks collaboratively with clinical project managers, statistical programmers, clinical research associates, and others to meet project deliverables and timelines ...
Sr. Director, Clinical Data Management - Sun Pharmaceutical Industries, Inc.
Foster Collaboration within BDM with Biostatistics and with Statistical Programming to ensure efficiency and high quality of deliverablesWorks collaboratively with clinical project managers, statistical programmers, clinical research associates, and others to meet project deliverables and timelines ...
Senior Manager, Regulatory Affairs
COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE!Hybrid work arrangementMedical, Dental, Vision BenefitsHealth Savings Account (HSA), Flexible Spending Account (FSA) Prescription Drug CoverageTelehealth and Behavior Health ServicesIncome Protection – Short Term and Long Term Disability B...