Current jobs related to Clinical Operations Director - Princeton, New Jersey - Sun Pharmaceutical Industries, Inc.

  • Clinical Scientist Director

    2 weeks ago

    Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a global biopharmaceutical company that is dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Clinical Scientist Director to join our team.Job SummaryThe Clinical Scientist Director will be responsible for leading and managing a team of...

  • Clinical Data Director

    2 weeks ago

    Princeton, New Jersey, United States Novocure Inc Full time

    Job SummaryThe Director, Clinical Data and Systems is responsible for overseeing Data Management services from clinical study initiation through closure, for the Global Clinical Operations portfolio of studies, in accordance with applicable Standard Operating Procedures (SOPs), federal and local regulations, and ICH-GCP guidelines.The Director liaises with...

  • Clinical Services Manager

    2 weeks ago

    Princeton, New Jersey, United States WCG Clinical Full time

    About WCG ClinicalWCG Clinical is a leading provider of clinical solutions, built on a foundation of best-in-class clinical services companies. We deliver transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those performing clinical trials.Job SummaryThe Manager, Clinician Services is responsible for managing the...

  • Clinical Services Manager

    1 week ago

    Princeton, New Jersey, United States WCG Clinical Full time

    About WCG ClinicalWCG Clinical is a leading provider of clinical solutions, built on a foundation of best-in-class clinical services companies. We deliver transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those performing clinical trials.Job SummaryThe Manager, Clinician Services is responsible for managing the...

  • Clinical Development Director

    4 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job Title: Director, Clinical DevelopmentSun Pharmaceutical Industries, Inc. is a leading global pharmaceutical company with a strong presence in the market. We are seeking a highly skilled and experienced Director, Clinical Development to join our team in Princeton, NJ.Job Summary:The Director, Clinical Development will be responsible for leading the...

  • Executive Director Clinical Development and Quality Operations Lead

    2 weeks ago

    Princeton, New Jersey, United States CLevelCrossing Full time

    Job Title: Executive Director Clinical Development and Quality OperationsAt Bristol Myers Squibb, we are driven by a passion for transforming patients' lives through science.We are seeking an experienced Executive Director to lead our Clinical Development and Quality Operations team. This critical management position will be responsible for developing and...

  • Clinical Development Director

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    About the Role:Sun Pharmaceutical Industries, Inc. is seeking an experienced Clinical Development Director to join its team in Princeton, NJ. As a key member of the Clinical Development organization, you will be responsible for leading the development of clinical trials and ensuring compliance with regulatory requirements.Key Responsibilities:Develop and...

  • Associate Director, Global Clinical Drug Supply Operations

    4 weeks ago

    Princeton, New Jersey, United States Genmab AS Full time

    About the RoleWe are seeking an experienced Associate Director to join our Global Clinical Drug Supply Operations team in Copenhagen or Princeton. As a key member of our team, you will be responsible for driving the strategic direction and development of our department, ensuring compliance and support for drug supply planning.Key Responsibilities:Develop...

  • Senior Director, Clinical Scientist, Oncology

    4 weeks ago

    Princeton, New Jersey, United States PMV Pharmaceuticals, Inc. Full time

    Job Title: Senior Director, Clinical Scientist, OncologyAt PMV Pharmaceuticals, Inc., we are seeking a highly skilled and experienced Senior Director, Clinical Scientist, Oncology to lead our clinical development efforts in oncology. This is a critical role that will play a key part in shaping the future of our company.Key Responsibilities:Lead the...

  • Clinical Services Director

    2 weeks ago

    Princeton, New Jersey, United States Penndel Mental Health Center Full time

    Job DescriptionWe are seeking a dedicated leader to oversee our Family Based Services program. As a Clinical Services Director, you will be responsible for supervising clinicians working with children and families diagnosed with mental illness. The ideal candidate will have a Master's degree and experience working with individuals with mental health...

  • Clinical Operations Manager

    4 weeks ago

    Princeton, New Jersey, United States iHire Full time

    About this role:Fresenius Medical Care has partnered with iHire to find top talent for this exciting opportunity. As a Clinical Manager, you will play a crucial role in ensuring quality patient care while maintaining clinical operations. You will be part of a close-knit team responsible for delivering unique care plans and providing dialysis treatment to...

  • Director of Financial Operations

    2 weeks ago

    Princeton, New Jersey, United States SNI Companies Full time

    Job SummarySNI Companies is seeking a highly skilled Director of Financial Operations to lead our financial operations team. As a key member of our leadership team, you will be responsible for overseeing the financial management of our multi-million dollar operation, ensuring compliance with all funding sources, and providing accurate and timely financial...

  • Clinical Vendor Management Director

    1 month ago

    Princeton, New Jersey, United States Genmab AS Full time

    About the RoleGenmab is seeking an experienced Associate Director to join our Clinical Vendor Management team. As a key member of our team, you will play a pivotal role in managing relationships with clinical vendors, ensuring efficient and effective trial operations.Key ResponsibilitiesCoordinate sourcing for new trials, ensuring timely and effective trial...

