Clinical Trials Operations Manager

2 weeks ago

Nutley, New Jersey, United States Hackensack Meridian Health Full time

Position Overview:

At Hackensack Meridian Health, our team members are integral to our mission of enhancing patient care and fostering a supportive work environment. We believe in a culture that emphasizes teamwork and collaboration, where competitive benefits are just the beginning of our commitment to each other and our community.

As a Clinical Trials Operations Manager, you will play a crucial role in the coordination and management of clinical operations for various clinical studies. This position involves assessing, planning, and ensuring compliance with all relevant local, federal, and state regulations, as well as institutional policies and standard operating procedures. You will work closely under the guidance of the principal investigator overseeing the assigned clinical trials.

Key Responsibilities:

  • Serve as the primary contact between principal investigators, sub-investigators, clinical research nurses, and regulatory specialists regarding regulatory matters and protocol modifications.
  • Collaborate with the principal investigator and clinical team to evaluate study feasibility and assess potential competition with other protocols prior to submission.
  • Review study budgets with the principal investigator and clinical research nurses, finalizing drafts with the budget coordinator.
  • Analyze proposed study protocols to assess sample collection processes, data management strategies, and potential risks to subjects. Ensure informed consent is obtained and documented appropriately.
  • Coordinate research activities, including scheduling laboratory tests, radiology exams, and other medical assessments as required.
  • Work with the study team to develop study-specific orders, billing templates, and calendars as necessary.
  • Schedule appointments, procedures, or inpatient stays for subjects as dictated by study protocols.
  • Monitor all study activities to ensure adherence to protocols and compliance with all relevant regulations and institutional policies.
  • Register protocol patients with appropriate statistical centers as required.
  • Track subject enrollment status and document dropout information, including reasons for dropout and efforts to contact subjects.
  • Act as a representative for principal investigators as appropriate, including communication with sponsors and other medical personnel.
  • Maintain accurate and up-to-date records for each protocol and patient participating in clinical trials within the clinical trial management system and other required systems.
  • Collaborate with clinical research finance to ensure proper billing for clinical trial-related activities.
  • Coordinate and prepare for sponsor monitor site visits, ensuring all necessary documentation is available and meets requirements.
  • Maintain communication with sponsors to schedule site visits and address questions regarding data completeness.
  • Ensure compliant maintenance of all required study records, including case report forms and regulatory documents.
  • Oversee the requisition, collection, labeling, storage, and shipment of specimens.
  • Participate in quality assurance audits conducted by sponsors or regulatory agencies.
  • Prepare study-related documentation, including protocol worksheets, procedural manuals, and progress reports.
  • Identify and communicate protocol issues to investigators and assist in resolving them.
  • Organize space for study equipment and supplies.
  • Contribute to the development of study protocols and guidelines for data collection procedures.
  • Engage with external healthcare providers and subjects to obtain follow-up information.
  • Stay current with clinical research developments by reviewing scientific literature and participating in educational activities.
  • Collaborate with investigators to prepare presentations or reports on clinical study procedures and outcomes.
  • Attend research meetings and conferences as required.
  • Participate in staff meetings and in-service education as necessary.
  • Perform other duties and projects as assigned.
  • Adhere to organizational competencies and standards of behavior.

Qualifications:

  • Bachelor's degree in a science or healthcare-related field.
  • A minimum of 2 years of experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years of relevant experience in clinical research.
  • Strong attention to detail and a focus on customer service.
  • Ability to work independently or collaboratively in a team, managing multiple deadlines in a dynamic environment.
  • Excellent organizational, presentation, documentation, and interpersonal skills.
  • Proficient written and verbal communication skills.
  • Strong computer skills, including proficiency in Microsoft Office and/or Google Suite.

Preferred Qualifications:

  • Education in human subject research and Good Clinical Practice (GCP).

Licenses and Certifications Preferred:

  • SOCRA-Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), or Certified Clinical Research Coordinator (CCRC).

If this description aligns with your skills and expertise, we encourage you to consider this opportunity.

