Senior Clinical Study Lead

ICON Strategic Solutions; United States; Remote; USD 140,000 - 167,000; Full time

Job summary

An innovative firm is seeking a Senior Clinical Study Lead to oversee high-end global clinical trials. This fully remote position offers a competitive salary and the chance to work with cross-functional teams to deliver impactful clinical studies. The ideal candidate will have extensive experience in clinical trial management, strong leadership abilities, and a data-driven approach to problem-solving. Join a company that values diversity and offers a range of benefits focused on well-being and work-life balance. This is an exciting opportunity to make a significant impact in the healthcare industry.

Benefits

Annual Leave Entitlements

Health Insurance Options

Retirement Planning

Global Employee Assistance Programme

Life Assurance

Childcare Vouchers

Gym Discounts

Travel Passes

Health Assessments

Qualifications

• 10+ years of clinical trial management experience.
• Strong project management and organizational skills.
• Experience with global trial operations and protocol development.

Responsibilities

• Lead complex global clinical trials and oversee vendors and budget.
• Develop study-specific documentation and ensure compliance.
• Conduct risk assessments and manage project timelines.

Skills

Leadership Skills

Interpersonal Skills

Data-Driven Problem Solving

Effective Communication

Vendor Management

Project Management

Negotiation Skills

Understanding of ICH/GCP Guidelines

Education

Bachelor's Degree in Clinical or Health-Related Fields

Licensed Health-Care Professional

Tools

CTMS

TMF

MS Office Applications

Job description

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ICON has opened 2 new Senior Clinical Study Lead Positions.

Fully remote position with starting pay up to $167k (No bonus).

Must currently be working for a CRO, Pharmaceutical or Biotechnology Company, have a bachelor’s degree with at least 10 years clinical and 7 years of trial management.

Responsibilities

1. Responsible for running high-end, complex global clinical trials, deliverables, working with cross-functional teams, overseeing vendors and budget.
2. Lead the cross-functional study team responsible for clinical study delivery and serve as the primary point of contact for leadership and oversight (as required) for the assigned study.
3. Provide operational input into protocol development.
4. Oversee and contribute to the development of study-specific documentation, including CRFs, data management plan, monitoring plan, oversight plan, training plan, data review plan, statistical analysis plan, etc.
5. Oversee setup and maintenance of study systems such as CTMS, TMF, etc.
6. Ensure compliance with clinical trial registry requirements.
7. Identify outsourcing needs and lead engagement, contracting, and management of vendors.
8. Contribute to baseline budget and timeline development and management.
9. Lead risk assessments and develop risk mitigation strategies at the study level.
10. Lead feasibility assessments to select relevant regions and countries for the study.

Qualifications

1. Must currently work for a CRO, Pharmaceutical, or Biotechnology Company, with a bachelor’s degree and at least 10 years of clinical and 7 years of trial management experience.
2. Undergraduate degree or equivalent, preferably in clinical, science, or health-related fields; licensed health-care professional (e.g., registered nurse).
3. 8 years relevant study management experience.
4. Strong interpersonal and leadership skills.
5. Ability to understand and implement strategic directions for clinical studies.
6. Data-driven approach to planning, executing, and problem-solving.
7. Effective communication skills (verbal, written, presentation).
8. Proactive, disciplined, able to meet deadlines, prioritize effectively.
9. Influencing and negotiation skills.
10. Knowledge of industry trends.
11. Ability to build productive teams and collaborations.
12. Vendor management experience.
13. Technical proficiency in trial systems and MS Office applications.
14. Experience with global trial operations, protocol development, and key study documents.
15. Knowledge of ICH/GCP and regulatory guidelines.
16. Strong project management and organizational skills.

What ICON Can Offer You

Our success depends on our people. We focus on building a diverse culture that rewards high performance and nurtures talent.

In addition to a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:

• Annual leave entitlements
• Health insurance options
• Retirement planning
• Global Employee Assistance Programme (TELUS Health)
• Life assurance
• Optional benefits like childcare vouchers, gym discounts, travel passes, health assessments, among others.

Learn more at: https://careers.iconplc.com/benefits

ICON is an equal opportunity employer committed to a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration.

If you need accommodations during the application process due to a medical condition or disability, please let us know or submit a request here.

We encourage you to apply regardless of whether you meet all requirements; you might be exactly what we’re looking for.