Job Title: Senior Clinical Trial Manager

Job Description

The Senior Clinical Trial Manager oversees the strategic operational management of pre- and post-market clinical studies. The role involves improving efficient execution of review and approval processes, contracting, and correspondence with study sites. You will be responsible for developing supporting clinical documents, coordinating site initiation, tracking enrollments, facilitating analyses, and reporting results. You will collaborate closely with Clinical Data Management, Biostatistics, Monitoring, and Regulatory Affairs departments to meet the goals and objectives of the clinical operations program. This includes ensuring study completion, data cleaning, analysis, regulatory submissions, and timely publication of study results. The role requires compliance with Clinical SOPs and GCP/ICH guidelines and supporting the development and periodic revision of Clinical SOPs. You will manage the development and review of study-specific documents and materials such as training presentations, project plans, monitoring plans, study logs, and newsletters. Ensuring operational and regulatory integrity of studies and participating in FDA or other regulatory authority inspections is crucial. You will also ensure that internal project team members are appropriately trained on proper study conduct and business processes. Additional responsibilities include managing relationships with consultants, contributing to budget management, and participating in clinical study site and vendor selection processes. You will support the recruitment, training, and management of Clinical Affairs staff, including Clinical Study Managers, Clinical Research Associates, and Clinical Coordinators.

Hard SkillsClinical SOPs complianceGCP/ICH guidelinesStudy protocols developmentData cleaning and analysisRegulatory submissionsClinical study reportsFDA inspectionsSoft SkillsCollaborationTeam leadershipTraining and developmentProject managementCommunicationProblem-solving

*Please send your resume and 2-3 professional references to hjaquez@ actalentservices.com for more information.*

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.