  • Clinical Trials Operations Manager

    2 weeks ago

    Nutley, New Jersey, United States Hackensack Meridian Health Full time

    OverviewAt Hackensack Meridian Health, our team members are the foundation of our success. We are dedicated to helping our patients lead healthier lives while fostering an environment where our employees can thrive. Our culture emphasizes connection and collaboration, where competitive benefits are just the starting point. It's about mutual support and...

  • Operations and Growth Manager

    5 days ago

    Nutley, New Jersey, United States Pro Talent Solutions Full time

    About the Role:We are seeking an experienced and motivated business development/operations professional with a background in the home care services industry. This role involves managing and expanding back-office operations while driving business growth through strategic partnerships and training programs.Key Responsibilities:Operational Management: Oversee...

  • Oncology Sales Representative

    5 days ago

    Nutley, New Jersey, United States Eisai Full time

    About the RoleEisai, a leading pharmaceutical company, is seeking a highly motivated and experienced Oncology Sales Specialist to join our team. As a key member of our sales team, you will be responsible for promoting our innovative oncology products to healthcare professionals and driving sales growth in your assigned territory.Key ResponsibilitiesProduct...

  • Oncology Sales Representative

    3 days ago

    Nutley, New Jersey, United States Eisai Full time

    About the RoleEisai, a leading pharmaceutical company, is seeking a highly motivated and experienced Oncology Sales Specialist to join our team. As a key member of our sales team, you will be responsible for promoting our innovative oncology products to healthcare professionals and driving sales growth in your assigned territory.Key ResponsibilitiesProduct...

  • Clinical Services Supervisor

    2 weeks ago

    Nutley, New Jersey, United States LHC Group Full time

    Position OverviewThe Home Health Care Manager plays a pivotal role in overseeing and coordinating clinical services within the organization. This position is essential for ensuring that patients receive high-quality care in their homes.Key ResponsibilitiesSupervise an interdisciplinary team to guarantee the delivery of comprehensive care to home health...

  • Oncology Sales Specialist

    5 days ago

    Nutley, New Jersey, United States Eisai Full time

    About the RoleEisai, a leading pharmaceutical company, is seeking a highly motivated and experienced Oncology Sales Specialist to join our team. As a key member of our sales force, you will play a critical role in promoting our innovative oncology products and building strong relationships with healthcare professionals.Key ResponsibilitiesProduct Promotion:...

  • Senior Oncology Sales Specialist

    3 days ago

    Nutley, New Jersey, United States Eisai Full time

    About the RoleEisai, a leading pharmaceutical company, is seeking a highly motivated and experienced Senior Oncology Sales Specialist to join our team in San Antonio/Austin, TX. As a key member of our sales team, you will be responsible for promoting our innovative oncology products to healthcare professionals in the region.Key ResponsibilitiesMeet and...

  • Talent Acquisition Operations Manager, North America Region

    1 month ago

    Nutley, New Jersey, United States Ralph Lauren Full time

    Company DescriptionRalph Lauren Corporation (NYSE:RL) is a global leader in the design, marketing and distribution of premium lifestyle products in five categories: apparel, accessories, home, fragrances, and hospitality. For more than 50 years, Ralph Lauren's reputation and distinctive image have been consistently developed across an expanding number of...

  • Oncology Sales Representative

    2 weeks ago

    Nutley, New Jersey, United States Eisai Full time

    At Eisai, our commitment to addressing unmet medical needs and enhancing the healthcare experience for patients, their families, and caregivers is at the core of our human health care (hhc) mission. As a dynamic pharmaceutical organization, we are making significant strides in neurology and oncology, underpinned by a robust focus on research and development....

  • Title Operations Coordinator

    1 week ago

    Nutley, New Jersey, United States Pro Talent Solutions Full time

    Job OverviewPosition: Title Operations CoordinatorJob Responsibilities:Manage and resolve exceptions effectively.Ensure affirmative coverage is maintained.Oversee easements and their documentation.Conduct thorough examination readings.Facilitate clearance processes.Prepare proforma documents and policies.Adhere to lender requirements diligently.Handle...

