Study Director I - Metabolism

LAB Labcorp Early Development Laboratories Inc.; Greenfield (IN); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life

STD/LTD

401(k)

PTO or FTO

Tuition Reimbursement

Employee Stock Purchase Plan

Job summary

Labcorp is seeking a Study Director I – Metabolism for our team in Greenfield, IN. The role leads design, conduct, and reporting of metabolism studies in a GLP/GCP/GMP environment, coordinating cross-functional study teams and maintaining rigorous scientific and regulatory standards.

The position requires a PhD or MS with related experience, strong client relations, and exceptional attention to detail. Labcorp offers a comprehensive benefits package and opportunities for career growth in a

Qualifications

• Bachelor of science degree with 5+ years of experience in research.
• Master of science degree with 2+ years of experience in research.
• PhD degree preferred.

Responsibilities

• Manage design, conduct and reporting of studies to meet scientific, regulatory and client requirements.
• Act as single point of study control for scientific, technical and regulatory conduct and for reporting.
• Coordinate study team efforts and ensure protocol approval and SOP, GLP and regulatory compliance.
• Develop protocols and ensure all protocol amendments are approved and compliant.
• Ensure test and control articles are available and data are obtained and accurate.
• Review cost estimates and monitor financial aspects of studies.
• Prepare and submit reports to the client and assist with client visits.

Skills

Scientific communication

GLP/GCP/GMP awareness

Project coordination

Data interpretation

Report writing

MS Word

MS Excel

MS PowerPoint

Education

Bachelor of science in a related field

Master of science in a related field

PhD degree

Tools

MS Word

MS Excel

MS PowerPoint

Job description

Labcorp is a global leader in laboratory services, providing the insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies and health systems make confident decisions and improve outcomes. Through our unparalleled science, data, technology and laboratory network, we advance diagnostics, accelerate innovation and help address some of the world’s most important health challenges.

As we shape the future of healthcare, we are leveraging advanced technologies, intelligent digital solutions and data-driven innovation across our operations to enhance how work gets done and deliver greater value to customers and patients.

With our global scale and deep expertise, you’ll have the opportunity to do meaningful work, grow your career and make a real impact on people’s health around the world.

Together, we’re improving health and improving lives.

Labcorp is seeking a Study Director I – Metabolism to join our team in Greenfield, IN!

Job Responsibilities

• The Study Director I is responsible for managing the design, conduct and reporting of studies to meet scientific, regulatory and client requirements in a fast-paced environment.
• The Study Director is the single point of study control and has overall responsibility for the scientific, technical, and regulatory conduct of studies as well as for the interpretation, documentation and reporting of results.
• Close and regular liaison with the client is of primary importance.
• Coordinate efforts of the study team.
• Learn to develop protocols and ensure that the protocol, including any changes, is approved and in compliance with appropriate SOPs, GLPs, and regulatory agency guidelines.
• Ensure that test and control articles are available, have been tested for identity, etc., and that appropriate technical data are obtained.
• Also ensure that handling precautions are sufficient to ensure operator’s safety and that this information is given to the operational areas.
• Learn to review cost estimates to ensure that all protocol/amendment driven work scope specifications are included in the price estimation.
• Understand financial status of ongoing studies.
• Monitor progress and status of assigned studies.
• Ensure that all experimental data, including observations of unanticipated responses to the test system, are accurately recorded and verified.
• Direct preparation of reports, ensure compliance with protocol and regulatory requirements, and submit them to the client.
• Participate in and may host client visits.

Minimum Qualifications

• Bachelor of science degree with 5 or more years of experience in research
• or Master of science degree with 2 or more years of experience in research

Preferred Qualifications

• PhD degree
• 2 or more years of experience with In vivo Pharmacokinetics (PK)

Additional Job Standards

• Awareness of requirements for working within a GLP, GCP and GMP (as appropriate) environment
• Basic awareness of the drug development process, regulatory requirements and the scientific techniques of standard metabolism studies required
• Strong client relationship building and management skills
• Ability to communicate effectively verbally and in writingStrong attention to detail, organization, and time management skills
• Skilled in performing scientific presentations and preparing scientific publications
• Experience in a feeder role for a study director with skills and competencies in the relevant study types
• Previous data interpretation and report writing experience
• Working knowledge of MS Word, Excel, PowerPoint and general IT skills

At Labcorp, you can expect the following

• Innovative Environment: Join a leading healthcare organization committed to driving innovation through internal development to help improve health and improve lives.
• Collaborative Culture: Work in a dynamic, inclusive environment that values diverse perspectives and fosters collaboration.
• Benefits:
  • Medical
  • Dental
  • Vision
  • Life
  • STD/LTD
  • 401(k)
  • Paid Time Off (PTO) or Flexible Time Off (FTO)
  • Tuition Reimbursement
  • Employee Stock Purchase Plan

Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan.

Employees regularly scheduled to work less than 20 hours, Casual, Intern, and Temporary employees are only eligible to participate in the 401(k) Plan.

For more detailed information, pleaseclick here. Relocation assistance available

Labcorp is proud to be an Equal Opportunity Employer: Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual.

Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.

We encourage all to apply

If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility.

For more information about how we collect and store your personal data, please see our Privacy Statement.

We believe in the power of science to change lives. Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. Here, you can join our nearly 70,000 employees, serving clients in more than 100 countries, as we work together to transform approaches to patient care.