Provide leadership to team members and study teams to ensure clinical trials are conducted in accordance with the protocols, Standard Operations Procedures (SOPs), Good Clinical Practices (GCPs), and other applicable regulatory requirements as well as management and mentoring of direct reports.
Integrate monitoring activities with trial start‑up, site activation, and study close‑out processes, thereby creating a seamless end‑to‑end operational flow.
Utilize negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross-functional study team partnership and to ensure effective in-house clinical study team operations.
Collaborate with trial execution leadership to ensure optimal resourcing of the study teams.
Anticipate potential clinical operations process issues and influence and collaborate with the organization in adopting best practices, making recommendations for improvements, or leading development of new processes and continuous improvement of existing processes, tools, reports, and systems.
Provide quality oversight of trial operations to contribute to inspection readiness.
Own Clinical Operations Standard Operating Procedures (SOPs), responsible for review and revision or delegating duties as needed.
Provide management support to the clinical operations team across all trials/programs by way of training, mentoring or review of study specific documents as needed.
Collaborate with colleagues to ensure cross-team, site learnings, and best practices are shared.

Requirements

Bachelor’s degree in life sciences, nursing, pharmacy or related discipline with 10+ years' of progressive industry experience required; or Master’s degree with 8+ years' or progressive industry experience required.
6+ years managing a team of direct reports required.
Strong knowledge of the clinical research, Good Clinical Practices, and regulatory requirements/guidelines.
Proficiency in interfacing with other functions in clinical research.
Excellent English verbal and written communication skills; good organizational and interpersonal skills.
Ability to maintain corporate confidentiality at all times.
Understanding of regulatory requirements and ICH guidelines
Proficiency in MS Office including Word, Excel, PowerPoint, and Outlook.
Proficient with use of Veeva Clinical Vault, CTMS, and TMF.

Benefits

Medical, Dental and Vision Plan Options
Health and Financial Wellness Programs
Employer Assistance Program (EAP)
Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
Healthcare and Dependent Care Flexible Spending Accounts
401(k) Retirement Plan with Company Match
529 Education Savings Program
Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
Paid Time Off (PTO) includes: 11 Holidays
Exempt Employees are eligible for Unlimited PTO
Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical researchGood Clinical Practices (GCP)regulatory requirementsclinical operationsteam managementprocess improvementinspection readinessSOP review and revisiontraining and mentoringdocument review

Soft Skills

leadershipnegotiationfacilitationmeeting managementconflict resolutionorganizational skillsinterpersonal skillscommunication skillscollaborationproblem-solving