Talent.com
Senior Manager, Clinical Data Management
Senior Manager, Clinical Data ManagementBristol-Myers Squibb • Plainsboro, NJ, United States
No se aceptan más aplicaciones
Senior Manager, Clinical Data Management

Senior Manager, Clinical Data Management

Bristol-Myers Squibb • Plainsboro, NJ, United States
Hace 20 días
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

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 line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more : careers.bms.com / working-with-us .

Functional Area Description

Clinical Data Management key focus is to ensure data quality, integrity & completeness of all data types (eCRF and non eCRF) collected in BMS clinical trials from study start to database lock.

Position Summary

The Senior Manager, Clinical Data Management is a leadership role considered essential to the sustainability and success of the BMS R&D pipeline. This role may report into Director, Clinical Data Management or Associate Director, Clinical Data Management

This is an office-based in BMS New Jersey locations.

Position Responsibilities

Responsibilities will include, but are not limited to :

Project Management and Leadership

  • Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects
  • Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects
  • Responsible for end-to-end clinical data management activities and serves as a primary point of contact for internal and external study team members
  • Provides strong quality and project oversight over third party vendor responsible for data management deliverables
  • Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway). Enforces data standard conventions and quality expectations for clinical data per defined processes
  • Authors, reviews / revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization
  • Chairs Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality and completeness
  • Represents DM on cross-functional project teams & submission Teams
  • Lead or support the Health Authority inspections and audits
  • Provides coaching and quality oversight of junior Data Management Leads

FSP / CRO / Vendor Oversight

  • May act as core member of the study team and provides FSP / CRO / Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA)
  • Continuous improvement initiatives

  • Provides the relevant support and input to continuous improvement activities within clinical data management
  • Provides support for CAPA implementation as required
  • Degree / Experience Requirements

  • Bachelor's Degree required with an advanced degree preferred
  • At least 5 years of relevant industry experience. Project management certification (e.g. PMP) is desirable.
  • Key Competency Requirements

  • Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors
  • Sound knowledge of Clinical Drug Development Process, FDA / ICH guidelines and industry standard practices regarding data management
  • Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection
  • Strong project management; Exhibits expertise in metrics analysis and reporting methodologies
  • Excellent oral and written communication skills. Communicate effectively with senior management and cross-functional teams
  • Knowledge of submission requirements, [e.g. New Drug Application (NDA) / Biologics License Application (BLA) / Market Authorization Application (MAA)]
  • Travel Required : 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed)

    If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

    Compensation Overview :

    Madison - Giralda - NJ - US : $143,590 - $173,998

    Princeton - NJ - US : $143,590 - $173,998

    The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

    Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https : / / careers.bms.com / life-at-bms / .

    Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following : Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility / infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

    Uniquely Interesting Work, Life-changing Careers

    With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

    On-site Protocol

    BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role :

    Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

    BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations / adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation / adjustment prior to accepting a job offer. If you require reasonable accommodations / adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com / eeo -accessibility to access our complete Equal Employment Opportunity statement.

    BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

    BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

    If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information : https : / / careers.bms.com / california-residents /

    Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

    Required

    Preferred

    Job Industries

  • Healthcare
  • Crear una alerta de empleo para esta búsqueda

    Manager Clinical Data • Plainsboro, NJ, United States

    Ofertas relacionadas
    Lead Clinical Data Manager

    Lead Clinical Data Manager

    VirtualVocations • Newark, New Jersey, United States
    A tiempo completo
    A company is looking for a Lead Clinical Data Manager (Remote).Key Responsibilities Lead data management for complex, global clinical trials from study setup to database lock Serve as the main c...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Data Management Manager

    Data Management Manager

    VirtualVocations • Hamilton, New Jersey, United States
    A tiempo completo
    A company is looking for a Data Management Manager (Remote).Key Responsibilities Lead a team in data exploration and analysis, translating business rules into technical specifications Manage dat...Mostrar más
    Última actualización: hace 1 día • Oferta promocionada
    Associate Director, Data Management

    Associate Director, Data Management

    VirtualVocations • Hamilton, New Jersey, United States
    A tiempo completo
    A company is looking for an Associate Director, Commercial Data Management.Key Responsibilities Act as a strategic partner and advisor for data acquisition and utilization Oversee master data se...Mostrar más
    Última actualización: hace 4 días • Oferta promocionada
    Senior Manager Clinical Study Lead (Oncology)

    Senior Manager Clinical Study Lead (Oncology)

    Regeneron • Warren, NJ, US
    A tiempo completo
    This role is an onsite position in one of our office locations.The Senior Clinical Study Lead (CSL) is expected to operate with a high degree of independence and is accountable for the global execu...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Certified Oncology Data Manager

