Senior Clinical Research Manager

2 weeks ago


Irvine, California, United States Actalent Full time

Position Title:

Senior Clinical Research Manager

We are in search of a Senior Clinical Research Manager to lead the strategic operational oversight of both pre-market and post-market clinical trials.

This position emphasizes the improvement of effective execution in review and approval workflows, contract negotiations, and communication with clinical study sites. Key responsibilities encompass the creation of essential clinical documentation, coordination of site initiation, monitoring participant enrollment, facilitating data analyses, and reporting outcomes.

You will work closely with departments such as Clinical Data Management, Biostatistics, Monitoring, and Regulatory Affairs to ensure the timely accomplishment of study objectives.

Moreover, you will guarantee adherence to Clinical Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP) / International Council for Harmonisation (ICH) guidelines, manage the formulation and evaluation of study-specific documents, and assist with inspections from the FDA or other regulatory bodies.

This role also involves managing relationships with external consultants, contributing to the development of study budgets, and supporting the recruitment and training of Clinical Affairs personnel.

Essential Skills:

  • Clinical SOPs
  • GCP/ICH guidelines
  • Study protocol formulation
  • FDA regulatory inspections
  • Clinical data evaluation
  • Study budget oversight

Interpersonal Skills:

  • Collaboration
  • Effective communication
  • Team leadership
  • Problem-solving
  • Attention to detail
  • Time management

Employment Type: This is a permanent role.

Work Environment:

  • Travel requirements up to 15%
  • Company size under 200 employees
  • Hybrid work model available
  • Remote options for candidates with significant experience in clinical trial management for class III implantable devices

About Actalent: Actalent is a premier provider of engineering and scientific services and talent solutions. We empower innovative companies to advance their engineering and scientific initiatives by connecting them with specialized experts who drive scale, innovation, and speed to market. With a vast network of nearly 30,000 consultants and over 4,500 clients across North America, Asia, and Europe, Actalent collaborates with many Fortune 500 companies.

Diversity, Equity & Inclusion: At Actalent, we believe that diversity and inclusion are fundamental to the equity and success of our workforce.

Our DE&I initiatives include:

  • Recruiting diverse talent
  • Fostering an inclusive workplace through continuous self-reflection
  • Building a culture of care, engagement, and recognition with measurable outcomes
  • Providing growth opportunities for all employees

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



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