Lead Clinical Program Manager

2 weeks ago


Atlanta, Georgia, United States VIVEX BIOLOGICS INC Full time
Job Overview

Position Summary

The Senior Clinical Program Manager will play a pivotal role in the management and execution of various clinical trials aimed at generating crucial evidence to support the objectives of VIVEX Biologics. Reporting directly to the VP of Clinical Affairs, this position involves overseeing the implementation and operation of clinical studies, ensuring compliance with regulatory standards and organizational goals.

Key Responsibilities

  1. Ensure the successful execution of clinical studies while adhering to quality standards, timelines, and budget constraints.
  2. Manage relationships with Contract Research Organizations (CROs) and third-party vendors, including selection, contract negotiations, and performance oversight.
  3. Provide guidance and support to CROs to promptly address and resolve study-related issues.
  4. Collaborate with the study team to assess operational feasibility and ensure that timelines align with the clinical development strategy.
  5. Assist in the strategic planning and execution of clinical trials alongside the VP of Clinical Affairs.
  6. Contribute expertise to the development of study protocols and related documentation.
  7. Participate in budget planning and management, ensuring that external expenditures are monitored and controlled.
  8. Work closely with project teams to maintain accurate tracking of budgets, enrollment, and study progress.
  9. Analyze protocol deviations and trends across study sites in collaboration with CROs and external partners.
  10. Coordinate with CROs to identify and mitigate risks and issues at the study level.
  11. Ensure that all clinical studies are prepared for regulatory inspections and may participate in such inspections as needed.
  12. Provide clinical operations insights for key regulatory documents and meetings.
  13. Monitor project risks and develop mitigation strategies to address potential challenges.
  14. Recruit, train, and oversee investigators and their teams to ensure compliance with study protocols.
  15. Facilitate the creation of data presentations for scientific and regulatory purposes.
  16. Develop and implement Evidence Generation and Publication Plans for key products in collaboration with internal and external stakeholders.
  17. Address inquiries related to clinical studies from healthcare professionals and other stakeholders.
  18. Perform additional duties as assigned.

Qualifications

A Bachelor's degree or equivalent in Life Sciences is required, with a Master's degree preferred. Candidates should possess a minimum of ten years of experience in the pharmaceutical or medical device industry, including at least seven years in clinical study management. Proficiency in communication, teamwork, and problem-solving is essential.

Work Environment

This position is based in an office and laboratory environment, requiring the ability to sit for extended periods and occasionally lift up to 20 pounds.

Equal Opportunity Employer

VIVEX Biologics is committed to fostering a diverse and inclusive workplace, ensuring equal opportunity for all employees and applicants.



  • Atlanta, Georgia, United States The Emily Program Full time

    At The Emily Program, we envision a world where individuals maintain harmonious relationships with food, body image, and weight. Our mission is to provide exceptional, personalized care that fosters lasting recovery from eating disorders. Our dedicated team consists of compassionate professionals from diverse backgrounds, working collaboratively to deliver...


  • Atlanta, Georgia, United States Invesco Full time

    About the RoleWe are seeking a highly experienced Senior Program Management Lead to join our team at Invesco. As a key member of our organization, you will be responsible for leading and managing complex security projects and programs, ensuring they are delivered on time, within budget, and to the required quality standards.Key ResponsibilitiesProgram...


  • Atlanta, Georgia, United States Microsoft Corporation Full time

    Microsoft Corporation is seeking a Lead Technical Program Manager to join our dynamic team in Atlanta, Georgia. Are you a problem-solver with a passion for customer satisfaction and a curiosity for AI (Artificial Intelligence)? If so, we invite you to be part of our mission to transform Microsoft Cloud customers into enthusiastic advocates. The Azure...


  • Atlanta, Georgia, United States Invesco Full time

    As a prominent player in the asset management sector, Invesco is committed to assisting investors globally in achieving their financial aspirations. By harnessing the strength of our unique investment management expertise, we offer a diverse array of investment strategies and vehicles to our clients worldwide. If you seek intellectually stimulating work,...


  • Atlanta, Georgia, United States U.S. Bank Full time

    At U.S. Bank, we are committed to excellence in serving our customers and the communities we support. Our mission is to empower individuals and businesses to make informed financial choices while fostering growth and success. We recognize that each team member brings unique potential, and a career with U.S. Bank offers a diverse array of opportunities to...


  • Atlanta, Georgia, United States Core Clinical Management LLC Full time

    Job Description**Job Summary:**We are seeking a highly skilled Clinical Logistics Nurse to join our team at Core Clinical Management LLC. As a Clinical Logistics Nurse, you will play a critical role in improving the quality and efficiency of care for hospitalized patients.Key Responsibilities:Process Improvement: Collaborate with Medical Directors to develop...