    Certified Oncology Data Manager

    VirtualVocations • Newark, New Jersey, United States
    A tiempo completo
    A company is looking for a Manager Oncology and Data Accreditation.Key Responsibilities Ensure compliance with ACS CoC and NAPBC standards at accredited facilities Lead survey preparation and ma...Mostrar más
    Última actualización: hace 3 días • Oferta promocionada
    Director of Clinical Transformation

    Director of Clinical Transformation

    VirtualVocations • Newark, New Jersey, United States
    A tiempo completo
    A company is looking for a Director of Clinical Transformation.Key Responsibilities Manage the development and deployment of clinical transformation programs to improve quality and patient servic...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Clinical Outsourcing Manager

    Clinical Outsourcing Manager

    VirtualVocations • Elizabeth, New Jersey, United States
    A tiempo completo
    A company is looking for a Manager / Senior Manager, Clinical Outsourcing.Key Responsibilities : Assist in developing structures and processes for the Clinical Outsourcing function Negotiate Clinic...Mostrar más
    Última actualización: hace 5 días • Oferta promocionada
    Senior Manager, ML Platform

    Senior Manager, ML Platform

    VirtualVocations • Newark, New Jersey, United States
    A tiempo completo
    Key Responsibilities Mature and deliver a vision for the unification of ML practices across the organization Build systems that support analytics production at scale and own the deployment of ML...Mostrar más
    Última actualización: hace 3 días • Oferta promocionada
    Clinical Data Manager

    Clinical Data Manager

    Pharmaron • Franklin Township, NJ, USA
    A tiempo completo
    Quick Apply
    Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK an...Mostrar más
    Última actualización: hace 4 días
    Senior Associate Study Manager

    Senior Associate Study Manager

    VirtualVocations • Elizabeth, New Jersey, United States
    A tiempo completo
    A company is looking for a Senior Associate Study Manager to support the execution and monitoring of clinical studies.Key Responsibilities Assist in study planning, vendor management, and coordin...Mostrar más
    Última actualización: hace 9 días • Oferta promocionada
    Senior Clinical Trial Manager

    Senior Clinical Trial Manager

    VirtualVocations • Hamilton, New Jersey, United States
    A tiempo completo
    A company is looking for a Senior Clinical Trial Manager.Key Responsibilities Oversee the clinical portion of the budget to ensure efficient resource allocation Develop monitoring plans and tool...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Senior Manager

    Senior Manager

    Katalyst Healthcares & Life Sciences • South Plainfield, NJ, US
    A tiempo completo
    Essential Duties and Responsibilities : Provide guidance to the Transparency team on overall Clinical Trial processes and conduct. Perform required clinical trial registration and / or results disclosu...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Senior Manager, Clinical Trial Transparency

    Senior Manager, Clinical Trial Transparency

    VirtualVocations • Newark, New Jersey, United States
    A tiempo completo
    A company is looking for a Senior Manager, Clinical Trial Transparency & Disclosure (Remote).Key Responsibilities Interact with clients and regulatory authorities, representing the client at key ...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Senior Manager Clinical Study Lead (Cell Therapy)

    Senior Manager Clinical Study Lead (Cell Therapy)

    Regeneron • Warren, NJ, US
    A tiempo completo
    The Senior Clinical Study Lead (CSL) is expected to operate with a high degree of independence and is accountable for the global execution of assigned large and / or complex clinical trials from stud...Mostrar más
    Última actualización: hace 22 días • Oferta promocionada
    Senior Manager Clinical Operations

    Senior Manager Clinical Operations

    VirtualVocations • Hamilton, New Jersey, United States
    A tiempo completo
    A company is looking for a Senior Manager Clinical Operations.Key Responsibilities Drive operational results to achieve quality outcomes and reduce avoidable hospitalizations Manage performance ...Mostrar más
    Última actualización: hace 1 día • Oferta promocionada
    Senior Manager, Clinical Data Management

    Senior Manager, Clinical Data Management

    New Jersey Staffing • Madison, NJ, US
    A tiempo completo
    Senior Manager, Clinical Data Management.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 ...Mostrar más
    Última actualización: hace 3 días • Oferta promocionada
    Prin Clinical Data Manager

    Prin Clinical Data Manager

    Novartis Group Companies • East Hanover, NJ, United States
    A tiempo completo
    Love clinical data management? Bring that passion to Novartis!.This key Principal Clinical Data Scientist will be responsible and accountable for managing all Data Management deliverables at a cons...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Licensed Clinical Services Manager

    Licensed Clinical Services Manager

    VirtualVocations • Elizabeth, New Jersey, United States
    A tiempo completo
    A company is looking for a Clinical Services and Operations Manager.Key Responsibilities Oversee day-to-day operations for all clinical programs, ensuring compliance and performance standards Mo...Mostrar más
    Última actualización: hace 4 días • Oferta promocionada