Jobs
>
Princeton

    Associate Director, Clinical Operations - Princeton, United States - Sun Pharmaceutical Industries

    Sun Pharmaceutical Industries
    Sun Pharmaceutical Industries Princeton, United States

    1 day ago

    Default job background
    Description
    Associate Director, Clinical Operations

    Sun Pharma Advanced Research Company Limited Princeton, New Jersey

    Summary

    The Associate Director, Clinical Operations is responsible for Oversight of the Project Management team, Clinical Research Associates, Clinical Trial Associates as well as motivating, mentoring and training. This is a hybrid role and based in Princeton, New Jersey

    Responsibilities Assigned:
    • 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 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.
    • Oversee maintenance and timely update of Trial Master File (TMF/eTMF) & Study folder and timely tracking of study information.
    • Review of study specific documents including status reports, site visit reports & study plans and other reports i.e. Protocol Deviations, Data entry & 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 & finalization of key study documents (i.e. protocol, Investigator brochure, informed consent document, case reports form etc.)
    • Ensure in-house trial closure after completion of all planned activities and oversee archival of all study documents.
    • Complete assigned trainings & 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 & 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
  • Klein Hersh

    Director, Clinical Operations

    2 days ago

    Klein Hersh Princeton, United States

    The Director, Clinical Operations will provide operational and implementation expertise to the project teams under the guidance of the Chief Medical Officer. He or she will lead activities associated with the evaluation, initiation, and management of clinical studies ensuring com ...

  • ACADIA Pharmaceuticals Inc.

    Senior Director, Clinical Vendor Management and Operations

    1 day ago

    ACADIA Pharmaceuticals Inc. Princeton, United States

    Please note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average. · The Sr. Director, Vendor Management, DEI & FSP Operations plays a strategic and operational leadership role in delivering cli ...

  • Bristol-Myers Squibb

    Executive Director, Gtm, Ta Head Immunology/cv

    1 week ago

    Bristol-Myers Squibb Princeton, United States

    **Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...

  • WCG

    Manager, Budgets

    2 weeks ago

    WCG Princeton, United States

    **Description and Requirements**: · **ABOUT WCG**:WCG's clinical solutions are 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 ...

  • The Living Room at Princeton

    Clinical Director

    1 week ago

    The Living Room at Princeton Princeton, United States

    **Job description** · **Overview**:The Living Room is a private substance abuse treatment provider offering Partial Hospitalization (PHP), Intensive Outpatient (IOP), and Outpatient (OP) levels of care. The Living Room is a compassion-based model of recovery. We offer our clients ...

  • Lingraphica

    Clinical Engagement Specialist

    1 week ago

    Lingraphica Princeton, United States

    **Company Description** · **Clinical Essential Duties & Responsibilities**: · - Liaise and collaborate with the Consumer Sales Team, as well as other departments to improve customer experience for all our target audiences, with a focus primarily on individuals with communication ...

  • WCG

    Client Engagement Manager

    4 days ago

    WCG Princeton, United States

    **Description and Requirements**: · **ABOUT WCG**: WCG's clinical solutions are 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 clinica ...

  • Novo Nordisk

    Lead Data Scientist

    2 weeks ago

    Novo Nordisk Princeton, United States

    **About the Department*** · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA ...

  • Bristol-Myers Squibb

    Scientist, Translational Pathology

    2 weeks ago

    Bristol-Myers Squibb Princeton, United States

    **Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...

  • WCG

    Business Operations Specialist

    2 weeks ago

    WCG Princeton, United States

    **Description and Requirements**: · **ABOUT WCG**:WCG's clinical solutions are 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 ...

  • Moderna

    Manager, Real-world Evidence Analytics

    1 week ago

    Moderna Princeton, United States

    **The Role**: · Moderna is looking for a Manager, Real-World Evidence Analytics in Princeton, New Jersey. This role involves collaboration across various teams to generate real-world evidence for drug effectiveness and disease insights using diverse data sources such as claims an ...

  • Fox Trail Memory Care Living

    Community Director- Lpn

    1 week ago

    Fox Trail Memory Care Living Princeton, United States

    As the Community Director · - LPN, you will be responsible for overseeing the daily operations of our memory care community. You will work closely with residents, families, and staff to create a warm and inviting environment that promotes independence and dignity for all. · **Des ...

  • Novo Nordisk

    Data Scientist

    4 days ago

    Novo Nordisk Princeton, United States

    **About the Department*** · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA ...

  • Lingraphica

    Clinical Marketing Engagement Specialist

    4 days ago

    Lingraphica Princeton, United States

    **Company Description** · **Essential Duties & Responsibilities** · Outbound responsibilities: · - Works to schedule SLP's for device demos, webinars, and in-services · - Monitors cancellations and works with SLP's on rescheduling of demos · - Collaborates with the Clinical Sales ...

  • Brandywine Living

    Assistant Director of Nursing

    1 week ago

    Brandywine Living Princeton, United States

    Do you want to be part of a _**_TEAM_**_ that changes lives?_ · - "Brandywine has helped me to grow and develop as a Director of Nursing. I have been able to work alongside some of the best people in the industry. It is the team members and the care and services that we provide t ...

  • Abbott Laboratories

    Manager Apoc Service Sales and Operations

    4 days ago

    Abbott Laboratories Princeton, United States

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...

  • Bristol-Myers Squibb

    Associate Director, Drug Development Portfolio

    21 hours ago

    Bristol-Myers Squibb Princeton, United States

    **Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...

  • United Surgical Partners International Inc (USPI)

    Medical Records Representative Part Time

    4 days ago

    United Surgical Partners International Inc (USPI) Princeton, United States Part time

    **Job Summary**: Maintains and reviews the medical records to assure the timely completion and proper authentication of all records. Safeguards the medical records while making them readily accessible at all times. · **Essential duties and responsibilities**: Include the followin ...

  • Integra LifeSciences

    Corporate Communications Manager

    2 weeks ago

    Integra LifeSciences Princeton, United States

    Changing lives. Building Careers. · Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's poss ...

  • Sintetica US

    Executive Admin and Office Manager

    2 weeks ago

    Sintetica US Princeton, United States

    **Executive Admin and Office Manager - Sintetica US** · Sintetica US, Princeton, New Jersey, On site / Flexible · Full-time · employees - Pharmaceutical Manufacturing · **About the job**: · Founded in 1921 and headquartered in Mendrisio (Switzerland), Sintetica's mission is to co ...