  • Senior Legal Counsel, Commercial Operations

    14 hours ago

    Nutley, New Jersey, United States Frink Hamlett Legal Solutions, Inc. Full time

    Job SummaryFrink-Hamlett Legal Solutions, Inc. is seeking an experienced Senior Legal Counsel to join our Commercial Operations team. As a key member of our legal department, you will provide critical counsel to our pharmaceutical clients on regulatory matters, including sales and marketing, scientific exchange, and FDA standards.Key...

  • ERP Program Manager

    2 weeks ago

    Nutley, New Jersey, United States Ralph Lauren Full time

    Position OverviewAs part of Ralph Lauren's transformative journey, we are seeking an experienced ERP Project Manager to oversee the implementation of a unified Enterprise Resource Planning (ERP) system. This role is crucial in replacing the existing core operating systems, including SAP, Island Pacific, and Microsoft D 365, with a streamlined solution that...

  • Change Management Lead, NGT

    2 months ago

    Nutley, New Jersey, United States Ralph Lauren Full time

    Company DescriptionRalph Lauren Corporation (NYSE:RL) is a global leader in the design, marketing and distribution of premium lifestyle products in five categories: apparel, accessories, home, fragrances, and hospitality. For more than 50 years, Ralph Lauren's reputation and distinctive image have been consistently developed across an expanding number of...

  • Portfolio Manager, NGT

    4 weeks ago

    Nutley, New Jersey, United States Ralph Lauren Full time

    Company DescriptionRalph Lauren Corporation (NYSE:RL) is a global leader in the design, marketing and distribution of premium lifestyle products in five categories: apparel, accessories, home, fragrances, and hospitality. For more than 50 years, Ralph Lauren's reputation and distinctive image have been consistently developed across an expanding number of...

  • ERP Project Manager- Next Generation Transformation

    4 weeks ago

    Nutley, New Jersey, United States Ralph Lauren Full time

    Company DescriptionRalph Lauren Corporation (NYSE:RL) is a global leader in the design, marketing and distribution of premium lifestyle products in five categories: apparel, accessories, home, fragrances, and hospitality. For more than 50 years, Ralph Lauren's reputation and distinctive image have been consistently developed across an expanding number of...

  • Manager, People Business Partner, Technology

    1 month ago

    Nutley, New Jersey, United States Ralph Lauren Full time

    Company DescriptionRalph Lauren Corporation (NYSE:RL) is a global leader in the design, marketing and distribution of premium lifestyle products in five categories: apparel, accessories, home, fragrances, and hospitality. For more than 50 years, Ralph Lauren's reputation and distinctive image have been consistently developed across an expanding number of...

  • Manager, People Business Partner, Global Marketing

    1 month ago

    Nutley, New Jersey, United States Ralph Lauren Full time

    Company DescriptionRalph Lauren Corporation (NYSE:RL) is a global leader in the design, marketing and distribution of premium lifestyle products in five categories: apparel, accessories, home, fragrances, and hospitality. For more than 50 years, Ralph Lauren's reputation and distinctive image have been consistently developed across an expanding number of...

  • Neurology Account Manager

    5 days ago

    Nutley, New Jersey, United States Eisai Full time

    About the RoleEisai is seeking a highly motivated and experienced Neurology Account Specialist to join our team in a field-based role. As a key member of our sales team, you will be responsible for developing and executing business plans to drive sales growth and profitability in your assigned geography.Key ResponsibilitiesDevelop and Execute Business Plans:...

  • Medical Sciences Professor

    1 week ago

    Nutley, New Jersey, United States Hackensack Meridian Health Full time

    About the RoleHackensack Meridian Health is seeking a highly qualified Medical Sciences Professor to join our team. As a key member of our faculty, you will play a vital role in shaping the educational experience of our students.Key ResponsibilitiesDevelop and implement innovative curricula in histology, cytology, anatomy, and pathology for our pre-clerkship...

  • Medical Sciences Professor

    1 day ago

    Nutley, New Jersey, United States Hackensack Meridian Health Full time

    About the RoleWe are seeking a highly qualified Medical Sciences Professor to join our team at Hackensack Meridian Health. As a key member of our faculty, you will play a critical role in shaping the educational experience of our students.Key ResponsibilitiesDevelop and implement innovative curricula in histology, cytology, anatomy, and pathology for our...