IQVIA

Manager, FSP Regulatory and Start-Up Team

IQVIA

Durham, NC, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Are you a driven and experienced regulatory professional looking for a leadership role? IQVIA is seeking a highly qualified Manager to lead our FSP Regulatory and Start-Up Team. As the Manager, you will play a critical role in ensuring the success of our clients' clinical trials by providing strategic leadership and guidance to our regulatory and start-up operations. If you have a strong background in regulatory affairs and a passion for driving excellence, we want to hear from you. Join our dynamic and innovative team and make a meaningful impact in the world of clinical research.

  1. Lead and manage the FSP Regulatory and Start-Up Team to ensure the successful delivery of regulatory and start-up services for clients' clinical trials.
  2. Provide strategic leadership and direction to the team, setting clear goals and objectives to drive excellence in service delivery.
  3. Develop and maintain strong relationships with clients to understand their needs and provide customized solutions to meet their regulatory and start-up requirements.
  4. Stay up-to-date with the latest regulatory guidelines and requirements to ensure compliance and adherence to industry standards.
  5. Oversee the preparation and submission of regulatory documents, including clinical trial applications, amendments, and annual reports, ensuring their accuracy and timeliness.
  6. Monitor and track project timelines, budgets, and resource allocations to ensure efficient and effective delivery of services.
  7. Act as a subject matter expert and provide guidance to team members on complex regulatory issues and challenges.
  8. Collaborate with cross-functional teams, including project managers, clinical operations, and business development, to ensure seamless integration and coordination of regulatory and start-up activities.
  9. Conduct performance evaluations and provide ongoing coaching and development opportunities for team members to foster a high-performing and engaged workforce.
  10. Continuously evaluate and improve processes and procedures to optimize efficiency and quality of regulatory and start-up services.
  11. Represent IQVIA and the FSP Regulatory and Start-Up Team at industry conferences, seminars, and client meetings to showcase our capabilities and expertise.
  12. Maintain a strong understanding of the competitive landscape and identify opportunities for growth and expansion of services.
  13. Adhere to company policies and procedures, as well as regulatory and ethical standards, in all aspects of work.
Where is this job?
This job is located at Durham, NC, USA
Job Qualifications
  • Excellent Communication And Interpersonal Skills, With The Ability To Effectively Collaborate With Cross-Functional Teams And External Stakeholders.

  • Bachelor's Or Master's Degree In A Relevant Field Such As Life Sciences, Regulatory Affairs, Or Clinical Research.

  • Minimum Of 5 Years Of Experience In Managing Fsp (Functional Service Provider) Teams In The Pharmaceutical Or Biotech Industry.

  • Strong Knowledge And Understanding Of Global Regulatory Requirements And Guidelines For Clinical Trials.

  • Proven Track Record Of Successfully Leading And Managing Regulatory And Start-Up Activities For Clinical Trials.

Required Skills
  • Quality Assurance

  • Project Management

  • Time Management

  • Contract Negotiation

  • Problem Solving

  • Budget management

  • Team Leadership

  • Risk assessment

  • Regulatory compliance

  • Stakeholder management

  • SOP Development

Soft Skills
  • Communication

  • Conflict Resolution

  • Emotional Intelligence

  • Leadership

  • Time management

  • creativity

  • Teamwork

  • Adaptability

  • Problem-Solving

  • Decision-making

Compensation

According to JobzMall, the average salary range for a Manager, FSP Regulatory and Start-Up Team in Durham, NC, USA is $120,000-$160,000 per year. This may vary depending on factors such as experience, specific job duties, and the company's industry and size.

Additional Information
IQVIA is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedMay 17th, 2024
Apply BeforeJuly 20th, 2025
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About IQVIA

IQVIA, formerly Quintiles and IMS Health, Inc., is an American multinational company serving the combined industries of health information technology and clinical research.

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