  • Atlanta, Georgia, United States Delta Air Lines, Inc. Full time

    Coordinator, Clinical Programs and Advocacy United States, Georgia, Atlanta Global Health and Wellbeing 19-Aug-2024 Ref #: 25743 How you'll help us Keep Climbing (overview & key responsibilities) In partnership with the Clinical Programs & Advocacy team and leadership, this position in GHW is responsible for intake of calls and electronic communications...


  • Atlanta, Georgia, United States Clinical Management Consultants Full time

    Job SummaryWe are seeking a highly experienced and skilled Nurse Director to lead our Medical Surgical Unit. As a key member of our leadership team, you will be responsible for driving excellence in patient care, team collaboration, and operational efficiency.Key ResponsibilitiesLead a team of Medical Surgical RNs in providing high-quality patient...


  • Atlanta, Georgia, United States Kyo, LLC Full time

    About the RoleKyo, LLC is a leading provider of child-centric Applied Behavior Analysis (ABA) services, serving thousands of children and teens across nine states. As a Behavioral Therapist - Clinical Lead, you will play a critical role in delivering comprehensive, effective, and individualized treatment to our clients.Key ResponsibilitiesDirect Kyo client...


  • Atlanta, Georgia, United States Piedmont Atlanta Hospital Full time

    Job SummaryPiedmont Atlanta Hospital is seeking a skilled Nurse Manager to oversee the daily operations of our Mason Transplant Clinic. As a key member of our transplant team, you will be responsible for providing exceptional patient care and leading a team of clinical staff.Key ResponsibilitiesCoordinate the delivery of quality nursing care for patients...

  • Clinical Counselor

    4 days ago


    Atlanta, Georgia, United States Workplace Options Full time

    Job DescriptionAbout UsWorkplace Options is a leading provider of holistic wellbeing solutions, supporting individuals to become healthier, happier, and more productive. With a global network of credentialed providers and professionals, we deliver high-quality care to over 75 million individuals across 116,000 organizations in more than 200 countries and...


  • Atlanta, Georgia, United States The Emily Program Full time

    Position OverviewAs a Clinical Nutrition Specialist, you will play a vital role in delivering exceptional nutrition therapy to a diverse group of clients. Your expertise will be essential in crafting personalized care plans through comprehensive nutrition assessments and ongoing monitoring of medical conditions.Key Responsibilities- Conduct thorough...


  • Atlanta, Georgia, United States Stratfield Consulting Full time

    Job OverviewStratfield Consulting is seeking a highly skilled Program Enablement Lead to provide expert services related to our Client's Global Human Resource Information System (HRIS) team. The ideal candidate will have a strong background in HRIS portfolio management and will be responsible for developing tools and processes to support experience and...


  • Atlanta, Georgia, United States LTIMindtree Full time

    About LTIMindtree:LTIMindtree stands as a premier global technology consulting and digital solutions provider, empowering enterprises across various sectors to redefine their business frameworks, enhance innovation, and optimize growth through the utilization of digital technologies. As a trusted partner in digital transformation for over 700 clients,...


  • Atlanta, Georgia, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence...


  • Atlanta, Georgia, United States Northside Hospital Full time

    Job Summary:Northside Hospital is a leading healthcare provider in Atlanta, committed to delivering exceptional patient care and advancing medical excellence. We are seeking a highly skilled Nurse Clinician to join our Outpatient/Procedural Cardiology team.Key Responsibilities:Collaborate with multidisciplinary teams to provide direct care and clinical...


  • Atlanta, Georgia, United States Yonah Workforce Solutions Full time

    Why Yonah Workforce Solutions Values BCBA's We are dedicated to building an ABA organization centered around our people and raising the standard of clinical services.Our commitment to low caseloads ensures a focused approach on staff development and growth.Benefit from weekly 1:1 sessions and mentorship guidance from experienced professionals.Enjoy full-time...


  • Atlanta, Georgia, United States Jobot Full time

    Position OverviewExciting Opportunity for a Manager of Neuroscience Nursing ProgramsWe are seeking a dedicated professional to lead our growing Neuroscience Nursing Programs across multiple locations. This role is essential in ensuring the highest standards of patient care and program management.About Us:At our organization, we prioritize the development of...

  • Program Manager

    2 months ago


    Atlanta, Georgia, United States Omnicell Full time

    Job DescriptionJob SummaryDo you want to make a meaningful difference in the quality of healthcare? Omnicell is empowering health systems and pharmacies to radically transform the way they manage medications, so they can achieve the vision of the Autonomous Pharmacy. Join us as we build on our powerful combination of advanced automation, predictive...


  • Atlanta, Georgia, United States Department of the Treasury Full time

    Position OverviewThis role is situated within the Taxpayer Services Division, which encompasses various operational units. The responsibilities associated with this position are critical to the effective functioning of mission-driven programs.Key ResponsibilitiesStrategic Planning: Formulate, organize, and execute extensive analytical studies and initiatives...