Sr. CTM Contractor

Job Title: Sr. CTM Contractor

Job Number: 36504

Location: Remote, 

Job Description

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

Responsibilities

1. Proactively manage all aspects of clinical trial conduct; identifies, resolves and escalates issues
2. Lead the Clinical Trial Team consisting of members from other functional areas (i.e., Data Management,
Regulatory Affairs, Clinical Supplies) to ensure that trial timelines, budget, and quality metrics are met
3. Ensure clinical trial conduct is in compliance 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 ensures accurate tracking and reporting of study metrics
6. Develop and implement study plans (e.g., monitoring plans, contingency/risk mitigation plans)
7. Provide operational expertise in clinical trial development and execution including input to clinical
protocols, clinical study reports, and CRF design
8. Plan and conduct study specific training (i.e., CRO training, Investigator Meeting, Site Initiation Visits)
9. Make recommendations for the identification and selection of study vendors
10. Assist with vendor budget negotiation, development of scope of work, and contract execution
11. Manage study vendors (i.e., CRO, Central Laboratory); ensuring deliverables are met and issues are
proactively identified and resolved
12. Oversee forecasting of clinical and non-clinical supplies
13. Collaborate effectively with the Clinical Project Lead and Clinical Operations study team, cross-functional
team members and external partners
14. Manage clinical trial budgets within established limits
15. Perform quality control activities (i.e., co-monitoring visits, Trial Master File audits)
16. Approve vendor invoices
17. Provide study-specific direction and mentoring to Clinical Trial Management Associates, and support
staff, as appropriate
18. Provide support and mentoring to other Clinical Trial Managers, as appropriate
19. Participate in Clinical Operations initiatives and programs, as needed
20. Present at Sr. Management meetings, as required

JOB DESCRIPTION

21. Travel is variable and estimated at 20%

Required Skills

1. Bachelor’s Degree preferred
2. Minimum of three (3) years of clinical research experience; direct experience in managing Phase I
through Phase III global clinical trials preferred
3. Therapeutic knowledge preferred
4. Experience/training in the following areas: GxP Regulations, ICH Guidelines, Good Quality Practices, 21
CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and
Application; 21 CFR 11 and Industry Guidance; Computerized Systems Used in Clinical Trials), HIPAA,
Drug Development and Approval Process, Data Management Overview
5. Knowledge of Ex-US regulations a plus
6. Proficiency in MS Office including Word, Excel, and PowerPoint; Project and Visio a plus