Sr. CTM Contractor

The University of Texas MD Anderson Cancer Center; United States; Remote; USD 80,000 - 110,000; Full time

Job summary

A leading cancer center is looking for a Sr. CTM Contractor to oversee clinical trial operations. This role involves managing trials from start to finish, ensuring compliance with regulations, leading cross-functional teams, and mentoring staff. Ideal candidates have substantial clinical research experience and strategic oversight skills.

Qualifications

• Minimum of three years of clinical research experience, with direct management of Phase I-III trials preferred.
• Knowledge of Ex-US regulations is a plus.

Responsibilities

• Oversee and manage day-to-day operations of clinical trials.
• Proactively manage all aspects of clinical trial conduct.
• Lead the Clinical Trial Team and ensure compliance with regulations.

Skills

Clinical research experience

GxP Regulations

ICH Guidelines

Good Quality Practices

Drug Development

Data Management

Therapeutic knowledge

Proficiency in MS Office

Education

Bachelor’s Degree

Tools

MS Project

Visio

Job description

Job Title: Sr. CTM Contractor

Job Number: 36504

Location: Remote

Job Description:

The Clinical Trial Manager oversees and manages the day-to-day operations of one or more clinical trials, including start-up, conduct, and close-out activities.

Responsibilities:

1. Proactively manage all aspects of clinical trial conduct; identify, resolve, and escalate issues.
2. Lead the Clinical Trial Team, including members from Data Management, Regulatory Affairs, and Clinical Supplies, to ensure trial timelines, budget, and quality metrics are met.
3. Ensure clinical trial conduct complies with ICH, GCP, and local regulations.
4. Collaborate with the Clinical Project Lead to identify and manage risks; develop and implement risk mitigation plans.
5. Establish study milestones and ensure accurate tracking and reporting of study metrics.
6. Develop and implement study plans, including monitoring and contingency/risk mitigation plans.
7. Provide operational expertise in clinical trial development and execution, including input to protocols, study reports, and CRF design.
8. Plan and conduct study-specific training, such as CRO training, Investigator Meetings, and Site Initiation Visits.
9. Make recommendations for the selection of study vendors.
10. Assist with vendor budget negotiations, scope of work development, and contract execution.
11. Manage study vendors to ensure deliverables are met and issues are proactively addressed.
12. Oversee forecasting of clinical and non-clinical supplies.
13. Collaborate effectively with the Clinical Project Lead, study team, cross-functional teams, and external partners.
14. Manage clinical trial budgets within established limits.
15. Perform quality control activities, including co-monitoring visits and FTA audits.
16. Approve vendor invoices.
17. Provide study-specific direction and mentoring to Clinical Trial Management Associates and staff.
18. Support and mentor other Clinical Trial Managers as appropriate.
19. Participate in Clinical Operations initiatives and programs.
20. Present at senior management meetings as required.

Travel is variable and estimated at 20%.

Required Skills:

1. Bachelor’s Degree preferred.
2. Minimum of three (3) years of clinical research experience, with direct management of Phase I-III global trials preferred.
3. Therapeutic knowledge preferred.
4. Experience in GxP Regulations, ICH Guidelines, Good Quality Practices, 21 CFR Part 11, HIPAA, Drug Development, and Data Management.
5. Knowledge of Ex-US regulations is a plus.
6. Proficiency in MS Office; experience with Project and Visio is a plus.