  • Associate Director, Veeva Clinical Engineering

    4 weeks ago

    Princeton, New Jersey, United States Bristol Myers Squibb Full time

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a leading biopharmaceutical company dedicated to transforming patients' lives through science. We are seeking an experienced Associate Director to join our team as a Veeva Clinical Engineering Associate Director.Job SummaryThe successful candidate will be responsible for implementing and...

  • Clinical Development Associate Director

    2 weeks ago

    Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time

    Transforming Patients' Lives through ScienceBristol-Myers Squibb is a global biopharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Clinical Development Associate Director to join our team.The successful candidate will be responsible for coordinating with partner counterparts to...

  • Clinical Data Standards Director

    1 week ago

    Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company that is dedicated to transforming patients' lives through science. We are seeking an experienced Clinical Data Standards Director to join our team and contribute to our mission.The Clinical Data Standards Director will be responsible for leading the...

  • Associate Director, Agile Sourcing, Clinical Services

    3 weeks ago

    Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a global biopharmaceutical company that is dedicated to transforming patients' lives through science. We are seeking an experienced Associate Director, Agile Sourcing, Clinical Services to join our team.About the RoleThe Associate Director, Agile Sourcing, Clinical Services will be...

  • Associate Director, Veeva Clinical Engineering

    2 weeks ago

    Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time

    Transforming Patients' Lives through ScienceBristol Myers Squibb is seeking a highly skilled Associate Director to join our team in Princeton, NJ. As a key member of our Global Development Operations (GDO) function, you will be responsible for implementing and supporting strategic information systems that enable our business.Key Responsibilities:Partner with...

  • Clinical Development Director

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job Title: Assistant Vice President, Clinical Development Group LeadSun Pharmaceutical Industries, Inc. is a leading global pharmaceutical company with a strong presence in the clinical development space. We are seeking an experienced Assistant Vice President, Clinical Development Group Lead to join our team in Princeton, NJ.Key Responsibilities:Provide...

  • Director of Financial Operations

    3 weeks ago

    Princeton, New Jersey, United States SNI Companies Full time

    Job Title: Director of FinanceA leading non-profit organization in Somerset County is seeking a highly skilled Director of Finance to oversee the financial management of its multi-million dollar operation.Key Responsibilities:Develop and maintain proper accounting systems, policies, and internal controls consistent with generally accepted accounting...

Clinical Operations Director

2 months ago

Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time
Job Summary

The Associate Director, Clinical Operations is a key member of the clinical operations team at Sun Pharmaceutical Industries, Inc. This role is responsible for overseeing the operational aspects of clinical trials, including project management, vendor selection, and study start-up activities.

Key Responsibilities
  • Oversee and manage all operational aspects of phase I-IV US-based or global clinical trials.
  • Act as primary point of contact for internal and external teams for planning, conduct, and reporting of assigned trials.
  • Participate in vendor selection process with assigned PMO representative, including 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, including site identification, feasibility, site selection, contract negotiation, and clinical study agreement finalization.
  • Oversee, manage, and assess vendor performance, including timelines and deliverables.
  • Develop team and process for carrying out start-up activities for some sites in the US for faster first patient-in (FPI) in a global or US-only study.
  • Prepare and review budgets for studies managed in-house and review professional fees 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, and assess progress as per pre-set timelines.
  • Coordinate finalization of IP label and requisition, forecasting of IP requirement during the study, and prepare IP requisition.
  • Prepare and review study plans for in-house and outsourced studies, train study team on trial documents, processes, and 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.
  • Oversee maintenance and timely update of Trial Master File (TMF/eTMF) and study folder and timely tracking of study information.
  • Review of study-specific documents, including status reports, site visit reports, and study plans, and other reports, such as protocol deviations, data entry, and SDV status, query status, etc., and ensure quality in the study.
  • Perform co-monitoring and vendor oversight visits to ensure quality of trial conduct.
  • Provide status update to stakeholders as per project requirement.
  • Lead process initiatives and improvements as assigned by the function head.
  • Contribute to development and finalization of key study documents, such as protocol, investigator brochure, informed consent document, case report form, etc.
  • Ensure in-house trial closure after completion of all planned activities and oversee archival of all study documents.
  • Complete assigned trainings and establish, maintain updated personal training file.
Secondary Responsibilities
  • Perform/assist during audit/assessment.
  • Participate in meetings and discussions with CROs and support teams.
  • Contribute to interview process.
  • Contribute to departmental activities, including training, initiatives, and any other activities as assigned by FH.
  • Participate in proposal development and in the bid-defense process under guidance and supervision.
Education and Qualification

Bachelor degree in life sciences.

Experience

7-10 years of clinical trial experience.