AbbVie

Specialist, Country Study Start Up

AbbVie

North Chicago, IL, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

At AbbVie, we are committed to improving the lives of patients around the world through innovative research and development of life-saving medications. As a Specialist for Country Study Start Up, you will play a crucial role in our mission by leading the initiation of clinical trials in your assigned country. We are looking for a highly organized and detail-oriented individual with experience in clinical research and knowledge of regulatory requirements for conducting studies in your country. If you are passionate about making a difference in the healthcare industry and have the necessary qualifications, we invite you to join our team and help us bring life-changing therapies to patients in need.

  1. Lead the initiation of clinical trials in the assigned country.
  2. Ensure compliance with all regulatory requirements for conducting studies in the assigned country.
  3. Collaborate with cross-functional teams to develop study start-up plans and timelines.
  4. Manage and track study start-up activities to ensure timely and efficient execution.
  5. Coordinate with local investigators and study sites to obtain necessary approvals and documentation.
  6. Develop and maintain relationships with key stakeholders, including regulatory authorities and ethics committees.
  7. Conduct feasibility assessments and provide recommendations for study site selection.
  8. Ensure all study start-up activities are completed in accordance with AbbVie's standard operating procedures and quality standards.
  9. Monitor and report on study start-up progress and issues to relevant stakeholders.
  10. Identify and proactively address any potential study start-up challenges.
  11. Provide guidance and support to study teams on country-specific regulations and requirements.
  12. Stay updated on changes in local regulations and incorporate into study start-up processes.
  13. Contribute to the development and improvement of study start-up processes and procedures.
  14. Maintain accurate and complete study start-up documentation.
  15. Act as a subject matter expert on country-specific regulations and requirements for clinical trials.
Where is this job?
This job is located at North Chicago, IL, USA
Job Qualifications
  • Extensive Knowledge Of Regulatory Environment: A Specialist In Country Study Start-Up Should Have A Deep Understanding Of The Regulatory Landscape In The Country They Are Working In. This Includes Knowledge Of Local Regulations, Laws, And Guidelines Related To Clinical Trials And Drug Development.

  • Experience In Study Start-Up: The Ideal Candidate Should Have At Least 3-5 Years Of Experience In Clinical Trial Start-Up Activities, Including Site Selection, Feasibility Assessments, And Contract Negotiation. This Experience Should Be In The Specific Country Or Region Where The Job Is Located.

  • Strong Communication And Interpersonal Skills: As A Specialist In Country Study Start-Up, Effective Communication And Interpersonal Skills Are Crucial. This Role Involves Working With Various Internal And External Stakeholders, Including Regulatory Authorities, Investigators, And Site Staff.

  • Project Management Skills: The Ability To Effectively Plan, Organize, And Manage Multiple Projects Simultaneously Is Essential For Success In This Role. A Specialist In Country Study Start-Up Should Be Able To Prioritize Tasks And Meet Deadlines While Maintaining A High Level Of Quality And Attention To Detail.

  • Cross-Cultural Competence: Working In A Global Company Like Abbvie Requires Cross-Cultural Competence And Sensitivity. The Ideal Candidate Should Have Experience Working With Diverse Teams And Be Able To Adapt To Different Cultural Norms And Practices. Fluency In The Local Language Is Also Highly Desirable.

Required Skills
  • Project Management

  • Data Analysis

  • Communication

  • Time Management

  • Attention to detail

  • Problem Solving

  • Organizational Skills

  • Leadership

  • Research skills

  • Teamwork

  • Adaptability

  • Priorit

Soft Skills
  • Communication

  • Conflict Resolution

  • Customer Service

  • Leadership

  • Time management

  • Interpersonal Skills

  • Critical thinking

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Specialist, Country Study Start Up in North Chicago, IL, USA is $60,000 - $110,000 per year. This can vary depending on factors such as experience, education, and the specific company and industry. It is important to note that this is just an estimate and salaries may vary.

Additional Information
AbbVie 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 PostedAugust 26th, 2024
Apply BeforeMay 22nd, 2025
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About AbbVie

AbbVie is an American publicly traded biopharmaceutical company founded in 2013. It originated as a spin-off of Abbott Laboratories.

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